[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-rhinosinusitis-with-nasal-polyps\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-rhinosinusitis-with-nasal-polyps":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,23,0,[8,43,66,100,126,155,176,198,222,244,265,287,310,331,356,383,405,425,444,465,487,508,530],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100632936","phase-3-a-study-to-investigate-nps-and-symptoms-in-chinese-adult-participants-with-crswnp-initiating-treatment-with-tezepelumab-100632936",false,"NCT07520162","A Study to Investigate NPS and Symptoms in Chinese Adult Participants With CRSwNP Initiating Treatment With Tezepelumab","BIFANG: A Multicentre, Single-Arm, Phase 3b Study to Assess Nasal Polyps Score and Symptoms in Chinese Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab","BIFANG","Inclusion Criteria:\n\n* Age\n\n  1\\. Participant must be 18 years of age or older, at the time of signing the informed consent.\n* Type of Participant and Disease Characteristics 2. Participants who are with physician-diagnosed CRSwNP for at least 12 months prior to Visit 1 who have all of the following:\n* Severity consistent with the need for surgery as defined by total NPS ≥ 4 (at least 2 for each nostril) at screening, as determined by the central reader\n* Mean NCS ≥ 2 in the 2 weeks prior to Visit 2\n* Ongoing documented NP symptoms for \\> 8 weeks prior to screening such as rhinorrhoea, reduction or loss of smell and\u002For poor quality\u002Floss of sleep\n* SNOT-22 total score ≥ 30 as assessed at screening. 3. Any standard of care for treatment of CRSwNP, which must include treatment with intranasal corticosteroids, provided the participant is stable on that treatment for at least 30 days prior to Visit 1. Investigators should also ensure that participants are compliant and on a stable dose of the background INCS during study period.\n\n  4\\. Either 1) documented treatment of NP exacerbation with SCS for at least 3 consecutive days or one IM depo-injectable dose (or contraindications\u002Fintolerance or intolerance to surgery) within the past 12 months prior to Visit 1 but not within the last 3 months prior to Visit 1 OR 2) any history of NP surgery (or contraindications\u002Fintolerance or intolerance to surgery).\n\n  5\\. Participants with JESREC score of ≥ 11.\n* Weight 6. Body weight of ≥ 40 kg at Visit 1.\n* Sex and Contraceptive\u002FBarrier Requirements 7. Male and\u002For female\n\nFemale participants:\n\n* Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Women of non-childbearing potential are defined as women who are either permanently sterilised (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal.\n* Women will be considered postmenopausal if they have been amenorrhoeic for 12 months prior to the planned start date of the first tezepelumab administration without an alternative medical cause.\n* The following age-specific requirements apply:\n\n  * Women \\\u003C 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatment and FSH levels within the postmenopausal range.\n  * Women \\> 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatment.\n* WOCBP must be willing to use one of the methods of contraception described hereafter, from the time of signing the ICF throughout the study and 16 weeks after last tezepelumab administration:\n\n  * Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal\n  * Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable\n  * Intrauterine device\n  * Intrauterine hormone-releasing system\n  * Bilateral tubal occlusion\n  * Vasectomised partner (vasectomised partner is a highly effective birth control method provided that the partner is the sole sexual partner of the WOCBP participant and that the vasectomised partner has received medical assessment of the surgical success)\n  * Sexual abstinence: it is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant.\n  * Cessation of contraception after this point should be discussed with a responsible physician.\n* Informed Consent 8. Provision of signed and dated written ICF prior to any mandatory study-specific procedures, sampling, and analyses.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n-Medical Conditions\n\n1. Participants with documented allergic fungal rhinosinusitis and\u002For central compartment atopic disease.\n2. Any clinically important pulmonary disease other than asthma (eg, active lung infection, bronchiectasis, pulmonary fibrosis, cystic fibrosis, primary ciliary dyskinesia, allergic bronchopulmonary mycosis, hypereosinophilic syndromes, etc) that could confound interpretation of clinical CRSwNP endpoints results.