[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"idiopathic-pulmonary-fibrosis-ipf\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:idiopathic-pulmonary-fibrosis-ipf":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,33,0,25,[9,50,75,98,145,157,179,207,234,255,274,299,321,351,374,399,419,439,461,485,509,532,566,592,614],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100053230","phase-2-phase-2-clinical-trial-of-mnkd-201-nintedanib-dry-powder-inhalation-in-patients-with-idiopathic-pulmonary-fibrosis-100053230",false,"NCT07679893","Phase 2 Clinical Trial of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis","A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Clinical Trial of the Efficacy and Safety of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis Followed by an Open-Label Extension","INFLO-2","Inclusion Criteria:\n\n* 40-80 years old when signing consent and entering screening.\n* Diagnosed with IPF based on current ATS\u002FERS\u002FJRS\u002FALAT guidelines.\n* Either new to treatment or on a stable dose of pirfenidone and\u002For nerandomilast for at least 3 months before screening.\n* Weighs more than 40 kg (88 lb) at screening.\n* Women who can become pregnant:\n* Must have a negative pregnancy test at screening.\n* Must use an approved birth control method from screening until at least 1 month after the last study dose.\n* Men who can father a child and are sexually active with women who can become pregnant:\n* Must use an approved birth control method during treatment and for at least 3 months after the last study dose.\n* Must not donate sperm during treatment and for at least 3 months after the last study dose.\n* Willing to follow all study rules and restrictions.\n* Willing and able to attend study visits and complete study procedures.\n* Able to perform spirometry (lung function testing) as required by the study.\n\nExclusion Criteria:\n\n* Has a lung disease caused by something other than IPF.\n* Has a connective tissue or autoimmune disease (such as lupus, scleroderma, or rheumatoid arthritis).\n* Has another condition that significantly affects breathing.\n* Has serious heart or blood vessel disease.\n* Has a recent or current infection.\n* Was recently hospitalized for COVID-19, an IPF flare-up, or a lung infection.\n* Has a history of asthma (except childhood asthma that has resolved).\n* Has another medical condition or abnormal test result that may affect study participation or safety.\n* Cannot perform high-quality spirometry testing.\n* Has obstructive lung disease.\n* Has abnormal liver function tests.\n* Has moderate to severe liver disease.\n* Has severe kidney disease.\n* Has recently used high-dose steroids or other immune-suppressing medications.\n* Has active cancer or recent cancer treatment.\n* Is on, or expected to be added to, a transplant list.\n* Had major surgery recently or has planned procedures that could interfere with the study.\n* Has had a severe reaction to nintedanib or cannot take nintedanib safely.\n* Has recently used certain medications that may interact with the study drug.\n* Is currently using, or plans to use, prohibited medications during the study.\n* Has recently participated in another clinical trial.\n* Has current alcohol or drug abuse issues.\n* Donated a significant amount of blood recently.\n* Received a live vaccine recently.\n* Currently smokes, recently smoked, or quit smoking less than 1 year ago.\n* Requires more than 6 L\u002Fmin of oxygen while at rest.","ALL","40 Years","80 Years",{"count":22,"type":23},210,"ESTIMATED","INTERVENTIONAL",[26],"PHASE2","This trial is a randomized, double-blind, placebo-controlled study evaluating the safety and preliminary efficacy of inhaled Nintedanib Dry Powder Inhalation (DPI) in adults with idiopathic pulmonary fibrosis (IPF). Participants are randomized to receive either 2 mg QID, 4 mg BID, or matching placebo for 12 weeks, followed by a 24-week open-label extension in which all participants receive active treatment. The primary focus is on safety-particularly bronchospasm events, lung function changes (FEV1, FEV1\u002FFVC), and adverse event rates and assessing the effectiveness of nintedanib DPI in treating IPF.",[29,30],"Idiopathic Pulmonary Fibrosis","Idiopathic Pulmonary Fibrosis (IPF)",[32,33,34,35,36],"inhalable treatments","lung scarring","Pulmonary fibrosis","fibrosis","pulmonary","RECRUITING","2026-07-09",{"date":40,"type":41},"2026-07-13","ACTUAL",{"date":43,"type":23},"2026-06-30",{"date":45,"type":23},"2028-12",{"name":47,"class":48},"Mannkind Corporation","INDUSTRY",2,{"id":51,"slug":52,"hasResults":12,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":24,"phases":59,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100590548","phase-2-a-phase-2-study-of-lti-03-in-patients-with-idiopathic-pulmonary-fibrosis-100590548","NCT06968845","A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis","A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability and Efficacy of Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03) in Patients With Idiopathic Pulmonary Fibrosis","Inclusion Criteria:\n\n1. Male or female age 40 years or older.\n2. Willing and able to provide written informed consent.\n3. Diagnosis of IPF within 5 years of Screening as confirmed by a centrally read HRCT of the chest as defined by the ATS\u002FERS\u002FJRS\u002FALAT guideline. HRCT lung fibrosis by central read during screening must involve ≥ 10% of the lung and be greater than emphysema involvement of the lung.\n4. Forced vital capacity (FVC) percent predicted ≥ 45% at Screening.\n5. Diffusion capacity of the lungs for carbon monoxide (DLCO), hemoglobin-corrected percent predicted ≥ 30% within 8 weeks prior to Randomization.\n6. Participants receiving nintedanib, pirfenidone, or nerandomilast (where approved for marketing) for IPF treatment must have been on a stable prescribed dose for at least 12 weeks prior to Randomization.\n7. Participants who previously received nintedanib, pirfenidone, or nerandomilast must have discontinued treatment at least 8 weeks prior to Randomization.\n8. Able to adequately self-administer study drug using the protocol-specified inhaler device.\n\nExclusion Criteria:\n\n1. Forced expiratory volume in 1 second (FEV1)\u002FFVC \\\u003C 0.7 at Screening.\n2. Use of N-acetyl cysteine or other supplements including but not limited to quercetin, omega-3 fatty acids, dehydroepiandrosterone, polyphenols, and phytochemicals within 7 days prior to Randomization and through Week 24.\n3. Use of systemic corticosteroids at doses \\> 10 mg\u002Fday of prednisone or equivalent within 28 days prior to Randomization.\n4. Active smoker.\n5. Pulmonary exacerbation within 3 months prior to Screening.\n6. Febrile pulmonary illness requiring antibiotic treatment within 28 days prior to Randomization.\n7. Participation in a clinical study or treatment with an investigational drug or device within 28 days of the Screening Visit (or 5 half-lives of the investigational agent, whichever is longer).\n8. History or evidence at Screening of significant renal impairment with estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73m2.\n9. History or evidence at Screening of significant hepatic impairment with bilirubin \\> 3 mg\u002FdL (\\> 51.3 μmol\u002FL) and albumin \\\u003C 2.8 g\u002FdL (\\\u003C28 g\u002FL) and PT prolongation \\> 6 sec or INR \\> 2.3 while not on anticoagulant medication.\n10. Active or history of malignancies within 5 years prior to Randomization, with the exception of localized nonmetastatic basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix, or prostate cancer.\n11. Serious or active medical or psychiatric condition which, in the opinion of the Investigator, may interfere with treatment, assessment, or compliance with the protocol; or an expected survival of less than 24 weeks.\n\n    Contraception and Pregnancy\n12. Positive pregnancy test in female participants of childbearing potential (defined below).\n13. Female participants who are lactating.\n14. Females of childbearing potential (FOCBP) and men with partners of childbearing potential who do not agree to use an acceptable form of contraception for the duration of study treatment and for at least 90 days after the last dose of study drug. Male participants who do not agree to refrain from donating sperm during this same period.",{"count":58,"type":23},120,[26],"Rationale: LTI-03 is an experimental medication breathed into the lungs using an inhaler. It is being studied for the treatment of Idiopathic Pulmonary Fibrosis (IPF). IPF is a progressive, fatal lung disease caused by the death of lung cells involved in oxygen uptake and by progressive fibrosis (scarring) of the lungs. As the disease progresses, patients experience loss of lung function and increased breathing problems. LTI-03 is hypothesized to treat IPF by protecting and restoring the function of the oxygen uptake cells and by controlling lung fibrosis which may result in improving lung scarring.\n\nThe purpose of this research is to evaluate LTI-03 including: its safety, whether it causes side effects, whether it improves lung scarring, and whether it improves IPF symptoms. LTI-03 will be compared to placebo in patients diagnosed with IPF within the last 5 years. Patients on a stable dose of nintedanib, pirfenidone, or nerandomilast (if available by prescription) may participate.\n\nTrial Design: This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center study that includes a 28-day Screening Period, a 24-week Treatment Period, and 4-week Follow-up Period.\n\nStudy Assessments: Up to 9 visits to the study clinic will be required.\n\nSafety and tolerability will be evaluated with the following assessments: physical examination; collection of vital sign data (heart rate, blood pressure, respiratory rate and peripheral oxygen saturation \\[SpO2\\] via pulse oximetry); heart data collected by 12-lead electrocardiogram; and collection of blood samples for safety laboratory tests. In addition, participants will be asked about any adverse events (side effects) they have experienced between clinic visits, if they have changed any medications, and if they are able to properly use their study drug inhaler.\n\nParticipants will undergo a lung function test (spirometry) at every visit, which will be used to evaluate both safety and efficacy. Another test measuring the diffusion capacity of the lungs for carbon monoxide (DLCO) will be required at Screening only.\n\nBlood samples will also be collected at each visit to measure disease biomarkers. At select visits patients will be asked to complete the Living with Pulmonary Fibrosis questionnaire to evaluate their IPF symptoms. Participants will also undergo a specialized lung scan (HRCT) at Baseline and at the End of Treatment to measure changes in lung fibrosis.\n\nInterventions: LTI-03 and placebo are provided in powder-filled capsules that participants will self- administer using an inhaler. Placebo capsules look like LTI-03 capsules but have no active ingredients. Approximately 120 participants will be randomly assigned in a blinded manner to one of study drug treatment groups.",[30],[29,63,64],"Antifibrotic","Interstitial Lung Disease","2026-07-01",{"date":67,"type":41},"2026-07-02",{"date":69,"type":41},"2026-02-02",{"date":71,"type":23},"2027-12-31",{"name":73,"class":48},"Rein Therapeutics",21,{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":18,"minAge":83,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":24,"phases":86,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":90,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":97},"100589192","phase-2-an-extension-study-of-subjects-who-received-an-avalyn-inhaled-antifibrotic-agent-sail-100589192","NCT06951217","An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)","A Multinational, Long-Term, Safety and Tolerability, Open-Label Extension Study of Subjects Who Have Participated in Avalyn Pharma Studies of Inhaled Antifibrotic Agents (AP-LTE-008 [SAIL])","SAIL","Inclusion Criteria:\n\n* Previously participated in an Avalyn-sponsored inhaled antifibrotic clinical study for subjects with either idiopathic pulmonary fibrosis (IPF) (IPF subjects are excluded from the US and Canada) or progressive pulmonary fibrosis (PPF) and with the approval of the Study Physician.\n\nPrevious participation is defined as: Having completed the final visit of the Treatment Period on the full dose of study drug (either active or placebo).\n\n* Male subjects and female subjects of childbearing potential (FOCBP) agree to use highly effective contraception measures from the time of first dose of study drug (for the male subject) or the signing of the informed consent form (ICF) (for the female subject), during the study, and until 90 days after the last dose of study drug. Subjects agree not to donate eggs or sperm during the same period.\n\nExclusion Criteria:\n\n* Have not previously participated in an Avalyn-sponsored inhaled antifibrotic lead-in study or if the subject was permanently discontinued from the lead-in study for any reason. Subjects who discontinued study drug but continued to attend study visits are ineligible.\n* Subjects who experienced an exacerbation of asthma or of chronic obstructive pulmonary disease (COPD) requiring oral or systemic corticosteroids within 3 months of Day 1 (Screening\u002FBaseline Visit).\n* Subjects who experienced an acute exacerbation of IPF (IPF subjects are excluded from the US and Canada) or of PPF within 3 months of Day 1 (Screening\u002FBaseline Visit).\n* Participation in a concurrent clinical study or in a clinical study in which any other investigational drug product aside from the Avalyn nebulized antifibrotic medication from their lead-in study was administered within the previous 30 days, or 5 half-lives of the previously administered investigational product, whichever is shorter. Subjects may be enrolled in registries.