[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Mannkind Corporation\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":149},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,49,63,101,126],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"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":21,"type":22},210,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29],"Idiopathic Pulmonary Fibrosis","Idiopathic Pulmonary Fibrosis (IPF)",[31,32,33,34,35],"inhalable treatments","lung scarring","Pulmonary fibrosis","fibrosis","pulmonary","RECRUITING","2026-07-09",{"date":39,"type":40},"2026-07-13","ACTUAL",{"date":42,"type":22},"2026-06-30",{"date":44,"type":22},"2028-12",{"name":46,"class":47},"Mannkind Corporation","INDUSTRY",2,{"id":50,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":26,"conditions":53,"keywords":54,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":60,"leadSponsor":61,"locationsCount":62},"100645054",{"count":21,"type":22},[25],[28,29],[31,32,33,34,35],"NOT_YET_RECRUITING","2026-06-25",{"date":58,"type":40},"2026-07-01",{"date":42,"type":22},{"date":44,"type":22},{"name":46,"class":47},1,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":17,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":23,"phases":75,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},"100610187","phase-2-inhale-1st-afrezza-for-youth-with-newly-diagnosed-type-1-diabetes-100610187","NCT07224321","INHALE-1st: Afrezza® For Youth With Newly-Diagnosed Type 1 Diabetes","INHALE-1st: Technosphere Insulin (Afrezza®) In Combination With Basal Insulin For Youth With Newly-Diagnosed Type 1 Diabetes","INHALE-1st","Inclusion Criteria:\n\n* Age 10 to \\\u003C18 years of age\n* Clinical diagnosis of stage 3 T1D, per the investigator. Stage 3 is defined as hyperglycemia, meeting ADA glycemic and clinical diagnostic criteria\n* Able to start the Afrezza-BI regimen within 21 days following T1D diagnosis (day 1 is based on the first insulin dose)\n* Forced Expiratory Volume in One Second (FEV1) \\>80.0% of predicted Global Lung Function Initiative (GLI) value\n* Investigator believes that participant can be expected to follow the study protocol\n* No medical, psychiatric, psychosocial conditions, or medications being taken that in the investigator's judgment would be a safety concern for participation in the study\n\nExclusion Criteria:\n\n* Prior insulin treatment for stage 2 T1D\n* In the judgment of the investigator, history of chronic lung disease, such as asthma, or chronic obstructive pulmonary disease, lung cancer, or any other clinically important pulmonary disease (e.g., cystic fibrosis, bronchopulmonary dysplasia)\n* Allergy or known hypersensitivity to human regular insulin\n* Smoking (includes cigarettes, cigars, pipes, marijuana, and vaping devices) within 3 months prior to screening and\u002For positive cotinine test for smoking\n* Positive urine pregnancy test for female subjects of childbearing potential","10 Years","17 Years",{"count":74,"type":22},100,[25],"INHALE-1st is a Phase 2, single-arm, multi-center, clinical study evaluating the safety and efficacy of Afrezza in combination with subcutaneously-injected basal insulin (BI) for youth 10 to \\\u003C18 years old with newly diagnosed stage 3 type 1 diabetes (T1D). The study will also evaluate the effect of an Afrezza plus BI reigmen on participant and parent\u002Flegally authorized representative satisfaction. Participants will be followed for 13 weeks during the main phase followed by an optional Extension Phase for participants continuing to use Afrezza in combination with BI for up to 26 weeks.",[78],"Type 1 Diabetes Mellitus",[80,81,82,83,84,85,86,87,88,89,90,91],"Diabetes Mellitus","Insulin","Inhaled","Afrezza","Technosphere","Pediatric","Inhaled Insulin","Type 1 Diabetes","Newly diagnosed type 1 diabetes","Technosphere Insulin","rapid-acting inhaled insulin","Meal-time inhaled insulin","2026-06-15",{"date":94,"type":40},"2026-06-16",{"date":96,"type":40},"2026-02-04",{"date":98,"type":22},"2027-09",{"name":46,"class":47},10,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":23,"phases":111,"briefSummary":113,"conditions":114,"keywords":115,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":124,"locationsCount":125},"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":110,"type":22},24,[112],"PHASE1","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.",[29],[116,117],"Nintedanib","dry powder inhalation","2026-05-02",{"date":120,"type":40},"2026-05-05",{"date":122,"type":40},"2025-12-22",{"date":92,"type":22},{"name":46,"class":47},9,{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":133,"sex":17,"minAge":18,"maxAge":134,"enrollmentInfo":135,"targetDuration":4,"studyType":23,"phases":137,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":62},"100557040","phase-1-a-study-to-evaluate-safety-tolerability-and-pharmacokinetics-of-mknd-201-in-healthy-volunteers-100557040","NCT06532942","A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MKND-201 in Healthy Volunteers","A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Nintedanib Inhalation Powder (MNKD-201) in Healthy Volunteers","Key Inclusion Criteria:\n\n* Is ≥40 and ≤65 years of age at the time of signing the informed consent form.\n* Has a negative urine test for selected drugs of abuse and negative alcohol test at screening and upon admission to the CRU on Day -1. Note: Participants should not consume poppy seeds within 24 hours before urine drug screening because this can falsify the results of the opiate urine drug test.\n* Is willing to adhere to the restrictions and requirements specified in the protocol.\n* Has a negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test (i.e., the virus that causes COVID-19) on Day -1.\n* Is capable of performing spirometry, as required by the study procedures.\n\nKey Exclusion Criteria:\n\n* Has a history of significant lung disease (e.g., pulmonary fibrosis, cystic fibrosis, COPD, emphysema, chronic pulmonary infection, recent upper or lower respiratory tract infection in the prior 8 weeks, history of lung surgery or procedure, etc.)\n* Has endocrine, thyroid, or respiratory disease, diabetes mellitus, coronary heart disease, GI disease, or history of any psychotic mental illness.\n* Has a history of hepatic disease or has abnormal liver function tests (i.e., aspartate aminotransferase \\[AST\\] \\> 1.5 × upper limit of normal \\[ULN\\] or alanine aminotransferase \\[ALT\\] \\> 1.5 × ULN) at screening.\n* Has renal impairment (estimated glomerular filtration rate \\[eGFR\\] \\\u003C 60 mL\u002Fmin\u002F1.73 m2), as calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), at screening.\n* Has any history of pulmonary malignancy.\n* Has a history of substance abuse or dependency or history of recreational drug use over the last 2 years (by self-declaration).",true,"65 Years",{"count":136,"type":22},40,[112],"MKC-NI-001 is a Phase 1, first-in-human, randomized, double-blind, placebo-controlled study of nintedanib inhalation powder (MNKD-201) in healthy adult volunteers. The trial consists of a Single Ascending Dose (SAD), followed by a Multiple Ascending Dose (MAD) with a primary objective to evaluate the safety, tolerability, and pharmacokinetics (PK) of MNKD-201 compared to placebo in healthy adult participants.",[140],"Healthy Volunteers","2024-08-02",{"date":143,"type":40},"2024-08-06",{"date":145,"type":40},"2024-05-28",{"date":147,"type":22},"2024-10-31",{"name":46,"class":47},""]