\n3. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and could:\n\n   * Affect the safety of the participant throughout the study\n   * Influence the findings of the study or the interpretation\n   * Impede the participant's ability to complete the entire duration of study\n4. Sinus surgery within 6 months of screening visit OR any sinus surgery in the past which changed the lateral wall of the nose making NPS evaluation impossible.\n5. Participants with conditions or concomitant disease that makes them non-evaluable for the primary CRSwNP endpoints such as:\n\n   * Antrochoanal polyps\n   * Nasal septal deviation that occludes at least one nostril\n   * Acute sinusitis, nasal infection, asthma exacerbation or upper respiratory infection at screening or in the two weeks before screening, or Churg-Strauss syndrome (also known as eosinophilic granulomatosis with polyangiitis), Young's syndrome or Kartagener's syndrome\n6. History of cancer:\n\n   * Participants who have had basal cell carcinoma, localised squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible to participate in the study provided that curative therapy was completed at least 12 months prior to Visit 1\n   * Participants who have had other malignancies are eligible provided that curative therapy was completed at least 5 years prior to Visit 1\n7. Uncontrolled epistaxis within 2 months of Visit 1.\n8. A helminth parasitic infection diagnosed within 6 months prior to Visit 1 that has not been treated with, or has failed to respond to, standard of care therapy.\n9. For participants with comorbid asthma: Current smokers or participants with a smoking history \\> 10 packs per year and participants using vaping products, including electronic cigarettes. Former smokers with a smoking history of \\\u003C 10 packs per year and users of vaping or e-cigarette products must have stopped for at least 6 months prior to Visit 1 to be eligible.\n10. History of chronic alcohol or drug abuse within 12 months prior to Visit 1.\n11. Tuberculosis requiring treatment within the 12 months prior to Visit 1. Particpiants who in the opinion of the investigator have evidence of active tuberculosis (TB), either treated or untreated, or latent TB without completion of an appropriate course of treatment or appropriate ongoing prophylactic treatment. Evaluation will be according to the local standard of care as determined by local guidelines and may consist of medical history and physical examinations, chest x-ray, sputum stain and\u002For culture, and\u002For TB test (eg, purified protein derivative or QuantiFeron test).\n12. Major surgery within 8 weeks prior to Visit 1 or planned NP surgery or planned surgical procedures requiring general anaesthesia or inpatient status for more than 1 day during the conduct of the study.\n13. History of known immunodeficiency disorder including a positive HIV test at Visit 1, or the participant taking antiretroviral medications as determined by medical history and\u002For participant's verbal report.\n14. Infection requiring systemic antibiotics within 14 days prior to Visit 1. Note: Participants with respiratory infections requiring antibiotics within 14 days prior to Visit 1 may extend their screening period to allow recovery and return no sooner than 14 days after completion of therapy.\n\n    -Prior\u002FConcomitant Therapy\n15. Receipt of any marketed or investigational biologic agent within 4 months or 5 half-lives (whichever is longer) prior to Visit 1 or receipt of any investigational non-biologic agent within 30 days or 5 half-lives (whichever is longer) prior to Visit 1.\n16. Treatment with systemic immunosuppressive\u002Fimmunomodulating drugs (eg, methotrexate, cyclosporine, etc.), except for SCS used in the treatment of asthma\u002Fasthma exacerbations, within the last 12 weeks or 5 half-lives (whichever is longer) prior to Visit 1.\n17. Receipt of immunoglobulin or blood products within 30 days prior to Visit 1.\n18. Receipt of live attenuated vaccines 30 days prior to the date of Visit 1 and during the study including the follow-up period.\n19. Known history of sensitivity to any component of the tezepelumab formulation or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation.\n20. History of anaphylaxis or documented immune complex disease (Type III hypersensitivity reactions) following any biologic therapy.\n21. Regular use of decongestants (topical or systemic) from Visit 1 onward is not allowed unless used for endoscopic procedure.\n22. Use of corticosteroid-eluting intranasal stents within 6 months prior to Visit 1 and during the study period.