\n* History of hypersensitivity and\u002For allergic reaction to pirfenidone or the excipients to be used in this study.","18 Years",{"count":85,"type":23},340,[26],"This is an open-label extension study for participants who were previously enrolled in and completed an Avalyn Pharma Sponsored study with an inhaled antifibrotic, such as AP01. Eligible participants will have their final dose of drug at the end of study visit from the lead-in study and first AP-LTE-008 study visit on the same day.",[89,30],"Progressive Pulmonary Fibrosis",{"date":67,"type":41},{"date":92,"type":41},"2025-04-17",{"date":94,"type":23},"2031-12-31",{"name":96,"class":48},"Avalyn Pharma Inc.",54,{"id":99,"slug":100,"hasResults":12,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":12,"sex":18,"minAge":83,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":24,"phases":108,"briefSummary":110,"conditions":111,"keywords":116,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":136,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":144},"100630072","optimizing-the-diagnostic-journey-in-interstitial-lung-disease-the-optimize-ild-1-trial-100630072","NCT07482917","Optimizing the Diagnostic Journey in Interstitial Lung Disease: The OPTIMIZE-ILD-1 Trial","OPTIMIZE-ILD-1: A Randomized, Pragmatic, Parallel-Group Trial Evaluating the Impact of an Optimized Diagnostic Circuit on Time to Diagnosis in Patients With Suspected Interstitial Lung Disease","OPTIMIZE-ILD-1","Inclusion Criteria:\n\n* Age 18 years or older.\n* Referral for suspected or undiagnosed interstitial lung disease (ILD).\n* At least one of the following:\n\n  * A finding suggestive of ILD (such as reticulation, ground-glass opacities, traction bronchiectasis or honeycombing) not attributable to another disease, on a CT available at referral that includes the lung parenchyma, regardless of its indication; or\n  * Persistent or progressive shortness of breath or chronic cough not attributable to another disease, accompanied by at least one of the following: an interstitial or reticular pattern on chest radiograph; reduced forced vital capacity; persistent bibasilar crackles or digital clubbing; a relevant environmental or occupational exposure, autoimmune disease, or suspected drug or radiation toxicity; or a first-degree family history of ILD.\n* Ability to provide informed consent.\n\nExclusion Criteria:\n\n* Complete ILD diagnostic work-up already performed (chest CT plus full pulmonary function testing including six-minute walk test plus complete ILD laboratory panel).\n* Established diagnosis of ILD previously assigned by another center or specialist.\n* Clinical instability or acute illness that would prevent reliable completion of diagnostic procedures (e.g., respiratory infection, suspected acute ILD exacerbation, acute heart failure).\n* Acute iatrogenic pneumonitis (drug-, chemotherapy- or radiation-induced) with a clear temporal relationship to the offending agent.\n* Medical, functional, psychiatric or logistical limitations that, in the investigators' opinion, would interfere with the diagnostic process or data collection.\n* Participation in another interventional clinical trial that may alter the frequency or timing of diagnostic procedures.\n* Cognitive impairment that prevents informed consent or completion of study questionnaires.\n* Refusal to participate or to allow the collection or use of clinical data.",{"count":107,"type":23},92,[109],"NA","The OPTIMIZE-ILD-1 trial is a prospective, randomized, open-label clinical trial designed to evaluate the impact of a coordinated diagnostic pathway on patients with suspected interstitial lung disease (ILD). In routine clinical practice, diagnostic workflows for ILD are frequently fragmented, involving multiple independent appointments that can lead to significant delays and increased burden for patients and caregivers. This study compares the standard diagnostic pathway against an optimized circuit where core diagnostic procedures-such as high-resolution CT, pulmonary function tests, and laboratory panels-are pre-bundled and scheduled within a coordinated and compressed timeframe.\n\nAll eligible patients referred for suspected ILD are included consecutively to ensure a pragmatic, real-world representation of the referral population. The primary objective is to measure the time to diagnostic communication, defined as the duration from randomization to the date the patient is formally informed of the final diagnosis following a multidisciplinary team (MDT) consensus. Secondary objectives include assessing the time to MDT diagnosis, the time to treatment initiation (when clinically indicated), socioeconomic cost-burden, and the environmental carbon footprint of the diagnostic journey. Furthermore, the study evaluates health-related quality of life, psychological distress, and clinical frailty, while exploring factors such as language proficiency as determinants of diagnostic equity. Caregiver-related outcomes, including burden and experience measures, are contingent upon the presence of a primary caregiver and the provision of their independent informed consent.\n\nThe design of this protocol was informed by a patient focus group and is officially endorsed by the 'AIRE' Associació Catalana de Malalts i Trasplantats Pulmonars, ensuring a patient-centered approach that prioritizes the diagnostic journey's efficiency and human impact.",[112,113,114,30,115],"Interstitial Lung Disease (ILD)","Suspected Interstitial Lung Disease","Fibrotic Interstitial Lung Disease","Interstitial Lung Disease Due to Connective Tissue Disease (Disorder)",[64,117,118,119,29,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135],"ILD","Suspected ILD","Pulmonary Fibrosis","Connective Tissue Disease-ILD","IPF","Diagnostic Pathway","Diagnostic Delay","Multidisciplinary Discussion","One-Day ILD Clinic","Time to Diagnosis","Time to Treatment Initiation","Organizational Intervention","Health Services Research","Diagnostic Workflow Optimization","Patient Experience","Quality of Life","Pulmonary Function Tests","High-Resolution CT","Carbon Footprint",{"date":67,"type":41},{"date":138,"type":41},"2026-03-09",{"date":140,"type":23},"2028-03-01",{"name":142,"class":143},"Hospital de Granollers","OTHER",1,{"id":146,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":147,"targetDuration":4,"studyType":24,"phases":148,"briefSummary":27,"conditions":149,"keywords":150,"overallStatus":151,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":154,"completionDateStruct":155,"leadSponsor":156,"locationsCount":144},"100645054",{"count":22,"type":23},[26],[29,30],[32,33,34,35,36],"NOT_YET_RECRUITING","2026-06-25",{"date":65,"type":41},{"date":43,"type":23},{"date":45,"type":23},{"name":47,"class":48},{"id":158,"slug":159,"hasResults":12,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":24,"phases":167,"briefSummary":168,"conditions":169,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":178},"100641773","phase-2-a-phase-iib-study-to-evaluate-azd8965-in-participants-with-ipf-100641773","NCT07652658","A Phase IIb Study to Evaluate AZD8965 in Participants With IPF.","A Phase IIb Study to Evaluate the Efficacy, Safety, and Tolerability of AZD8965 in Participants With Idiopathic Pulmonary Fibrosis (IPF) (ARGiNAUT)","ARGiNAUT","Inclusion Criteria:\n\n1. Age ≥ 40 years\n2. IPF diagnosis\n3. Participants with IPF receiving locally approved antifibrotic therapies at a stable dose, or participants with IPF not receiving local standard of care\n4. FVC ≥ 45% predicted of normal\n5. DLCO corrected for hemoglobin ≥ 25% predicted of normal\n\nExclusion Criteria:\n\n1. ILD other than IPF\n2. The extent of emphysema is greater than the extent of fibrotic changes on chest HRCT scan\n3. Acute exacerbation of IPF\n4. Lower respiratory tract infection requiring treatment\n5. Acute coronary syndrome\u002Facute myocardial infarction, unstable angina ± coronary intervention with Percutaneous Coronary Intervention, or Coronary Artery Bypass Grafting\n6. Heart failure\n7. History of organ transplantation or is likely to receive lung transplantation",{"count":166,"type":23},359,[26],"This Phase IIb study aims to evaluate the efficacy, safety, and tolerability of 3 doses of AZD8965 treatment compared to placebo in participants with IPF, including those on antifibrotic therapy (nintedanib, pirfenidone, nerandomilast), either alone or in combination, or in those not on antifibrotic therapy.",[30],"2026-06-24",{"date":152,"type":41},{"date":173,"type":41},"2026-06-11",{"date":175,"type":23},"2028-09-14",{"name":177,"class":48},"AstraZeneca",190,{"id":180,"slug":181,"hasResults":12,"nctId":182,"briefTitle":183,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":12,"sex":18,"minAge":185,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":188,"phases":4,"briefSummary":189,"conditions":190,"keywords":194,"overallStatus":151,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":144},"100637681","a-comparison-of-a-medication-adherence-platform-fortiskap-vs-usual-care-in-subjects-on-oral-medications-for-the-treatment-of-interstitial-lung-disease-sarcoid-and-pulmonary-hypertension-100637681","NCT07613216","A Comparison of a Medication Adherence Platform (FORTISKAP™) vs. Usual Care in Subjects on Oral Medications for the Treatment of Interstitial Lung Disease, Sarcoid and Pulmonary Hypertension","Inclusion Criteria:\n\n1. 21 years of age or older at time of enrollment\n2. Primary diagnosis of interstitial lung disease (including sarcoidosis) AND\u002FOR pulmonary hypertension\n3. Currently managing their oral medications independently (i.e., without requiring caregiver administration)\n4. At least one oral medication with a primary indication for treatment of ILD or PH already in use, or planned for initiation with insurance approval secured, at the time of enrollment\n5. 6-Minute Walk Test (6MWT) scheduled within the next 30 days or performed within the past 30 days\n6. For ILD subjects: FVC and\u002For DLCO scheduled within the next 30 days or performed within the past 90 days\n7. For PH subjects: Cardiac echocardiography scheduled within the next 30 days or performed within the past 90 days\n8. Daily access to a smartphone compatible with the FORTISKAP™ companion application\n9. Proficient in English\n\nExclusion Criteria:\n\nFailure to meet any one of the above inclusion criteria","21 Years",{"count":187,"type":23},100,"OBSERVATIONAL","This study will evaluate whether participants with serious lung diseases such as idiopathic pulmonary fibrosis, sarcoidosis, and pulmonary hypertension who use the FORTISKAP™ smart medication cap - a bottle-top device that tracks prescription bottle openings and sends dose reminders to participants and their care team - take their medications more consistently and experience better health outcomes compared to similar participants receiving standard care without the device. Participation requires no changes to prescribed medications, testing or clinical visits beyond what is already part of routine care; participants use a modified medication bottle equipped with the FORTISKAP™ cap for nine months.",[30,191,192,193],"Sarcoidosis Lung","Pulmonary Hypertension","Usual Interstitial Pneumonia",[195,64,196,197],"medication adherence","nintedanib","pirfenidone","2026-05-26",{"date":200,"type":41},"2026-05-29",{"date":202,"type":23},"2026-07",{"date":204,"type":23},"2027-08",{"name":206,"class":48},"Cosmos Rx, Inc",{"id":208,"slug":209,"hasResults":12,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":4,"eligibilityCriteria":213,"healthyVolunteers":214,"sex":18,"minAge":83,"maxAge":215,"enrollmentInfo":216,"targetDuration":4,"studyType":24,"phases":218,"briefSummary":220,"conditions":221,"keywords":222,"overallStatus":151,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":144},"100640559","phase-1-a-phase-i-study-of-hw241045-in-healthy-subjects-100640559","NCT07593690","A Phase I Study of HW241045 in Healthy Subjects","A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of HW241045 Tablets After Single and Multiple Dosing in Healthy Study Participants.","Key Inclusion Criteria:\n\n* The study participant is able to communicate well with the investigator, understand and comply with all requirements of the study, fully comprehend the purpose, nature and methodology of the trial as well as potential adverse reactions, and sign the informed consent form prior to initiation of any study procedures.\n* Healthy male and female study participants aged 18 to 45 years (inclusive).\n* Female study participants shall have a body weight ≥ 45 kg, male study participants ≥ 50 kg; body mass index (BMI) ranges from 19 to 26 kg\u002Fm² (inclusive).\n\nKey Exclusion Criteria:\n\n* Any study participant with a past or current clinically severe or chronic disease involving the circulatory, endocrine, nervous, digestive, respiratory, hematologic, or immune system, as well as psychiatric disorders and metabolic abnormalities; or with any other disease deemed by the investigator likely to interfere with the trial results.\n* Participants with a history of gastrointestinal, hepatic or renal diseases that may affect drug absorption or metabolism, or with known or suspected diseases that may interfere with drug intake, transportation, absorption, distribution, metabolism or excretion.\n* Participants with a history of drug or food allergy, allergic diseases, or allergic constitution (allergic to two or more substances), or with a confirmed allergy to any component of the study drug.\n* Participants who have used any drugs that inhibit or induce hepatic drug metabolism within 30 days prior to the trial or during the trial period.\n* Participants with any other factors deemed unsuitable for participation in the clinical study by the investigator.",true,"45 Years",{"count":217,"type":23},102,[219],"PHASE1","This is a Phase I, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and food effect (FE) of HW241045 in healthy participants.\n\nThis study consists of three parts:1）Part A: A single-dose, two-period, two-way crossover design to evaluate the safety and pharmacokinetic differences between Formulation A and Formulation B of HW241045 tablets; 2）Part B: A single-dose ascending dose design to evaluate the safety, tolerability, and pharmacokinetic profiles of HW241045 Formulation B following single administration. A food-effect study is nested within this part.3）Part C: A multiple-dose ascending dose design to evaluate the safety, tolerability, and pharmacokinetic profiles of HW241045 Formulation B after multiple administrations.",[30],[223,29,224],"HW241045","healthy participants","2026-05-12",{"date":227,"type":41},"2026-05-18",{"date":229,"type":23},"2026-06",{"date":231,"type":23},"2027-01",{"name":233,"class":48},"Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.",{"id":235,"slug":236,"hasResults":12,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":241,"targetDuration":4,"studyType":24,"phases":243,"briefSummary":244,"conditions":245,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":144},"100627320","phase-2-phase-ii-clinical-study-of-bc006-in-patients-with-idiopathic-pulmonary-fibrosis-100627320","NCT07447102","Phase II Clinical Study of BC006 in Patients With Idiopathic Pulmonary Fibrosis","A Phase II Clinical Study to Evaluate the Efficacy and Safety of BC006 in Patients With Idiopathic Pulmonary Fibrosis","Inclusion Criteria:\n\n* Must provide written informed consent form (ICF) indicating understanding of the study and voluntary participation.