\n23. Recent aspirin desensitisation within 6 months of enrolment.\n\n    -Prior\u002FConcurrent Clinical Study Experience\n24. Concurrent enrolment in another clinical study involving a study intervention.\n\n    -Diagnostic Assessments\n25. Any clinically meaningful abnormal finding in physical examination, haematology, or clinical chemistry at Visit 1 which, in the opinion of the investigator, may put the participant at risk because of his\u002Fher participation in the study, or may influence the results of the study, or the participant's ability to complete the entire duration of the study.\n26. Evidence of active liver disease, including jaundice or AST, ALT, or ALP \\> 2 times ULN at Visit 1.\n27. Positive hepatitis B surface antigen, or hepatitis C antibody serology at screening, or a positive medical history for hepatitis B or C. Participants with a history of hepatitis B vaccination without a history of hepatitis B are allowed to participate.\n\n    -Other Exclusions\n28. Participants with JESREC score of \\\u003C11\n29. Involvement in the planning and\u002For conduct of the study (applies to both AstraZeneca staff and\u002For staff at the study site), or participants employed by or relatives of the relatives of the employees of the site or sponsor.\n30. Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.\n31. For women only: Pregnant, breastfeeding, or lactating women. A serum β-HCG pregnancy test must be drawn for WOCBP at the screening visit. If the results of the serum β-HCG cannot be obtained prior to dosing of the tezepelumab, a participant may be enrolled on the basis of a negative urine pregnancy test, though serum β-HCG must still be obtained. If either test is positive, the participant should be excluded. Since urine and serum tests may miss a pregnancy in the first days after conception, relevant menstrual history and sexual history, including methods of contraception, should be considered. Any participant whose menstrual and\u002For sexual history suggests the possibility of early pregnancy should be excluded.","ALL","18 Years",{"count":20,"type":21},230,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a multicentre, open-label, single-arm, Phase 3b study to assess nasal polyps score and symptoms in Chinese adult participants with chronic rhinosinusitis with nasal polyposis initiating treatment with tezepelumab.",[27],"Chronic Rhinosinusitis With Nasal Polyps",[29],"CRSwNP(Chronic Rhinosinusitis with Nasal Polyps)","RECRUITING","2026-06-23",{"date":33,"type":34},"2026-06-24","ACTUAL",{"date":36,"type":34},"2026-04-24",{"date":38,"type":21},"2028-03-07",{"name":40,"class":41},"AstraZeneca","INDUSTRY",21,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},"100627292","a-study-to-investigate-the-clinical-outcome-and-quality-of-life-in-chinese-post-operative-crswnp-patients-100627292","NCT07446738","A Study to Investigate the Clinical Outcome and Quality of Life in Chinese Post-operative CRSwNP Patients","PREDICT: A Prospective, Multicenter Real-World Study to Describe the Clinical Outcome and Quality of Life in Chinese CRSwNP Patients","PREDICT","Inclusion Criteria:\n\n1. Participant must be 16 years of age or older, at the time of signing the informed consent.\n2. Participants with a documented diagnosis of CRSwNP.\n3. Endoscopic nasal polypectomy is performed during the screening period.\n4. Voluntarily participate and sign the informed consent form as described in A 3.\n5. No history or current psychiatric disorders, with normal cognitive functions including understanding, expression, and orientation.\n\nExclusion Criteria:\n\n1. Any significant disease or disorder that the investigator believes may place the patient at risk or may affect the study results or the patient's ability to participate in the study.\n2. Currently participating in an interventional study.\n3. Patients who are unable to independently complete questionnaires due to language barriers or mental status.",{"count":52,"type":21},200,"OBSERVATIONAL","This is a prospective, multicenter real-world study to describe the postoperative outcomes and quality of life, disease control and characteristics of patients who underwent surgery, as well as economic burden and post-operative treatment patterns in Chinese patients with CRSwNP recurrence.",[27],[29],"2026-06-10",{"date":59,"type":34},"2026-06-11",{"date":61,"type":34},"2026-03-20",{"date":63,"type":21},"2027-10-21",{"name":40,"class":41},16,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":73,"enrollmentInfo":74,"targetDuration":4,"studyType":22,"phases":76,"briefSummary":78,"conditions":79,"keywords":80,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":4},"100643302","early-phase-1-thermosensitive-gel-nasal-spray-with-stem-cell-exosomes-mupirocin-and-dnase-i-for-chronic-sinusitis-100643302","NCT07635433","Thermosensitive Gel Nasal Spray With Stem Cell Exosomes, Mupirocin, and DNase I for Chronic Sinusitis","A Single-Centre, Randomised, Double-Blind, Placebo-Controlled Exploratory Clinical Study of a Thermosensitive Gel Nasal Spray Loaded With Umbilical Cord Mesenchymal Stem Cell Exosomes, Mupirocin and DNase I for the Treatment of Chronic Rhinosinusitis (Chronic Type Without Polyps)","Inclusion Criteria:\n\n* Age 18 to 65 years, both genders\n* Diagnosis of chronic rhinosinusitis without nasal polyps according to Chinese guidelines (2018), duration \\>12 weeks\n* Nasal endoscopy shows purulent secretions (Lund-Kennedy secretion score ≥1)\n* Nasal secretion culture positive for Staphylococcus aureus\n* Sino-Nasal Outcome Test-22 (SNOT-22) score ≥30\n* Voluntary signed informed consent\n\nExclusion Criteria:\n\n* Sinus surgery within past 6 months, or anatomical abnormalities requiring reoperation\n* Confirmed allergic fungal rhinosinusitis, odontogenic rhinosinusitis, or nasal polyps\n* Nasal discharge culture indicating Pseudomonas aeruginosa as primary pathogen\n* Primary ciliary dyskinesia, cystic fibrosis, or severe immunodeficiency\n* Use of systemic antibiotics or immunosuppressants within past 4 weeks\n* Use of intranasal corticosteroids within past 2 weeks\n* Hypersensitivity to mupirocin, DNase I, or any component of the formulation\n* Severe renal impairment (estimated Glomerular Filtration Rate, eGFR \\\u003C60 mL\u002Fmin\u002F1.73 m²)\n* Pregnant, breastfeeding, or planning to become pregnant during the study\n* Uncontrolled severe systemic diseases (diabetes, hypertension, autoimmune diseases)\n* Malignancy within past 5 years\n* Participation in other clinical trials","65 Years",{"count":75,"type":21},108,[77],"EARLY_PHASE1","This study tests a new nasal spray for adults (18-65 years) with chronic rhinosinusitis (CRS) without nasal polyps. The spray contains a temperature-sensitive gel (thermosensitive gel) that turns into a soft gel inside the nose to slowly release three active ingredients: human umbilical cord mesenchymal stem cell exosomes (hUC-MSC-Exo) to help heal the nasal lining, mupirocin (an antibiotic that kills Staphylococcus aureus bacteria), and DNase I (an enzyme that breaks down thick mucus). The study aims to check the safety of this triple combination and see if it can reduce infection, clear mucus, and improve symptoms. Participants will be randomly assigned to one of three groups: triple spray, a dual spray (without exosomes), or a placebo (gel only). The treatment is used twice daily for 4 weeks, with follow-up visits up to day 90. The study is single-centre, double-blind, and placebo-controlled. Outcome measures include safety (adverse events graded by Common Terminology Criteria for Adverse Events version 5.0, CTCAE v5.0), bacterial clearance rate, changes in nasal endoscopy score (Lund-Kennedy), quality of life (Sino-Nasal Outcome Test-22, SNOT-22), and nasal symptom visual analog scale (VAS).",[27],[81,82,83,84,85,86,87,88],"Chronic Rhinosinusitis","Thermosensitive Gel","Nasal Spray","Exosomes","Mupirocin","DNase I","Staphylococcus aureus","Double-Blind","NOT_YET_RECRUITING","2026-06-07",{"date":92,"type":34},"2026-06-09",{"date":94,"type":21},"2026-07-01",{"date":96,"type":21},"2027-06-30",{"name":98,"class":99},"The First Affiliated Hospital of Xinxiang Medical College","OTHER",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":107,"enrollmentInfo":108,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":125},"100525193","3d-printing-to-improve-nasal-irrigation-outcome-100525193","NCT06118554","3D Printing to Improve Nasal Irrigation Outcome","3D Printing for Topical Nasal Corticosteroid Irrigations: a Randomized Clinical Trial.","Inclusion Criteria:\n\n* Chronic rhinosinusitis without nasal polyps (CRSsNP) or Chronic rhinosinusitis with nasal polyps (CRSwNP).