\n* Aged ≥40 years at the time of signing the ICF, with no gender restriction.\n* Diagnosis of idiopathic pulmonary fibrosis (IPF) according to the 2022 American Thoracic Society\u002FEuropean Respiratory Society\u002FJapanese Respiratory Society\u002FLatin American Thoracic Society (ATS\u002FERS\u002FJRS\u002FALAT) clinical practice guideline.\n* HRCT pattern consistent with usual interstitial pneumonia (UIP) or probable UIP for IPF confirmed by independent central imaging review (acceptable-quality HRCT obtained within 12 months prior to screening or during the screening period). If HRCT shows indeterminate UIP, the diagnosis of IPF must be confirmed by histopathology from a prior lung biopsy (surgical\u002Fvideo-assisted thoracoscopic lung biopsy or bronchoscopic cryobiopsy) recognized by the investigator, if available.\n* Forced vital capacity percent predicted (FVC% predicted) ≥45% during the screening period.\n* Diffusing capacity of the lung for carbon monoxide percent predicted (DLCO% predicted), corrected for hemoglobin (Hb), ≥30% and ≤90% during the screening period.\n* Meets either of the following:\n\n  * The patient has been on a stable dose of nintedanib or pirfenidone for at least 8 weeks prior to screening and during screening (nintedanib ≥100 mg BID, pirfenidone ≥400 mg TID, no dose changes), tolerates the treatment, and plans to continue this background therapy during the study.\n  * The patient has not received nintedanib or pirfenidone for at least 4 weeks prior to screening and during screening (previous treatment discontinued or treatment-naïve), and does not plan to initiate or re-initiate nintedanib or pirfenidone during the study. No patient should discontinue approved therapy to participate in this study. Treatment-naïve patients must decline after full discussion with the investigator regarding the risks\u002Fbenefits of such therapy.\n* Patients of reproductive potential (male and female) must agree to use highly effective contraceptive methods (hormonal, barrier, or abstinence) from signing the ICF until at least 6 months after the last dose of study drug.\n\nExclusion Criteria:\n\n* Interstitial lung disease of known etiology (e.g., domestic and occupational environmental exposures, connective tissue disease, drug toxicity, etc.).\n* Other pulmonary diseases considered clinically significant by the investigator (e.g., asthma, chronic obstructive pulmonary disease, cavitary or pleural disease, etc.).\n* Emphysema ≥ 50%, or emphysema greater than fibrosis, as determined by independent central imaging review of HRCT.\n* Acute exacerbation of IPF within 3 months prior to screening or during the screening period, as judged by the investigator.\n* Sustained improvement in IPF severity within 12 months prior to screening or during the screening period, as judged by the investigator based on changes in FVC, DLCO, and\u002For chest HRCT scan.\n* Pre-bronchodilator forced expiratory volume in 1 second (FEV1)\u002FFVC \\\u003C 0.70 during the screening period.\n* Known increase in FEV1 and\u002For FVC ≥ 12% and ≥ 200 mL post-bronchodilator.\n* History of smoking within 3 months prior to screening or during the screening period, or inability to refrain from smoking (including cigarettes, cigars, pipes, and e-cigarettes) for the duration of the study.\n* Completed a cardiopulmonary rehabilitation program focusing on exercise training within 8 weeks prior to screening, or planning to initiate such a program during the study.\n* Presence of pulmonary hypertension or cor pulmonale that, in the investigator's opinion, would significantly limit compliance with study requirements or may affect assessment of study safety or efficacy.\n* History of lung volume reduction surgery or lung transplantation, or planning to undergo lung volume reduction surgery or lung transplantation during the study (patients on a lung transplant waiting list are permitted).\n* Major surgery within 4 weeks prior to screening or during the screening period, or planning major surgery during the study (assessed as major surgery by the investigator).\n* History of severe cardiovascular or cerebrovascular disease, including but not limited to: ventricular arrhythmia requiring clinical intervention; uncontrolled atrial arrhythmia; congestive heart failure meeting New York Heart Association (NYHA) functional Class ≥ III; previous evidence of left ventricular ejection fraction (LVEF) \\\u003C 35%; uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg) or poor compliance with antihypertensive medications; acute coronary syndrome, stroke, or transient ischemic attack within 6 months prior to screening.\n* Current or suspected malignancy, or history of malignancy within 5 years prior to screening (excluding basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, or other carcinoma in situ that has received curative treatment with no recurrence).\n* Active autoimmune disease, or history of autoimmune disease that may relapse (e.g., systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis, etc., including but not limited to these diseases or syndromes).\n* Acute respiratory or systemic bacterial, viral, or fungal infection requiring antimicrobial therapy within 4 weeks prior to screening or during the screening period.\n* Active hepatitis B or hepatitis C. Active hepatitis B is defined as positive hepatitis B surface antigen (HBsAg) and HBV DNA \\> upper limit of normal (ULN). Active hepatitis C is defined as positive hepatitis C antibody (HCV-Ab) and HCV RNA \\> ULN.\n* History of immunodeficiency, including positive human immunodeficiency virus (HIV) antibody test.\n* Positive interferon-γ release assay for tuberculosis during the screening period (testing is not required for patients who completed treatment for active or latent tuberculosis within 6 months prior to screening with no evidence of recurrent disease).\n* Presence of any of the following laboratory abnormalities during the screening period: AST or ALT \\> 1.5 × ULN; Total bilirubin \\> 1.5 × ULN; Creatinine (Cr) \\> 1.5 × ULN\n* Prior treatment with a highly selective small-molecule CSF-1R inhibitor (excluding nintedanib), or anti-CSF-1\u002FCSF-1R antibody.\n* Known allergy or contraindication to the investigational product components or excipients, or history of hypersensitivity or severe infusion reaction to antibody-based products.\n* Received an investigational drug within 4 weeks prior to screening or within 5 half-lives (whichever is longer) or during the screening period.\n* Received other newly approved anti-fibrotic therapies other than nintedanib and pirfenidone within 4 weeks prior to screening or during the screening period, or planning to receive such therapies during the study.\n* Received combination therapy with nintedanib and pirfenidone within 8 weeks prior to screening or during the screening period.\n* Received cytotoxic, immunosuppressive, cytokine-modulating agents, or receptor antagonists (including but not limited to methotrexate, azathioprine, mycophenolate mofetil, cyclophosphamide, cyclosporine, everolimus) within 4 weeks prior to screening or during the screening period.\n* Received systemic corticosteroid therapy with prednisone \\> 15 mg\u002Fday or equivalent within 4 weeks prior to screening or during the screening period.\n\nPatients taking nintedanib: using or planning to use strong P-glycoprotein (P-gp) inhibitors (e.g., ketoconazole, erythromycin) or inducers (e.g., rifampicin, carbamazepine, phenytoin, St. John's Wort) during screening or the study.\n\nPatients taking pirfenidone: using or planning to use strong CYP1A2 inhibitors (e.g., fluvoxamine, enoxacin) or inducers (e.g., rifampicin) during screening or the study.\n\n* Unable to avoid use of the following medications: Short-acting bronchodilators within 4 hours prior to spirometry and DLCO measurements; Once-daily long-acting bronchodilators within 24 hours prior to spirometry and DLCO measurements; Twice-daily long-acting bronchodilators within 12 hours prior to spirometry and DLCO measurements.\n* Known or suspected history of alcohol or drug abuse within 2 years prior to screening or during the screening period.\n* Pregnant (female patients of childbearing potential confirmed by serum pregnancy test within 7 days prior to first dose of study drug) or lactating female.\n* Any disease, treatment, or abnormal laboratory finding that, in the investigator's opinion, may affect the patient's participation in the entire study, increase patient risk, or confound study results; or participation in the study is not in the patient's best interest, in the investigator's judgment.",{"count":242,"type":23},96,[26],"This is a multicenter, Phase II clinical study to evaluate the efficacy and safety of BC006 over a 24-week treatment period in patients with idiopathic pulmonary fibrosis (IPF). The study consists of two phases: an open-label safety run-in phase and a double-blind, randomized, placebo-controlled phase.",[30],"2026-05-10",{"date":248,"type":41},"2026-05-13",{"date":250,"type":41},"2026-04-27",{"date":252,"type":23},"2029-04-01",{"name":254,"class":48},"Dragonboat Biopharmaceutical Company Limited",{"id":256,"slug":257,"hasResults":12,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":24,"phases":264,"briefSummary":265,"conditions":266,"keywords":4,"overallStatus":151,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":269,"completionDateStruct":270,"leadSponsor":272,"locationsCount":4},"100640523","phase-2-nintedanib-with-or-without-dextromethorphan-in-patients-with-idiopathic-pulmonary-fibrosis-ipf-100640523","NCT07583589","Nintedanib With or Without Dextromethorphan in Patients With Idiopathic Pulmonary Fibrosis (IPF)","A Multicenter, Randomized, Double Blind, Placebo-controlled Clinical Study to Evaluate the Treatment of Nidanib With or Without Dextromethorphan in Idiopathic Pulmonary Fibrosis (IPF) Patients.","Inclusion Criteria:\n\n1. Age ≥40 years old, regardless of gender;\n2. According to \"2022 ATS\u002FERS\u002FJRS\u002FALAT Guidelines\", it was diagnosed as idiopathic pulmonary fibrosis (IPF);\n3. Lung function meets the following conditions during screening: forced vital capacity (FVC) ≥45% predicted value; The dispersion of carbon monoxide (DLco, corrected Hb) in a single breath is between 30% and 80% of the predicted value.\n4. HRCT images completed within 12 months before screening can be used to determine UIP mode;\n5. It is expected to complete the whole research plan, including 12 weeks of treatment and 1 week of follow-up;\n6. Willing to follow all the requirements of drug use, visit and data collection during the study period;\n7. Be able to understand the research content and sign the written informed consent;\n8. Women of childbearing age provide negative pregnancy test results, and agree to take effective contraceptive measures during the study period and within 3 months after the last administration; Male subjects with fertility also need to take effective contraception at the same time.\n\nExclusion Criteria:\n\n1. Suffering from other interstitial lung diseases caused by non-IPF reasons (such as connective tissue disease-related ILD, chronic allergic pneumonia, pneumoconiosis, drug-induced pneumonia, radiation lung disease, etc.);\n2. One or more Acute Exacerbation)； of IPF occurred within 3 months before screening;\n3. Have received a lung transplant;\n4. Complicated with severe COPD(GOLD III and above), severe asthma or other airway diseases that may interfere with FVC determination;\n5. The following systemic immunosuppressive treatments were used within 4 weeks before screening: \\> 15 mg\u002Fd prednisone (or equivalent dose), cyclophosphamide, methotrexate, tuzumab, rituximab, mycophenolate mofetil, etc.\n6. Currently or in the past, allergic to Nidanib, dextromethorphan or any of its auxiliary ingredients;\n7. The following laboratory abnormalities exist: ALT or AST \\>3×ULN；; eGFR \\\u003C30 mL\u002Fmin\u002F1.73m²；\n8. Have a history of uncontrolled mental illness, epilepsy, central nervous system dysfunction, or may induce adverse reactions after using dextromethorphan;\n9. Being receiving drugs that may have serious drug interaction with dextromethorphan, such as monoamine oxidase inhibitor (MAOI) and selective serotonin reuptake inhibitor (SSRI), and unable to stop taking drugs;\n10. Pregnant or lactating women;\n11. At the time of screening, there are other major diseases or medical conditions that researchers think will significantly increase the risk and affect the treatment compliance or data interpretation;\n12. Interventional treatment of other clinical trials within 4 weeks before screening.\n13. Use Nidanib or pirfenidone for anti-fibrosis treatment within 8 weeks before screening;",{"count":263,"type":23},60,[26],"Nintedanib combined with or without Dextromethorphan for the treatment of IPF, with FVC as the primary efficacy endpoint to evaluate its effectivenes.",[30],"2026-05-08",{"date":248,"type":41},{"date":225,"type":23},{"date":271,"type":23},"2027-06-01",{"name":273,"class":143},"First Affiliated Hospital of Wenzhou Medical University",{"id":275,"slug":276,"hasResults":12,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":4,"eligibilityCriteria":280,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":281,"enrollmentInfo":282,"targetDuration":4,"studyType":24,"phases":284,"briefSummary":285,"conditions":286,"keywords":287,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":298},"100619433","phase-1-a-study-to-evaluate-safety-tolerability-and-pharmacokinetics-of-mnkd-201-in-patients-with-idiopathic-pulmonary-fibrosis-100619433","NCT07344558","A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MNKD-201 in Patients With Idiopathic Pulmonary Fibrosis","A Randomized, Double-Blind, Placebo-Controlled, Phase 1b Clinical Study of the Safety, Tolerability, and Pharmacokinetics of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis","Inclusion Criteria:\n\n1. Is ≥40 to ≤85 years of age at the time of signing the informed consent form.\n2. Diagnosis of IPF\n3. Either treatment-naive or is currently on background pirfenidone or nerandomilast on a stable dose for at least 3 months prior to Screening.\n4. Has FVC \\>45% of predicted of normal, as determined by the central spirometry reader, during Screening.\n5. DLCO corrected for hemoglobin \\[Visit 1\\] ≥40% of predicted of normal, within 12 months of Screening. If no historical DLCO is available prior to Screening, this is to be done during Screening and read locally.\n6. Has a body weight \\>40 kg (\\>88 lbs.) at Screening.\n7. For female participants of childbearing potential, agreement to use acceptable birth control\n8. For male participants who can father a child and are having intercourse with females of childbearing potential, agreement to use a protocol-recommended method of contraception\n9. Is capable of performing spirometry, as required by the study procedures and ATS guidelines.\n10. CT chest within 2 years of Screening, consistent with an IPF diagnosis, per investigator assessment.\n\nExclusion Criteria:\n\n1. Known explanation for interstitial lung disease, including but not limited to radiation, sarcoidosis, hypersensitivity pneumonitis, and bronchiolitis obliterans organizing pneumonia.\n2. Diagnosis of any connective tissue disease, including but not limited to scleroderma\u002Fsystemic sclerosis, polymyositis\u002Fdermatomyositis, systemic lupus erythematosus, and rheumatoid arthritis, regardless of whether or not it is presumed to be related to their pulmonary fibrosis diagnosis.\n3. Major extrapulmonary physiological restriction (e.g., chest wall abnormality, large pleural effusion), as determined by the investigator.\n4. Significant Cardiovascular diseases\n5. Recent systemic infection within 4 weeks before the Screening visit or symptomatic viral or bacterial infection at time of Screening.\n6. Prior hospitalization for confirmed coronavirus disease 2019 (COVID-19), acute exacerbation of IPF or any lower respiratory tract infection within 3 months of Screening.\n7. Has a history of asthma, with the exception of resolved childhood asthma.\n8. Has known obstructive lung disease\n9. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin \\>1.5 times the upper limit of normal (ULN) during Screening.\n10. Advanced liver and kidney function.\n11. Current or recent (within 30 days of Screening) use of nintedanib.\n12. Use of prednisone \\>10 mg\u002Fday within 1 month prior to Screening, or other significant immunosuppression\n13. Active lung cancer (primary or metastatic) or any cancer requiring chemotherapy or radiation therapy within 3 years, except appropriately treated non-melanoma skin cancer, localized non-malignant prostate cancer, or in situ carcinoma of uterine cervix.\n14. Has participated in another clinical study of a new chemical entity, new device, or a prescription medicine within the 1 month before Screening\n15. Current alcohol, medication, or illicit drug abuse\n16. Has lost more than 400 mL blood, e.g., as a blood donor, or donor of blood products, during the 3 months prior to Screening.\n17. Has received a live vaccine within the 3 months prior to the first dose of study drug.\n18. Smokes (any substance including electronic cigarettes and marijuana) within 3 months prior to Screening or is an ex-cigarette smoker who gave up \\\u003C1 year ago.\n19. Has oxygen requirement of \\> 6 liters\u002Fmin at rest.","85 Years",{"count":283,"type":23},24,[219],"MKC-NI-002 is a Phase 1b, randomized, double-blind, placebo-controlled study of nintedanib inhalation powder (MNKD-201) in patients with Idiopathic Pulmonary Fibrosis (IPF). The trial consists of Multiple Ascending Doses (MAD) with the primary objective to evaluate safety, tolerability and pharmacokinetics (PK) of MNKD-201 compared to placebo in patients with IPF.",[30],[288,289],"Nintedanib","dry powder inhalation","2026-05-02",{"date":292,"type":41},"2026-05-05",{"date":294,"type":41},"2025-12-22",{"date":296,"type":23},"2026-06-15",{"name":47,"class":48},9,{"id":300,"slug":301,"hasResults":12,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":4,"eligibilityCriteria":305,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":306,"targetDuration":4,"studyType":24,"phases":308,"briefSummary":310,"conditions":311,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":144},"100599311","phase-3-confirmatory-clinical-study-of-hec585-tablets-in-patients-with-ipf-100599311","NCT07082842","Confirmatory Clinical Study of HEC585 Tablets in Patients With IPF","A Multicenter, Parallel, Randomized, Placebo (Double-blind) and Pirfenidone (Open-label) Controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of HEC585 Tablets in Patients With Idiopathic Pulmonary Fibrosis (IPF)","Inclusion Criteria:\n\n1. Voluntarily participate in this clinical study and sign the informed consent form before the study begins;\n2. When signing the informed consent form, the age should be between 40 and 80 years old (inclusive of 40 and 80), and gender is not restricted;\n3. Be diagnosed with IPF according to the diagnostic criteria of the IPF clinical practice guidelines jointly released by the American Thoracic Society, the European Respiratory Society, the Japanese Respiratory Society and the Latin American Thoracic Society in 2022 ; Chest high-resolution computed tomography (HRCT) examination (HRCT examination within 3 months before screening) or lung biopsy (if any) should be confirmed by central reading;\n4. The ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) at the screening period is ≥ 0.7;\n5. The percentage of FVC as a percentage of the normal predicted value at the screening period is ≥ 45%;\n6. The percentage of DLco (hemoglobin \\[Hb\\] corrected) as a percentage of the normal predicted value at the screening period is ≥ 30%;\n7. Female or male subjects with potential fertility agree and commit to taking effective contraceptive measures from the time of signing the informed consent form until 30 days after the last administration of the investigational drug; at the same time, avoid sperm\u002Fegg collection, sperm\u002Fegg donation;\n8. According to the assessment by the investigator, the subjects are willing and able to comply with the requirements of the protocol and attend the visits.\n\nExclusion Criteria:\n\n1. The researchers believe that the subjects experienced significant deterioration of IPF within the first three months of the randomization period.\n2. Other known causes of interstitial lung disease, such as exposure to the home or occupational environment, connective tissue diseases, drug toxicity, etc.\n3. Abnormalities in the lungs or chest that are clinically significant and judged by the researchers to potentially affect the trial results.\n4. Within one month before randomization, any active infection requiring systemic treatment (such as oral or intravenous administration) in the form of activity (including bacterial, viral, parasitic or fungal infections).\n5. Expected to undergo lung transplantation during the course of the study.\n6. Expected survival period less than 6 months.\n7. History of malignant tumors within the previous 5 years (excluding localized cancers such as basal cell carcinoma).\n8. Moderate to severe liver dysfunction (Child-Pugh classification of grade B or C).\n9. Within six months before screening, history of unstable or deteriorating heart disease, including but not limited to the following conditions:\n\n   1. Unstable angina pectoris;\n   2. Myocardial infarction;\n   3. Congestive heart failure requiring hospitalization or NYHA III\u002FIV grade;\n   4. Uncontrolled severe arrhythmia.\n10. Unable to perform the 6MWT or pulmonary function test, such as if the patient is mentally unstable and unable to cooperate, etc.;\n11. Allergic to any component of Ifinonate Hydrochloride Tablets (except the active ingredient, the excipients include microcrystalline cellulose, pre-gelatinized starch, cross-linked povidone, povidone, dibutyl hydroxytoluene, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, polyethylene glycol, talc and titanium dioxide) or pirfenidone tablets;\n12. The last administration of the study drug for other clinical trials occurred within 4 weeks before randomization or 5 half-lives (whichever is longer);\n13. Pregnant or breastfeeding;\n14. Within 3 months before screening, had a smoking history or was unwilling to maintain a smoking-free status during the study;\n15. Within 6 months before screening, frequently drank alcohol \\[average weekly alcohol consumption exceeding 21 units (1 unit = 360 mL of beer, or 150 mL of wine, or 45 mL of 40% alcohol spirits)\\];\n16. Had a history of drug abuse within 6 months before screening;\n17. Has a family or personal history of long QT interval syndrome;\n18. The investigator believes that the subject has conditions that may compromise their safety or compliance, significantly affect the pharmacokinetics of the drug, or prevent them from completing the study.\n19. During the screening period, liver function test values exceeded any of the following standards: total bilirubin \\> 1.5 times the upper limit of normal (ULN); aspartate aminotransferase or alanine aminotransferase \\> 2 times ULN;\n20. During the screening period, glomerular filtration rate \\\u003C 45 mL\u002Fmin\u002F1.73 m2, calculated using the CKD-EPI (based on serum creatinine) formula ;\n21. At the time of screening, human immunodeficiency virus antibody or syphilis spirochete antibody test results were positive;\n22. At the time of screening, there was an uncontrolled hepatitis B virus infection (positive hepatitis B surface antigen, and hepatitis B DNA ≥ 2x102 IU\u002FmL) or hepatitis C virus infection (positive anti-hepatitis C antibody and hepatitis C RNA);\n23. During the screening period, QTcF \\> 480 ms (using the Fridericia formula, QTcF = QT\u002FRR\\^0.33).\n24. Those who have previously taken isoniazidine hydrochloride;\n25. Within the first 4 weeks before randomization, used any of the following treatments:\n\n    1. Any cytotoxic drugs or immunosuppressants, including but not limited to azathioprine, cyclophosphamide, methotrexate, cyclosporine, etc.;\n    2. Pirfenidone or nintedanib;\n    3. \\> 15 mg\u002Fd prednisone or equivalent dose of other glucocorticoids;\n    4. Strong inducers or inhibitors of CYP3A4, CYP2C8 or CYP2C19 (including but not limited to ritonavir, clarithromycin, aletris, carbamazepine, gemfibrozil, fluoxetine, fluvoxamine, etc.);\n    5. Moderate, strong inhibitors or inducers of CYP1A2 (including but not limited to fluvoxamine, ciprofloxacin, enoxacin, etc.).",{"count":307,"type":23},472,[309],"PHASE3","A multicenter, parallel, randomized, placebo (double-blind) and pirfenidone (open-label) controlled Phase III clinical trial to evaluate the efficacy and safety of HEC585 in patients with idiopathic pulmonary fibrosis (IPF)",[30],"2026-04-16",{"date":314,"type":41},"2026-04-21",{"date":316,"type":41},"2025-10-27",{"date":318,"type":23},"2032-02-15",{"name":320,"class":48},"Sunshine Lake Pharma Co., Ltd.",{"id":322,"slug":323,"hasResults":12,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":327,"eligibilityCriteria":328,"healthyVolunteers":12,"sex":18,"minAge":83,"maxAge":4,"enrollmentInfo":329,"targetDuration":4,"studyType":24,"phases":331,"briefSummary":332,"conditions":333,"keywords":334,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":349,"leadSponsor":350,"locationsCount":144},"100630325","optimizing-the-follow-up-journey-in-interstitial-lung-disease-the-optimize-ild-2-trial-100630325","NCT07486206","Optimizing the Follow-Up Journey in Interstitial Lung Disease: The OPTIMIZE-ILD-2 Trial","OPTIMIZE-ILD-2: A Randomized, Pragmatic, Parallel-Group Trial Evaluating the Impact of an Optimized Coordinated Follow-Up Circuit on Time Burden in Patients With Interstitial Lung Disease","OPTIMIZE-ILD-2","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Established diagnosis of interstitial lung disease (ILD).\n* Currently receiving antifibrotic therapy, immunosuppressive therapy, or both, as part of routine ILD care.\n* Under active follow-up at the participating ILD center.\n* Able to attend the required follow-up procedures included in the study visit.\n* Able to provide informed consent.\n\nExclusion Criteria:\n\n* Inability to complete the coordinated follow-up visit for non-medical reasons (e.g., logistical impossibility).\n* Clinical instability or acute illness interfering with planned follow-up procedures (such as respiratory infection, suspected ILD exacerbation, acute heart failure, or other acute conditions).\n* Participation in another interventional clinical trial that may alter visit frequency or follow-up structure.\n* Cognitive impairment preventing informed consent or completion of questionnaires.\n* Patient refusal to participate or refusal to allow data collection.",{"count":330,"type":23},152,[109],"The OPTIMIZE-ILD-2 trial is a prospective, randomized, open-label clinical trial designed to evaluate the impact of a coordinated follow-up pathway on patients with established interstitial lung disease (ILD). In routine clinical practice, follow-up workflows for ILD are frequently fragmented, requiring multiple hospital visits for pulmonary function tests, laboratory analysis, treatment administration, and consultations with various specialists, which increases the burden for both patients and caregivers. This study compares the standard follow-up care against an optimized circuit where all routine monitoring procedures and interdisciplinary consultations are pre-bundled and scheduled within a single, coordinated hospital visit.