\n\nExclusion Criteria:\n\n* Patients with significant nasal polyps (as determined by a clinician) were excluded upfront due to the unlikeness of irrigation penetration regardless of the head position. Patients with significant atopy, cystic fibrosis, granulomatosis with polyangiitis or other connective tissue disorder, and current pregnancy were also excluded.","75 Years",{"count":52,"type":21},[110],"NA","Three-dimensional (3D) printing has been an emerging technology with uses in a wide array of fields. This research aims to use 3D printing as a tool to provide personalized education to maximize treatment efficacy based on the patient's individual anatomy. With increased irrigation to the sinuses, we hypothesize there will be improved patient satisfaction and higher quality of life. The outcomes of this research could lead to a new option for patients who live with chronic rhinosinusitis are not candidates for surgery or are interested in less invasive options. The 3D printed nasal replica is not something that would be implanted, rather it is a hand-held device used specifically for participants to better understand their nasal anatomy.",[27,113],"Chronic Rhinosinusitis Without Nasal Polyps",[115],"3D modeling","2026-05-21",{"date":118,"type":34},"2026-05-26",{"date":120,"type":34},"2021-11-01",{"date":122,"type":21},"2027-12-30",{"name":124,"class":99},"Ohio State University",1,{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":22,"phases":136,"briefSummary":137,"conditions":138,"keywords":140,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":125},"100341467","polysomnographic-findings-in-nasal-polyposis-100341467","NCT03725956","Polysomnographic Findings in Nasal Polyposis","Effects of Endoscopic Sinus Surgery on Sleep Disorder in Patients With Chronic Rhinosinusitis With Polyps","POLYSOMNO","Inclusion Criteria:\n\n* Patients who underwent endoscopic sinus surgery for recalcitrant nasal polyposis (failure of a 4-month corticosteroid medical treatment) Social insured patient\n* Patient willing to comply with all procedures of the study and its duration\n* Patient giving consent\n\nExclusion Criteria:\n\n* Patients with previous nasal surgery for nasal polyposis\n* Patients with previous continuous positive airway pressure therapy for obstructive sleep apnea\n* Non-coverage by the social security scheme\n* Patient unable to receive informed information\n* Refusal to sign the consent\n* Person deprived of the liberty\n* Person benefiting from a system of legal protection (guardianship…)",{"count":135,"type":21},30,[110],"Nasal polyposis (NP) is a chronic inflammatory disease of the nasal and sinus mucosa leading to protrusion of edematous polyps in the nasal cavity. Prevalence of NP among the chronic rhinosinusitis patients is 25-30 %. NP leads to significant limitations in physical, emotional and social aspects of life of the affected patients. Sleep disorder is frequently reported by those patients with impaired nasal breathing. Till now few studies have objectively assessed the impact of NP on sleep quality. the objectives are to figure out sleep disturbances in NP and to analyze the outcomes of sinus surgery on sleep recovering.",[27,139],"Obstructive Sleep Apnea",[141,142,143,144,145],"Nasal polyposis","sleep","sinus surgery","polysomnography","quality of life","2026-04-29",{"date":148,"type":34},"2026-05-06",{"date":150,"type":34},"2019-01-17",{"date":152,"type":21},"2026-12",{"name":154,"class":99},"University Hospital, Lille",{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":22,"phases":165,"briefSummary":166,"conditions":167,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":4},"100630173","phase-3-a-phase-3-study-to-assess-the-efficacy-safety-and-tolerability-of-itepekimab-anti-il-33-mab-in-adult-japanese-participants-with-inadequately-controlled-chronic-rhinosinusitis-with-nasal-polyps-100630173","NCT07484230","A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Adult Japanese Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps","A Randomized, Double-blind, Parallel-group, 52-week Trial to Investigate the Efficacy, Safety, and Tolerability of Itepekimab in Adult Japanese Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps","CEREN-4","Inclusion Criteria:\n\n* Participants must be 18 years of age or older.\n* Participants with a history of CRSwNP for at least 1 year.\n* Participants must have at least one of the following features:\n\n  * Prior sinonasal surgery for NP.\n  * Worsening symptoms of CRS requiring treatment with SCS within the prior 1 year.\n* An endoscopic bilateral NPS of at least 5 out of maximum score of 8 (with a minimum score of 2 in each nasal cavity).\n* Ongoing symptoms (for at least 12 weeks before Visit 1) of:\n\n  * Nasal congestion\u002Fblockade\u002Fobstruction with moderate or severe symptom (score of 2 or 3), AND\n  * At least one of the following two symptoms: loss of smell or rhinorrhea (anterior\u002Fposterior).\n* Not currently on and have not been receiving INCS for at least one month.