\n\nAll eligible patients under active ILD follow-up are included consecutively to ensure a pragmatic, real-world representation of the treated ILD population. The primary objective is to measure the total follow-up time burden, defined as the total home-to-home time required to complete the follow-up circuit. As a cross-sectional assessment within a longitudinal context, secondary objectives include assessing socioeconomic cost-burden, the environmental carbon footprint of the follow-up journey, health-related quality of life, and clinical frailty. Caregiver-related outcomes, including burden and experience measures, are contingent upon the presence of a primary caregiver and the provision of their independent informed consent.\n\nThe design of this protocol was informed by a patient focus group and is officially endorsed by the 'AIRE' Associació Catalana de Malalts i Trasplantats Pulmonars, ensuring a patient-centered approach that prioritizes follow-up efficiency and human impact.",[112,114,30,89,115],[64,117,119,29,89,335,336,337,338,339,340,341,342,125,129,343,128,133,132,131,135,344],"CTD-ILD","Fibrotic ILD","Antifibrotic Therapy","Immunosuppressive Therapy","Follow-Up Pathway","Follow-Up Care Coordination","Time Burden","Home-to-Home Time Burden","Patient-Centered Follow-Up","Multidisciplinary Care","2026-04-06",{"date":347,"type":41},"2026-04-09",{"date":138,"type":41},{"date":140,"type":23},{"name":142,"class":143},{"id":352,"slug":353,"hasResults":12,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":357,"eligibilityCriteria":358,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":359,"targetDuration":4,"studyType":24,"phases":361,"briefSummary":362,"conditions":363,"keywords":364,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":373},"100607886","phase-2-aura-ipf-a-randomized-phase-2-study-to-evaluate-the-safety-and-efficacy-of-ap02-nintedanib-solution-in-ipf-100607886","NCT07194382","AURA-IPF: A Randomized Phase 2 Study to Evaluate the Safety and Efficacy of AP02 (Nintedanib Solution) in IPF","A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Proof of Concept (POC) Study Evaluating the Safety, Tolerability, and Efficacy of Nintedanib Solution for Inhalation (AP02) in Participants With Idiopathic Pulmonary Fibrosis (IPF) (AURA-IPF)","AURA-IPF","Inclusion Criteria:\n\n* Male or female patients aged ≥40 years at the time of signing the written informed consent form\n* Diagnosis of idiopathic pulmonary fibrosis (IPF) as defined by American Thoracic Society\u002FEuropean Respiratory Society\u002FJapanese Respiratory Society\u002F Asociación Latinoamericana de Tórax IPF guidelines within 5 years\n* Combination of High-Resolution Computerized Tomography (HRCT) pattern, and if available, surgical lung biopsy pattern consistent with diagnosis of IPF\n* In a stable condition and suitable for study participation based on the results of medical history, physical examination, vital signs, 12-lead ECG, and laboratory evaluation\n* Forced vital capacity (FVC) ≥45% predicted of normal\n* Lung diffusion test (DLCO) corrected for hemoglobin (Hgb) ≥30% and ≤80% predicted of normal.\n* Women and men of childbearing potential must use highly effective contraception measures until 90 days after the last dose of study drug.\n\nExclusion Criteria:\n\n* Current treatment with oral nintedanib, oral pirfenidone, or previous treatment with oral nintedanib or oral pirfenidone within 3 months prior to screening. Participants who have taken both oral nintedanib and pirfenidone together as a treatment will not be able to join the study.\n* Forced expiratory volume (FEV) in the first second\u002FFVC (FEV1\u002FFVC) ratio ≥0.7 based on pre-bronchodilator value\n* Participants with a history of serious cardiovascular disease, bleeding problems or significant liver or kidney disease (as defined in the study protocol)\n* History of diverticular disease or abdominal surgery within 4 weeks prior to screening visit\n* History of cancer within the past 5 years (except for certain types explained in the protocol)\n* Participants who have smoked within the past 3 months prior to screening, who are not willing to stop smoking during the study, or who currently use illegal drugs or drugs of abuse\n* Female participants who are pregnant or nursing\n* Use of any investigational drugs including those for IPF within the past 30 days prior to screening\n\nFurther inclusion\u002Fexclusion criteria apply",{"count":360,"type":23},160,[26],"This study will evaluate the impact Nintedanib Solution for Inhalation (AP02) has on lung function and key measures of fibrosis in adult patients with idiopathic pulmonary fibrosis (IPF) as well as assess its safety and tolerability.\n\nAdults 40 years of age or older with IPF who meet the inclusion and exclusion criteria can participate in this study if they are not currently on treatment for IPF, and if treated with oral nintedanib or pirfenidone, have stopped the medication for at least 3 months.\n\nResearchers will compare two different doses of AP02 to a placebo (a look-alike substance that contains no drug) to see if AP02 works to treat IPF. Participants are put into 1 of 3 groups randomly, which means by chance and will take AP02 or a placebo two times every day for 12 weeks by using a nebulizer, which is a device that provides medicine to the lungs via inhalation.\n\nParticipants will visit the office 6 times and receive 1 phone call over a 16-week period. At site visits doctors regularly perform breathing tests that measure how well the lungs are working, give the patient questionnaires and will check the participants' health.",[30],[29,121,365],"AP02","2026-04-01",{"date":345,"type":41},{"date":369,"type":41},"2026-03-10",{"date":371,"type":23},"2027-06",{"name":96,"class":48},3,{"id":375,"slug":376,"hasResults":12,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":4,"eligibilityCriteria":380,"healthyVolunteers":12,"sex":18,"minAge":83,"maxAge":381,"enrollmentInfo":382,"targetDuration":4,"studyType":24,"phases":383,"briefSummary":384,"conditions":385,"keywords":386,"overallStatus":151,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":144},"100632544","phase-1-safety-and-efficacy-of-nebulized-3d-cultured-human-placental-mesenchymal-stem-cell-derived-extracellular-vesicles-hpmsc-evs-for-idiopathic-pulmonary-fibrosis-100632544","NCT07515066","Safety and Efficacy of Nebulized 3D-cultured Human Placental Mesenchymal Stem Cell-derived Extracellular Vesicles (hPMSC-EVs) for Idiopathic Pulmonary Fibrosis","A Single-center, Open-label, Single and Multiple Dose, Dose-escalation Exploratory Clinical Study to Evaluate the Safety and Efficacy of Nebulized 3D-cultured Human Placental Mesenchymal Stem Cell-derived Extracellular Vesicles (hPMSC-EVs) in Patients With Idiopathic Pulmonary Fibrosis","Inclusion Criteria:\n\n* Age 18 to 75 years, male or female at the time of signing the informed consent form.\n* Confirmed diagnosis of idiopathic pulmonary fibrosis (IPF) in accordance with the 2022 ATS\u002FERS\u002FJRS\u002FALAT clinical criteria.\n* Forced vital capacity (FVC) ≥50% and ≤80% of predicted value, and hemoglobin-corrected diffusing capacity of the lung for carbon monoxide (DLCO) ≥30% and ≤80% of predicted value at screening.\n* Stable dose of antifibrotic therapy (nintedanib, pirfenidone, or nerandomilast) for at least 8 weeks prior to screening.\n* 6-minute walking distance (6MWD) \\>150 meters at screening.\n* Willing to use effective contraception during the study and for 12 months after the last dose of study treatment (for subjects of childbearing potential, including male subjects whose spouses are of childbearing potential).\n* Signed and dated written informed consent form prior to any study-related procedures.\n* Able to comply with all study procedures and scheduled follow-up visits.\n\nExclusion Criteria:\n\n* Prior treatment with stem cell-derived products or extracellular vesicles for any disease.\n* Inability to tolerate nebulized inhalation therapy.\n* History of severe drug allergy or anaphylaxis to any component of the study treatment or nebulization materials.\n* Diagnosis of bronchial asthma or other active respiratory diseases that may interfere with study assessments.\n* Pregnant, breastfeeding, or planning pregnancy within 12 months after the last dose of study treatment.\n* Malignancy within 5 years prior to screening (except adequately treated basal cell carcinoma or cervical carcinoma in situ).\n* Active infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).\n* History of solid organ or hematopoietic stem cell transplantation, or being on the transplant waiting list.\n* Requirement for long-term oxygen therapy for more than 15 hours per day.\n* Severe cardiac, hepatic, renal, or other systemic diseases that, in the investigator's judgment, would compromise study participation or confound study results.\n* Participation in another interventional clinical trial within 3 months prior to screening.","75 Years",{"count":298,"type":23},[219],"This is a single-center, open-label, dose-escalation clinical study to evaluate the safety and efficacy of nebulized 3D-cultured human placental mesenchymal stem cell-derived extracellular vesicles (hPMSC-EVs) in patients with idiopathic pulmonary fibrosis (IPF).\n\nEligible participants will be assigned to one of three dose groups (1.0×10⁹, 2.0×10⁹, or 3.0×10⁹ particles per treatment) using a 3+3 design. All participants will receive nebulized hPMSC-EVs twice daily for 7 consecutive days.\n\nThe main purpose of this study is to assess the safety and tolerability of hPMSC-EVs, including the incidence of adverse events, changes in vital signs, laboratory tests, and immune markers. Secondary objectives include evaluating changes in lung function (FVC, DLCO), 6-minute walking distance, respiratory symptoms (SGRQ score), and chest HRCT findings.\n\nParticipants will undergo screening visits, treatment administration, and follow-up visits up to 12 months after the first dose to monitor safety and efficacy outcomes.",[30],[29,387,388,389],"Extracellular Vesicles","Mesenchymal Stem Cells","Stem Cell Therapy","2026-03-30",{"date":392,"type":41},"2026-04-07",{"date":394,"type":23},"2026-05-01",{"date":396,"type":23},"2029-04-30",{"name":398,"class":143},"Huan Ye",{"id":400,"slug":401,"hasResults":12,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":4,"eligibilityCriteria":405,"healthyVolunteers":12,"sex":18,"minAge":83,"maxAge":4,"enrollmentInfo":406,"targetDuration":4,"studyType":24,"phases":407,"briefSummary":408,"conditions":409,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":411,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":144},"100628805","study-on-the-efficacy-of-quercetin-intake-in-patients-with-fibrotic-interstitial-lung-diseases-100628805","NCT07466420","Study on the Efficacy of Quercetin Intake in Patients With Fibrotic Interstitial Lung Diseases.","Study on the Efficacy of Quercetin Intake in Patients With Idiopathic Pulmonary Fibrosis and Non-Idiopathic Pulmonary Fibrosis. A Two-arm, Prospective Randomized Controlled Clinical Trial.","Inclusion Criteria:\n\n* Patients with an established diagnosis of IPF and Fibrotic ILD and will be eligible to participate in the study.\n* The use of the approved standard of care antifibrotic therapy, either nintedanib or pirfenidone, and immunosuppressive therapy will be allowed as standard of care.\n\nExclusion Criteria:\n\n* Subjects with a result of FeNO\\>25 ppb will be excluded from the study to ensure that no other pulmonary diseases, such as asthma, are present.\n* Patients who do not initiate quercetin within the first week after their baseline visit.",{"count":187,"type":23},[109],"Fibrotic interstitial lung diseases (F-ILDs), including both idiopathic pulmonary fibrosis (IPF) and non-IPF, are chronic and progressive lung diseases characterized by excessive scarring of lung tissue, leading to declining lung function, respiratory failure, and high mortality, despite the currently approved antifibrotic treatment. While its exact cause remains unknown, pulmonary fibrosis is strongly linked to aging, genetic predisposition, environmental factors, and cellular senescence. Ongoing research aims to identify reliable biomarkers and develop targeted treatments to enhance patient outcomes.\n\nThis randomized controlled trial will examine the effects of quercetin supplementation (500 mg\u002Fday for two 12-week cycles, with one 8-week washout periods) on telomere length, senescence-associated secretory phenotype (SASP) factors, and lung function in patients with IPF and F-ILDs. A total of 100 patients will be recruited, with half receiving quercetin (despite their standard of care therapy) and the other half receiving standard care (SOC). Primary outcomes will include changes in telomere length, SASP protein levels (IL-6, MMPs), fractional exhaled nitric oxide (FeNO), spirometry (FVC decline), and oscillometry measurements. Additionally, quality of life will be assessed using the L-IPF Questionnaire.\n\nThis study aims to explore quercetin's potential to reduce fibrosis, decrease inflammation, and improve lung function in F-ILDs, offering new insights into potential novel strategies for F-ILD management.",[410,30,89],"Fibrotic Interstitial Lungs Diseases",{"date":412,"type":41},"2026-03-12",{"date":414,"type":41},"2026-01-26",{"date":416,"type":23},"2029-01-31",{"name":418,"class":143},"Katerina M. Antoniou",{"id":420,"slug":421,"hasResults":12,"nctId":422,"briefTitle":423,"officialTitle":424,"acronym":4,"eligibilityCriteria":425,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":426,"targetDuration":4,"studyType":24,"phases":428,"briefSummary":429,"conditions":430,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":144},"100628689","phase-3-a-adaptive-design-clinical-trial-to-evaluate-the-efficacy-and-safety-of-tdi01-suspension-in-the-treatment-of-idiopathic-pulmonary-fibrosis-ipf-100628689","NCT07464912","A Adaptive Design Clinical Trial to Evaluate the Efficacy and Safety of TDI01 Suspension in the Treatment of Idiopathic Pulmonary Fibrosis (IPF)","A Multicentre, Randomised, Double-blind, Placebo-controlled, Adaptive Design Clinical Trial to Evaluate the Efficacy and Safety of TDI01 Suspension in the Treatment of Idiopathic Pulmonary Fibrosis (IPF)","Inclusion Criteria:\n\n1. Diagnosed with IPF\n\n   1. Confirmed diagnosis before screening: Diagnosis was made according to the 2022 clinical practice guideline principles of the American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), and Latin American Thoracic Society (ALAT) (see Appendix 1), confirmed by the investigators based on chest high-resolution CT (HRCT) performed within 12 months before Visit 1, and surgical lung biopsy or transbronchial lung cryobiopsy (if available);\n   2. Reconfirmation of IPF diagnosis at screening: And before Visit 2, the independent imaging review panel of experts reviewed and confirmed that the HRCT (HRCT within 3 months before randomisation in the same site was accepted) is consistent with a clinical diagnosis of usual interstitial pneumonia (UIP) or probable UIP for IPF. For subjects with an HRCT finding of \"indeterminate for UIP\", if a local (previous) surgical lung biopsy or transbronchial lung cryobiopsy has been performed, the pathological slides must be submitted for central review and assessment. If the histopathological features show \"UIP\" or \"probable UIP\", the clinical diagnosis of IPF can be confirmed;\n2. Voluntarily participates in this clinical study and signs the informed consent form before the start of the study;\n3. Age is 40-80 years (inclusive of 40 and 80 years) at the time of signing the informed consent form, regardless of sex;\n4. Female or male subjects of childbearing potential agree and commit to using highly effective contraceptive measures (see Appendix 8 in 19.8) from the time of signing the informed consent form until 90 days after the last dose of the investigational medicinal product;\n5. Stable disease for at least 8 weeks prior to Visit 1. Patients must meet one of the following two criteria:\n\n   1. Did not receive treatment with nintedanib and\u002For pirfenidone for at least 8 weeks prior to Visit 1 (including patients not treated with nintedanib\u002Fpirfenidone and those who had failed treatment with nintedanib\u002Fpirfenidone);\n   2. Or have been receiving a stable\\* regimen of nintedanib or pirfenidone for at least 12 weeks prior to Visit 1, and plan to continue receiving this background therapy stably after randomisation \\[\\*stable treatment is defined as the patient being able to generally tolerate continuous treatment with an unchanged dose of pirfenidone (400 mg TID and above) or nintedanib (100 mg BID and above)\\];\n6. At screening and baseline, forced expiratory volume in one second (FEV1)\u002FFVC ratio ≥ 0.70;\n7. At screening and baseline, FVC% of predicted is greater than 50% (inclusive);\n8. DLco (Hb-corrected) percent of predicted normal value is greater than 30% (inclusive) at screening and at baseline;\n9. Active bacterial, viral, parasitic, or fungal infection requiring systemic treatment within 4 weeks prior to screening, but the infection is judged by the investigator to be cured during the screening period;\n10. In the investigator's assessment, the subject is willing and able to comply with protocol requirements and attend visits.\n\nExclusion Criteria:\n\nInclusion criteria\n\nSubjects who meet each of the following criteria will be allowed to participate in this study:\n\n1. Diagnosed with IPF\n\n   1. Confirmed diagnosis before screening: Diagnosis was made according to the 2022 clinical practice guideline principles of the American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), and Latin American Thoracic Society (ALAT) (see Appendix 1), confirmed by the investigators based on chest high-resolution CT (HRCT) performed within 12 months before Visit 1, and surgical lung biopsy or transbronchial lung cryobiopsy (if available);\n   2. Reconfirmation of IPF diagnosis at screening: And before Visit 2, the independent imaging review panel of experts reviewed and confirmed that the HRCT (HRCT within 3 months before randomisation in the same site was accepted) is consistent with a clinical diagnosis of usual interstitial pneumonia (UIP) or probable UIP for IPF. For subjects with an HRCT finding of \"indeterminate for UIP\", if a local (previous) surgical lung biopsy or transbronchial lung cryobiopsy has been performed, the pathological slides must be submitted for central review and assessment. If the histopathological features show \"UIP\" or \"probable UIP\", the clinical diagnosis of IPF can be confirmed;\n2. Voluntarily participates in this clinical study and signs the informed consent form before the start of the study;\n3. Age is 40-80 years (inclusive of 40 and 80 years) at the time of signing the informed consent form, regardless of sex;\n4. Female or male subjects of childbearing potential agree and commit to using highly effective contraceptive measures (see Appendix 8 in 19.8) from the time of signing the informed consent form until 90 days after the last dose of the investigational medicinal product;\n5. Stable disease for at least 8 weeks prior to Visit 1. Patients must meet one of the following two criteria:\n\n   1. Did not receive treatment with nintedanib and\u002For pirfenidone for at least 8 weeks prior to Visit 1 (including patients not treated with nintedanib\u002Fpirfenidone and those who had failed treatment with nintedanib\u002Fpirfenidone);\n   2. Or have been receiving a stable\\* regimen of nintedanib or pirfenidone for at least 12 weeks prior to Visit 1, and plan to continue receiving this background therapy stably after randomisation \\[\\*stable treatment is defined as the patient being able to generally tolerate continuous treatment with an unchanged dose of pirfenidone (400 mg TID and above) or nintedanib (100 mg BID and above)\\];\n6. At screening and baseline, forced expiratory volume in one second (FEV1)\u002FFVC ratio ≥ 0.70;\n7. At screening and baseline, FVC% of predicted is greater than 50% (inclusive);\n8. DLco (Hb-corrected) percent of predicted normal value is greater than 30% (inclusive) at screening and at baseline;\n9. Active bacterial, viral, parasitic, or fungal infection requiring systemic treatment within 4 weeks prior to screening, but the infection is judged by the investigator to be cured during the screening period;\n10. In the investigator's assessment, the subject is willing and able to comply with protocol requirements and attend visits.\n\nExclusion criteria\n\nSubjects who meet any of the following criteria will not be allowed to participate in this study:\n\n1. Other known causes of interstitial lung disease, such as home or occupational environmental exposure, connective tissue disease, drugs, etc.;\n2. With other clinically significant lung diseases besides IPF (such as asthma, COPD or significant airways obstruction \\[FEV1\u002FFVC ratio \\\u003C0.7\\], hypersensitivity pneumonitis, eosinophilic pneumonia, etc.);\n3. Patients who are planning to undergo a lung transplant within 12 months after screening;\n4. Active infection tuberculosis within 12 months prior to screening, or any active bacterial, viral, parasitic, or fungal infection requiring systemic treatment during the screening period;\n5. Subjects whose IPF condition is assessed by the investigator as unstable at screening, or who have had an acute exacerbation of IPF within 8 weeks before screening and\u002For during the screening period;\n6. Use of any of the following treatments within 4 weeks prior to randomisation:\n\n   1. IPF therapeutic drugs, unstable treatment with nintedanib or pirfenidone, \\> 15 mg\u002Fd prednisone or equivalent doses of other glucocorticoids, use of immunomodulatory drugs other than glucocorticoids for respiratory\u002Fpulmonary reasons; \\[Stable treatment is defined as the individual patient being able to generally tolerate continuous treatment with an unchanged dose of pirfenidone (400 mg TID and above) or nintedanib (100 mg BID and above) for at least 8 weeks\\];\n   2. Strong CYP3A4 inhibitors (including but not limited to ritonavir, clarithromycin, idelalisib, etc., see Appendix 4 for details);\n   3. Narrow therapeutic window substrates of CYP2C9 (such as warfarin, tolbutamide, and phenytoin) and sensitive substrates of P-gp (such as digoxin);\n   4. ROCK2 inhibitor (belumosudil);\n7. History of malignant tumour within 5 years prior to screening (except for patients with appropriately treated skin basal cell carcinoma or squamous cell carcinoma of skin in situ or in situ cancer of cervix);\n8. Moderate to severe hepatic insufficiency (Child-Pugh Class B or C) before screening;\n9. Laboratory test results exceeding any of the following criteria at screening and at baseline: Bilirubin total \\>1.5×ULN or AST\u002FALT\\>2×ULN, serum CK\\>1.5×ULN;\n10. Uncontrolled hepatitis B virus infection (HBsAg positive and HBV-DNA ≥ 102 IU\u002FmL) or hepatitis C virus infection (anti-HCV and HCV-RNA positive) at screening;\n11. With history of unstable or worsening cardiac disorder within 6 months prior to screening, including but not limited to the following:\n\n    1. Unstable angina;\n    2. Myocardial infarction;\n    3. CCF requiring hospitalisation or NYHA Class III\u002FIV;\n    4. Uncontrolled severe arrhythmia.\n12. Family history of long QT syndrome or sudden death, or clinically significant abnormalities on ECG at screening and baseline, including but not limited to: QTcF interval \\> 470 ms (female) or \\>450 ms (male), fibrillation atrial or flutter atrial, second-degree or third-degree AV block, left bundle branch block;\n13. SBP \\>160 mmHg or DBP \\>100 mmHg at screening and baseline (to be measured after at least 5 minutes of rest, and confirmed by one re-check to still meet this standard);\n14. Cerebrovascular event leading to hospitalisation within 12 months prior to screening, including but not limited to hematencephalon, subarachnoid haemorrhage, stroke, etc.;\n15. Creatinine clearance (CLcr) \\\u003C50 mL\u002Fmin at screening and baseline, calculated using the Cockcroft-Gault formula: \\[140 - age (years)\\] \\[weight (kg)\\] × (0.85, if female) \u002F \\[72 × blood creatinine (mg\u002FdL)\\];\n16. Unable to complete the six minute walk distance (6MWD) or pulmonary function test (PFT);\n17. History of smoking within 3 months prior to screening or unwillingness to practice cessation of smoking during the study;\n18. Frequent alcohol use \\[more than 21 units of alcohol per week (1 unit = 360 mL beer or 45 mL of 40% alcohol or 150 mL wine)\\] within 6 months before screening, or unwillingness to reduce alcohol intake to within 21 units during the study;\n19. History of drug abuse within 6 months prior to screening;\n20. Pregnancy or lactation;\n21. Human immunodeficiency virus (HIV) antibody test result is non-negative at screening;\n22. Allergy to any component of TDI01 suspension;\n23. The last dose in other clinical studies was administered within 3 months or 5 half-lives prior to screening, whichever is longer;\n24. Major surgery (general anaesthesia surgery) within 3 months prior to screening, or planned surgery during the study period that is considered by the investigator to affect the judgment of study endpoints;\n25. The investigator assesses that the subject has an unstable state of other systemic or organ diseases, which may impair their safety or compliance, affect drug absorption, or lead to other conditions that prevent them from completing the study assessments.",{"count":427,"type":23},508,[309],"This study is a multicentre, randomised, double-blind, placebo-controlled, adaptive design clinical trial to evaluate the efficacy and safety of TDI01 suspension in the treatment of idiopathic pulmonary fibrosis (IPF). The study will be conducted in China and divided into two stages, both of which are multicentre, randomised, double-blind, placebo-controlled studies. Stage 1 aims to evaluate the efficacy and safety of TDI01 suspension compared to the placebo group in the treatment of IPF patients, and Stage 2 aims to further confirm the efficacy and safety of TDI01 suspension compared to the placebo group in the treatment of IPF patients.",[30],{"date":432,"type":41},"2026-03-11",{"date":434,"type":41},"2025-12-24",{"date":436,"type":23},"2029-12-30",{"name":438,"class":48},"Beijing Tide Pharmaceutical Co., Ltd",{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":4,"eligibilityCriteria":445,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":446,"targetDuration":4,"studyType":24,"phases":448,"briefSummary":450,"conditions":451,"keywords":4,"overallStatus":151,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":453,"startDateStruct":455,"completionDateStruct":457,"leadSponsor":459,"locationsCount":144},"100620618","early-phase-1-treatment-of-idiopathic-pulmonary-fibrosis-ipf-by-regend007-cell-therapy-100620618","NCT07359963","Treatment of Idiopathic Pulmonary Fibrosis (IPF) by REGEND007 Cell Therapy","An Exploratory Clinical Study on the Intravenous Infusion of REGEND007 (Generic Airway Basal Layer Stem Cell Preparation) for the Treatment of Idiopathic Pulmonary Fibrosis (IPF).","Inclusion Criteria:\n\n* Gender is not restricted. When signing the informed consent form, the age should be between 40 and 80 years old (inclusive of the boundary value).\n* Diagnosed with idiopathic pulmonary fibrosis (IPF).\n* During the screening process, the six-minute walk test should be ≥ 150 meters and \\\u003C 600 meters; or the lung function FVC should be \\> 30% of the predicted value.\n* Voluntarily sign the informed consent form, be able to cooperate with the completion of research-related procedures and examinations, and be able to comprehensively describe or record the changes in the condition.\n\nExclusion Criteria:\n\n* Female subjects who are pregnant, breastfeeding, or planning to become pregnant within one year after using this product; or male subjects whose partner is planning to become pregnant.\n* Subjects selected during the screening whose estimated survival period is less than one year.\n* Subjects selected during the screening who have a current or past history of malignant tumors (excluding malignant tumors with a disease-free survival of more than five years and judged by the researcher to have a relatively mild invasiveness, such as non-melanoma skin cancer, invasive cervical cancer, bladder cancer, thyroid cancer, and breast cancer, etc.).\n* Subjects selected within 4 weeks before diagnosis of pneumonia (including bacterial, fungal or viral pneumonia).\n* Subjects selected within 4 weeks before an acute exacerbation of IPF.\n* Subjects selected within 4 weeks before having one or more results reported by pathogenological or serological tests (nucleic acid, antigen, virus culture, specific IgG antibody levels) indicating novel coronavirus infection, or suspected novel coronavirus infection (manifesting symptoms such as fever, headache, fatigue, joint pain, runny nose, sore throat, and persistent cough, and the disease course is consistent with the prevalent strain).\n* Subjects selected within 4 weeks before having a history of invasive or non-invasive mechanical ventilation.\n* Subjects selected during the screening who have active pulmonary tuberculosis, poorly controlled bronchial asthma, acute pulmonary embolism, severe pulmonary hypertension \\[cardiac ultrasound examination \\> 70 mmHg\\], etc.\n* Subjects selected within 6 months before having a serious non-pulmonary systemic disease and judged by the researcher as not suitable to participate in this study, such as diabetes with ketoacidosis or hyperosmolar coma, acute myocardial infarction, unstable angina pectoris, NYHA heart failure grade III\u002FIV, stroke, liver cirrhosis with severe liver dysfunction, severe renal insufficiency, etc.\n* Subjects selected during the screening who have severe anemia, or controlled poorly granulocytopenia or thrombocytopenia.\n* Subjects selected during the screening who have a history of suicide risk, psychiatric history or epilepsy history.\n* Subjects selected during the screening who have severe malnutrition.\n* Subjects selected during the screening whose 12-lead electrocardiogram shows severe arrhythmias (such as ventricular tachycardia, supraventricular tachycardia, atrial fibrillation, atrial flutter, etc.) or second-degree and above conduction abnormalities of the heart.\n* Subjects selected within 4 weeks before participating in other clinical trials with intervention measures or using other biological agents for treatment.\n* Researchers, collaborating researchers, research coordinators, researchers participating in the study or employees of the research center or their family members.\n* Subjects selected during the screening who the researcher considers unsuitable to participate in the trial (increasing the risk for the subjects or interfering with the clinical trial).",{"count":447,"type":23},12,[449],"EARLY_PHASE1","This study is a prospective, single-arm, dose-escalation exploratory clinical trial to investigate the safety, tolerability and preliminary efficacy of REGEND007 stem cell preparation administered by intravenous infusion in the treatment of idiopathic pulmonary fibrosis (IPF), with a follow-up period of 12 weeks.",[30],"2026-01-13",{"date":454,"type":41},"2026-01-22",{"date":456,"type":23},"2026-02-15",{"date":458,"type":23},"2027-06-15",{"name":460,"class":48},"Regend Therapeutics",{"id":462,"slug":463,"hasResults":12,"nctId":464,"briefTitle":465,"officialTitle":465,"acronym":466,"eligibilityCriteria":467,"healthyVolunteers":12,"sex":18,"minAge":83,"maxAge":4,"enrollmentInfo":468,"targetDuration":4,"studyType":188,"phases":4,"briefSummary":470,"conditions":471,"keywords":472,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":477,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":144},"100618476","a-pilot-study-to-assess-body-mass-composition-measurement-using-bia-and-muscle-ultrasound-in-ipf-and-ppf-patients-on-anti-fibrotic-medications-100618476","NCT07332117","A Pilot Study to Assess Body Mass Composition Measurement Using BIA and Muscle Ultrasound in IPF and PPF Patients on Anti-fibrotic Medications","AF-BMC","Inclusion Criteria:\n\n* A diagnosis of Idiopathic pulmonary fibrosis or progressive pulmonary fibrosis\n* Newly commencing anti-fibrotic medication (either nintedanib or pirfenidone)\n* Subject aged \\> 18 years\n* Able to willingly give consent\n\nExclusion Criteria:\n\n* Co-morbidities currently requiring enteral feeding\n* Weight loss \\> 10% in preceding 3-6 months\n* Significant musculoskeletal issues that may impact muscle mass\n* End of life care (expected \\\u003C 6 weeks left to live)\n* Previous anti-fibrotic use\n* Currently on \\> Prednisolone 10mg daily\n* Presence of implantable cardioverter defibrillator (ICD) or permanent pacemaker (PPM)\n* Heart failure\n* Pregnancy",{"count":469,"type":23},30,"To assess the impact on body mass composition from anti-fibrotic medications used in fibrotic lung disease by using BIA and muscle ultrasound",[30,89],[473,474,475],"bioimpedance analysis","muscle ultrasound","body composition","2025-12-31",{"date":478,"type":41},"2026-01-12",{"date":480,"type":41},"2025-09-09",{"date":482,"type":23},"2026-04",{"name":484,"class":143},"Royal Brompton & Harefield NHS Foundation Trust",{"id":486,"slug":487,"hasResults":12,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":491,"eligibilityCriteria":492,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":493,"targetDuration":4,"studyType":24,"phases":495,"briefSummary":496,"conditions":497,"keywords":498,"overallStatus":151,"whyStopped":4,"lastUpdateSubmitDate":502,"lastUpdatePostDateStruct":503,"startDateStruct":504,"completionDateStruct":505,"leadSponsor":507,"locationsCount":4},"100614823","phase-3-trial-to-evaluate-the-efficacy-and-safety-of-lyt-100-deupirfenidone-compared-to-pirfenidone-in-adults-with-idiopathic-pulmonary-fibrosis-ipf-100614823","NCT07284602","Trial to Evaluate the Efficacy and Safety of LYT-100 (Deupirfenidone) Compared to Pirfenidone in Adults With Idiopathic Pulmonary Fibrosis (IPF)","A Randomized, Double-Blind, Head-to-Head Phase 3 Trial to Evaluate the Efficacy and Safety of LYT-100 (Deupirfenidone) Compared to Pirfenidone at 52 Weeks in Adults With Idiopathic Pulmonary Fibrosis (SURPASS-IPF)","SURPASS-IPF","Inclusion Criteria:\n\n* Is ≥40 years of age at the time of informed consent.\n* Meets the diagnostic criteria of IPF American Thoracic Society (ATS)\u002FEuropean Respiratory Society (ERS)\u002FJapanese Respiratory Society (JRS)\u002FLatin American Thoracic Society (ALAT) 2022 guidelines.\n* Has a maximum time from initial IPF diagnosis of 7 years.\n* Has no prior exposure to pirfenidone or LYT-100, and has \\\u003C12 months of prior exposure to nintedanib or any other approved antifibrotic therapies.\n* Has definite or probable unusual interstitial pneumonia (UIP) on HRCT, performed within 12 months prior to Visit 1 and confirmed by the central reader.\n* Has an FVC ≥45% of predicted normal at Visit 1.\n\nExclusion Criteria:\n\n* Has, in the opinion of the Investigator, significant clinical worsening of IPF between Visit 1 and Visit 2.\n* Has been hospitalized within 3 months prior to Visit 1 for acute exacerbation of IPF or other significant respiratory complication.\n* Has prebronchodilator forced expiratory volume in 1 second (FEV1)\u002FFVC \\\u003C0.7 at Visit 1.\n* Has a greater extent of emphysema vs fibrosis on the most recent HRCT scan as confirmed by the central reader.\n* Has a diagnosis of any condition that could be an explanation for interstitial lung disease (ILD).\n* Has a major extrapulmonary condition that could affect spirometry.\n* Has a current diagnosis of other relevant respiratory disorders.\n* Has significant pulmonary hypertension (PH).\n* Has had a lung transplant.\n* Has cardiovascular disease.\n* Has underlying chronic liver disease\u002Fimpairment.\n* Has relevant chronic or acute infections including active viral hepatitis or poorly controlled HIV.\n* Has had any major surgical procedures performed within 6 weeks prior to Visit 1 or is planning to have a major surgical procedure during the study.\n* Has any documented active or suspected malignancy or history of malignancy within 5 years prior to Visit 1.\n* Has any of the following laboratory abnormalities at Visit 1:\n\n  * Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \\>1.5 × upper limit of normal (ULN).\n  * Total bilirubin \\>1.5 × ULN. Exceptions may be made on a case-by-case basis for participants with Gilbert's syndrome in consultation with the Medical Monitor.\n  * Creatinine clearance \\\u003C30 mL\u002Fmin calculated by Cockcroft-Gault formula.\n* Is currently taking prednisone at a steady dose \\>10 mg\u002Fday or equivalent (a steady dose ≤10 mg\u002Fday is not exclusionary but the individual must be on a stable dose for at least 30 days prior to Visit 2).\n* Use of any tobacco or combustible cannabis products within 3 months prior to Visit 1 or is unable to refrain from use during the trial.\n* Has known symptoms of dysphagia, difficulty in swallowing capsules or tablets, or has had a total gastrectomy.\n* Is currently enrolled in another clinical study (except observational\u002Fregistry or biobank studies) or has used any investigational drug or device within 90 days prior to Visit 1.\n* Has ever received stem cell therapy for the treatment of pulmonary fibrosis.\n* Is currently pregnant, breastfeeding, or is planning to become pregnant during the study.\n* Has had any prior exposure to LYT-100 or pirfenidone (even one dose).",{"count":494,"type":23},1100,[309],"This is a study for adults with a lung disease called idiopathic pulmonary fibrosis. The main purpose of this study is to look at how well deupirfenidone improves lung function and how safe it is for people with idiopathic pulmonary fibrosis (IPF) when compared with pirfenidone. Participants may have been treated with an approved antifibrotic drug for up to a year in the past, but they cannot be on background antifibrotic treatment during this study. Participants will be randomly assigned (meaning by chance) to take either deupirfenidone or pirfenidone 3 times a day, and neither a participant nor their study team will know which study drug participants are on. Participants will be in the study for up to approximately 3 years. During the first year, participants visit the study site up to ten times and afterwards they visit the site every three months. All participants will remain on blinded study drug until the last participant has completed Week 52 Visit. They will have lung function tests, a check of their health, and will tell the study team about any unfavorable effects.",[30],[29,121,119,499,500,501],"Deupirfenidone","Pirfenidone","Lung Disease","2025-12-18",{"date":294,"type":41},{"date":482,"type":23},{"date":506,"type":23},"2029-07",{"name":508,"class":48},"PureTech",{"id":510,"slug":511,"hasResults":12,"nctId":512,"briefTitle":513,"officialTitle":514,"acronym":4,"eligibilityCriteria":515,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":516,"targetDuration":4,"studyType":24,"phases":517,"briefSummary":518,"conditions":519,"keywords":520,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":523,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":531},"100573564","phase-2-sb17170-phase-2-trial-in-ipf-patients-100573564","NCT06747923","SB17170 Phase 2 Trial in IPF Patients","A Randomized, Double-blind, Placebo-controlled, Parallel, Multicenter, Exploratory Phase IIa Clinical Trial to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Properties of SB17170 in Idiopathic Pulmonary Fibrosis (IPF) Patients.","Inclusion Criteria:\n\n1. Adult male\u002Ffemale 40 years or older at the time of obtaining informed consent\n2. Patients diagnosed with idiopathic pulmonary fibrosis who meet the following criteria:\n\n   * Patients with idiopathic pulmonary fibrosis who are confirmed by chest High-Resolution Computed Tomography (HRCT) scan\n   * Patients with Usual Interstitial Pneumonia (UIP) or probable UIP HRCT pattern consistent with a diagnosis of idiopathic pulmonary fibrosis confirmed through central reading of chest HRCT before the baseline visit\n3. Patients with a history of idiopathic pulmonary fibrosis treatment who meet the defined criteria\n4. Patients with Forced Vital Capacity (FVC) ≥ 45% of the normal predicted value at the screening visit\n5. Patients meeting pulmonary function test criteria at the screening visit\n6. Patients who have received the explanation of this clinical trial and voluntarily agreed and signed the informed consent form\n\nExclusion Criteria:\n\n1. When there is a primary disease showing UIP patterns (rheumatoid arthritis-related interstitial lung disease, connective tissue disease-related interstitial lung disease, etc.) and\u002For other clinically significant lung abnormalities\n2. Patients with confirmed acute exacerbation of IPF within 6 months prior to screening and\u002For during the screening period\n3. Patients with lower respiratory tract infections requiring antibiotic treatment\n4. Patients who underwent major surgery within 3 months before screening or have major surgery planned during the clinical trial\n5. Patients with a history of malignancy or documented evidence of active or suspected malignancy within 5 years prior to screening\n6. Patients with evidence of active infection\n7. Patients with the following cardiovascular and cerebrovascular diseases at the time of screening:\n\n   * Severe hypertension within 3 months\n   * Myocardial infarction or unstable angina within 6 months\n   * History of thrombotic events within 6 months\n   * Diagnosis of heart failure within 6 months\n8. Patients with pulmonary hypertension\n9. Patients who are unable to take drugs orally or have a history of major gastrointestinal surgery or pathological findings that may affect the absorption of the investigational product\n10. Patients with Human Immunodeficiency Virus (HIV) infection or active hepatitis B or C",{"count":469,"type":23},[26],"This clinical trial is a 2:2:1 randomized, double-blind, placebo-controlled, parallel group, exploratory phase II trial. The main objective of this trial is to compare and evaluate change in FVC compared to placebo by administering SB17170 to moderate to severe patients with IPF. This clinical trial treatment involves administering SB17170 or placebo for 12 weeks.",[121,29,30],[521],"HMGB1","2025-11-17",{"date":524,"type":41},"2025-11-19",{"date":526,"type":41},"2025-01-27",{"date":528,"type":23},"2026-10-31",{"name":530,"class":48},"SPARK Biopharma",5,{"id":533,"slug":534,"hasResults":12,"nctId":535,"briefTitle":536,"officialTitle":536,"acronym":4,"eligibilityCriteria":537,"healthyVolunteers":214,"sex":18,"minAge":83,"maxAge":4,"enrollmentInfo":538,"targetDuration":4,"studyType":188,"phases":4,"briefSummary":540,"conditions":541,"keywords":547,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":559,"startDateStruct":561,"completionDateStruct":563,"leadSponsor":564,"locationsCount":144},"100192097","collection-of-airway-blood-andor-urine-specimens-from-subjects-for-research-studies-100192097","NCT01776398","Collection of Airway, Blood and\u002For Urine Specimens From Subjects for Research Studies","Inclusion Criteria:\n\nGroup 1.1 - HEALTHY VOLUNTEER RESEARCH SUBJECTS (Healthy as defined by those not having lung disease and inclusive of: all races, ethnicities, sex, HIV status, smoking status and multiple birth status, etc., within the general population. Smoking status is defined for individuals that may use any of the following: cigarettes, pipes, E-cigarettes, waterpipe, shisha, etc.):\n\n* All study subjects should be able to provide informed consent\n* Males or females ages 18 years and older\n* Must provide HIV informed consent\n\nGroup 1.2 - VOLUNTEER RESEARCH SUBJECTS WITH LUNG DISEASE (As defined by those having lung disease or symptoms of lung disease and inclusive of: all races, ethnicities, sex, HIV status, smoking status and multiple birth status, etc., within the general population. Smoking status is defined for individuals that may use any of the following: cigarettes, pipes, E-cigarettes, waterpipe, shisha, etc.):\n\n* Must provide informed consent\n* Males and females age 18 years and older\n* Lung disease proven by at least one of the following: symptoms consistent with pulmonary disease; (2) chest X-rays consistent with lung disease; (3) pulmonary function tests consistent with lung disease; (4) lung biopsy consistent with lung disease; (5) family history of lung disease; and\u002For (6) diseases of organs with known association with lung disease\n* Must provide HIV informed consent\n\nAdditional Inclusion criteria for CF subjects:\n\n• All CF subjects will be homozygous for the ΔF508 mutation, with mild-moderate lung disease as defined by FEV1 ≥ 50%\n\nGroup 2 - WCMC\u002FNYPH CLINICAL PATIENTS\n\n* Must provide informed consent\n* Males and females, age 18 years and older\n* Lung disease proven by at least one of the following: (1) symptoms consistent with pulmonary disease; (2) chest X-rays consistent with lung disease; (3) pulmonary function tests consistent with lung disease; (4) lung biopsy consistent with lung disease; (5) family history of lung disease; (6) diseases of organs with known association with lung disease, and (7) individuals with the blood eosinophil levels of 5% or greater.\n\nGroup 3 - PCNY CLINICAL PATIENTS VOLUNTEER RESEARCH SUBJECTS WITH LUNG DISEASE\n\n* Must provide informed consent\n* Males and females, age 18 years and older\n* Lung disease proven by at least one of the following: symptoms consistent with pulmonary disease; (2) chest X-rays consistent with lung disease; (3) pulmonary function tests consistent with lung disease; (4) lung biopsy consistent with lung disease; (5) family history of lung disease; and (6) diseases of organs with known association with lung disease\n\nExclusion Criteria:\n\nGroup 1.1 - HEALTHY VOLUNTEER RESEARCH SUBJECTS\n\n* Individuals not deemed in good overall health by the investigator during screening visits and\u002For prior to the bronchoscopy will not be accepted into the study.\n* Individuals with history of chronic lung disease, including asthma or with recurrent or recent (within three months) acute pulmonary disease will not be accepted into the study.\n* Individuals with allergies to atropine or any local anesthetic will not be accepted into the study.\n* Individuals with allergies to pilocarpine, isoproterenol, terbutaline, atropine or aminophylline will not be accepted into the study.\n* Females who are pregnant or nursing will not be accepted into the study\n\nGroup 1.2 - VOLUNTEER RESEARCH SUBJECTS WITH LUNG DISEASE\n\n* Any history of allergies to xylocaine, lidocaine, versed, valium, atropine, pilocarpine, isoproterenol, terbutaline, aminophylline, or any local anesthetic will not be included in the study\n* Individuals deemed unable to complete the bronchoscopy due to health concerns by the investigator.\n* Females who are pregnant or nursing\n\nAdditional Exclusion criteria for CF subjects:\n\n* Experienced a recent (≤ 8 weeks) pulmonary exacerbation of their disease\n\nGroup 2 - WCMC\u002FNYPH CLINICAL PATIENTS\n\n* Patient refuses consent\n\nGroup 3 - PCNY CLINICAL PATIENTS\n\n* Patient refuses consent",{"count":539,"type":23},2000,"The purpose of this study is to obtain biologic materials from the blood, airways and\u002For urine of normal individuals and individuals with lung disease. The normal are used to establish a set of normal ranges for various parameters. These provide control information when compared to individuals with various pulmonary diseases, and will help in understanding of the etiology and pathogenesis of various lung diseases. The underlying hypothesis is that the pathologic morphological changes in the airway epithelium must be preceded by changes in the gene expression pattern of the airway epithelium and potentially in macrophages.",[542,543,544,30,545,546],"Chronic Obstructive Pulmonary Disease (COPD)","Smoking","Smoking Cessation","Rheumatoid Arthritis-Associated Interstitial Lung Disease","Scleroderma-Associated Interstitial Lung Disease (SSC-ILD)",[548,549,550,551,543,552,553,554,121,555,556,29,545,557],"COPD","Chronic Obstructive Pulmonary Disease","Lung disease","Emphysema","Healthy Smoker","Smoker","Non-smoker","RA-ILD","SSC-ILD","Scleroderma-Associated Interstitial Lung Disease","2025-11-12",{"date":560,"type":41},"2025-11-14",{"date":562,"type":41},"2012-08-29",{"date":45,"type":23},{"name":565,"class":143},"Weill Medical College of Cornell University",{"id":567,"slug":568,"hasResults":12,"nctId":569,"briefTitle":570,"officialTitle":571,"acronym":4,"eligibilityCriteria":572,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":573,"targetDuration":4,"studyType":24,"phases":575,"briefSummary":576,"conditions":577,"keywords":578,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":584,"lastUpdatePostDateStruct":585,"startDateStruct":586,"completionDateStruct":588,"leadSponsor":590,"locationsCount":447},"100514245","phase-2-study-evaluating-ins018055-administered-orally-to-subjects-with-idiopathic-pulmonary-fibrosis-100514245","NCT05975983","Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis","A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis (IPF)","Inclusion Criteria:\n\n1. Male or female patients aged ≥40 years based on the date of the written informed consent form\n2. Diagnosis of IPF as defined by American Thoracic Society\u002FEuropean Respiratory Society\u002FJapanese Respiratory Society\u002FLatin American Thoracic Association guidelines\n3. In a stable condition and suitable for study participation based on the results of medical history, physical examination, vital signs, 12-lead ECG, and laboratory evaluation\n4. Meeting all of the following criteria during the screening period:\n\n   1. FVC ≥40% predicted normal\n   2. DLCO corrected for Hgb ≥25% and \\\u003C80% predicted normal\n   3. Forced Expiratory Volume in the first second\u002FFVC (FEV1\u002FFVC) ratio \\>0.7 based on pre-bronchodilator value\n\nExclusion Criteria:\n\n1. Acute IPF exacerbation within 4 months prior to Visit 1 and\u002For Day 1, as determined by the investigator\n2. Patients who are unwilling to refrain from smoking within 3 months prior to screening and until the end of the study\n3. Female patients who are pregnant or nursing\n4. Abnormal ECG findings",{"count":574,"type":23},40,[26],"The purpose of this revised Phase IIa study is to demonstrate safety of INS018\\_055 over 12 weeks in adults with Idiopathic Pulmonary Fibrosis (IPF).",[30],[119,29,579,580,581,582,583],"Fibrosis","Pathologic Processes","Lung Diseases, Interstitial","Lung Diseases","Respiratory Tract Diseases","2025-11-10",{"date":558,"type":41},{"date":587,"type":41},"2024-02-08",{"date":589,"type":23},"2026-02-28",{"name":591,"class":48},"InSilico Medicine Hong Kong Limited",{"id":593,"slug":594,"hasResults":12,"nctId":595,"briefTitle":596,"officialTitle":597,"acronym":598,"eligibilityCriteria":599,"healthyVolunteers":12,"sex":18,"minAge":83,"maxAge":4,"enrollmentInfo":600,"targetDuration":4,"studyType":24,"phases":602,"briefSummary":603,"conditions":604,"keywords":4,"overallStatus":151,"whyStopped":4,"lastUpdateSubmitDate":605,"lastUpdatePostDateStruct":606,"startDateStruct":608,"completionDateStruct":610,"leadSponsor":612,"locationsCount":4},"100606746","motivational-interviewing-program-on-the-self-care-in-idiopathic-pulmonary-fibrosis-100606746","NCT07179562","Motivational Interviewing Program on the Self-Care in Idiopathic Pulmonary Fibrosis","Effectiveness of a Motivational Interviewing Program on the Self-Care Levels of Patients With Idiopathic Pulmonary Fibrosis","MI-IPF","Inclusion Criteria:\n\n* Diagnosed with idiopathic pulmonary fibrosis according to the 2018 guidelines of the American Thoracic Society\u002FEuropean Respiratory Society\u002FJapanese Respiratory Society\u002FLatin American Thoracic Association,\n* Diagnosed with IPF for at least 1 year,\n* Aged 18 years or older,\n* Able to express willingness and provide consent to participate in the study,\n* In possession of a tablet, smartphone, or computer and internet access via mobile or fixed network.\n\nExclusion Criteria:\n\n* Diagnosed with dementia,\n* Unable to speak, read, or write in Italian,\n* Legally blind or deaf,\n* In advanced stage of disease (receiving oxygen therapy at 10 to 15 liters per minute).",{"count":601,"type":23},124,[109],"A specific tool developed to measure self-care in patients with Idiopathic Pulmonary Fibrosis (IPF) is the SC-IPFI, which is an adaptation of an already validated instrument for COPD. It is important to assess how motivational interviewing can influence the self-care behaviors of these patients, better evaluate their level of disease management, prevent the risk of exacerbations, and guide educational interventions.\n\nThe primary objective of this study is to evaluate the effectiveness of a motivational interviewing program delivered remotely through video calls and digital platforms in improving the levels of self-care maintenance, self-care monitoring, and self-care management in patients with IPF. The study will also assess the effectiveness of the remotely delivered motivational interviewing program on self-efficacy, anxiety, disease-specific quality of life, therapy adherence, cough, dyspnea, exacerbations, and hospital admissions.",[30],"2025-09-16",{"date":607,"type":41},"2025-09-18",{"date":609,"type":23},"2025-10-01",{"date":611,"type":23},"2028-10-01",{"name":613,"class":143},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":615,"slug":616,"hasResults":12,"nctId":617,"briefTitle":618,"officialTitle":619,"acronym":4,"eligibilityCriteria":620,"healthyVolunteers":12,"sex":18,"minAge":83,"maxAge":4,"enrollmentInfo":621,"targetDuration":4,"studyType":188,"phases":4,"briefSummary":623,"conditions":624,"keywords":628,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":634,"lastUpdatePostDateStruct":635,"startDateStruct":637,"completionDateStruct":639,"leadSponsor":641,"locationsCount":531},"100606326","radiologic-features-of-rheumatoid-arthritis-interstitial-lung-disease-at-chest-high-resolution-computed-tomography-100606326","NCT07174102","Radiologic Features of Rheumatoid Arthritis Interstitial Lung Disease at Chest High Resolution Computed Tomography","Radiologic Features of Patients With Rheumatoid Arthritis Related Interstitial Lung Disease at Chest High Resolution Computed Tomography","Inclusion Criteria:\n\n* patients able to give their informed consent\n* at least aged 18 years\n* patients undergoing High-Resolution Computed Tomography (HRCT) for clinical needs at any point in their medical history\n* patients with a diagnosis of rheumatoid arthritis, idiopathic pulmonary fibrosis or connective tissue disease\n\nExclusion criteria:\n\nPatients younger than 18 and unable to give their informed consent.",{"count":622,"type":23},500,"Lung involvement is one of the most frequent extra articular involvements of rheumatoid arthritis (RA). RA related lung involvement can affect parenchyma, airway, vascular tree and serosa. Among all possible manifestations of lung disease, interstitial lung disease is the most severe being able to compromise quality of life and survival and involves about 20% of patients with rheumatoid arthritis (RA). However, chest high resolution computed tomography (HRCT) features of RA, with or without interstitial lung involvement, have not been clearly defined. Such features have been mostly investigated on small populations of RA patients, often including patients with connective tissue diseases (CTDs), namely systemic sclerosis, mixed connective tissue disease, idiopathic inflammatory myopathies, making difficult to discriminate possible specific features of RA interstitial lung disease (ILD).\n\nThe aims of this observational longitudinal study are to investigate: i) chest HRCT features of RA (frequency of radiologic HRCT patterns, fibrosis, nodules, bronchiectasis, etc.), associated or not to ILD; ii) possible associations between chest HRCT features and demographic, clinical and serologic characteristics of RA; iii) specific chest HRCT features of RA ILD, compared to idiopathic pulmonary fibrosis (IPF) and CTD ILD (i.e., primary Sjogren syndrome, idiopathic inflammatory myopathies, etc), according to the Centres availability.\n\nConsecutive, unselected, DICOM files of chest HRCT of adult RA patients (regardless a previous diagnosis of ILD) will be evaluated by an expert thoracic radiologist blinded to patients' clinical history.\n\nHRCT patterns, presence of fibrosis and other lung abnormalities (cysts, nodules, pleural effusion, etc) will be recorded. In patients with RA ILD possible associations with demographic and clinical disease features will be also analysed (such as sex, disease duration, disease duration at ILD diagnosis, presence of ACPA, rheumatoid factor, ANA), inclusion of previous therapies.\n\nAfter 2 years, new HRCT and lung function tests will be collected for each enrolled patients when available, to evaluate possible changes of lung involvement over time.",[625,626,30,627],"Reumatoid Arthritis","Interstitial Lung Disease Due to Systemic Disease (Disorder)","Connective Tissue Disease (CTD)",[629,630,631,632,633],"rheumatoid arthritis","Interstitial lung disease","connective tissue disease","idiopathic pulmonary fibrosis","high resolution computed tomography","2025-09-11",{"date":636,"type":41},"2025-09-15",{"date":638,"type":41},"2025-01-08",{"date":640,"type":23},"2035-01",{"name":642,"class":143},"Azienda Unita Sanitaria Locale di Piacenza"]