\n* A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:\n\n  * Is not a women of childbearing potential (WOCBP), OR\n  * Is a WOCBP and agrees to use a contraceptive method that is highly effective, with a failure rate of \\\u003C1% during the study (at a minimum until 20 weeks after the last dose of study intervention).\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Participants with a history of clinically significant renal, hepatic, metabolic, neurologic, hematologic, ophthalmologic, respiratory (excluding those with asthma and AERD which may be included in the study), gastrointestinal, cardiovascular, cerebrovascular, or other significant medical illness or disorder, which, in the judgment of the Investigator, could interfere with the study or require treatment that might interfere with the study.\n* Participants who are currently smoking tobacco and\u002For vaping, or participants in whom smoking\u002Fvaping cessation has occurred \\\u003C6 months. Nicotine replacement therapy and\u002For noninhaled tobacco product use are not considered current smoking of tobacco.\n* Participants with a history of a severe systemic hypersensitivity reaction to a mAb.\n* Participants with conditions\u002Fconcomitant diseases making them non-evaluable or for the primary efficacy endpoint.\n* Participants with nasal cavity malignant tumor and benign tumors (eg, papilloma, blood boil, etc).\n* Participants with severe uncontrolled asthma with history of 2 and\u002For more exacerbations, requiring SCS or 1 hospitalization requiring SCS in the past year.\n* Participants treated with intranasal corticosteroid(s) (INCS), intranasal emitting devices\u002Fstents, nasal spray using exhalation delivery system such as XhanceTM one month prior during the screening period.\n* Participants who have undergone any sinus intranasal surgery (including polypectomy) within 6 months before Visit 1.\n* Participants who received SCS 1 month prior to Screening (Visit 1) or during the screening period (between Visit 1 and Visit 2).\n* Known allergy to itepekimab or its excipients, or any drug or other allergy that, in the opinion of the Investigator, contraindicates participation in this study.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"count":164,"type":21},20,[24],"This is a randomized, multicenter, double-blind, Phase 3 study with 2 parallel groups. The purpose of this study is to evaluate the efficacy, safety, and tolerability of 2 different dosing regimens of itepekimab monotherapy in Japanese participants aged 18 years or older with chronic rhinosinusitis with nasal polyp(s) (CRSwNP) who are not adequately controlled despite previous surgery and\u002For treatment with systemic corticosteroid(s) (SCS).\n\nThe total study duration par participant is approximately 76 week, including:\n\n* A screening period for up to 4 weeks.\n* A randomized study intervention period for up to 52 weeks\n* A post-intervention safety follow-up for up to 20 weeks\n* The number of visits will be 9 site visits and 20 phone\u002Fhome visits",[27],"2026-03-16",{"date":61,"type":34},{"date":171,"type":21},"2026-05-08",{"date":173,"type":21},"2028-10-10",{"name":175,"class":41},"Sanofi",{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":107,"enrollmentInfo":182,"targetDuration":4,"studyType":22,"phases":184,"briefSummary":185,"conditions":186,"keywords":187,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":4},"100625255","phase-3-a-randomized-double-blind-placebo-controlled-phase-iii-study-to-evaluate-the-efficacy-and-safety-of-cm326-in-participants-with-chronic-rhinosinusitis-with-nasal-polyposis-100625255","NCT07420257","A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of CM326 in Participants With Chronic Rhinosinusitis With Nasal Polyposis","Inclusion Criteria:\n\n1. Understand the study and voluntarily sign the informed consent form.\n2. Age between 18 and 75 years (inclusive) at the time of informed consent signing, regardless of gender.\n3. Diagnosis of bilateral chronic rhinosinusitis with nasal polyps (CRSwNP) meeting the diagnostic criteria of the \"Chinese Guidelines for the Diagnosis and Treatment of Chronic Rhinosinusitis (2024)\".\n4. Meet at least 1 of the following 4 items: a. Received SCS treatment for at least 3 consecutive days within 2 years prior to screening; b. Received at least one long-acting SCS (such as triamcinolone acetonide injection) within 2 years prior to screening; c. Had \\[c8.1\\]contraindications to SCS treatment or intolerance to SCS treatment; d. Received nasal polyp surgery more than 6 months prior to screening.\n5. Concurrent presence of the following symptoms for ≥\\[c9.1\\]8 weeks prior to the screening\u002Frun-in period: a. nasal congestion; b. Any\\[c10.1\\] other symptom such as hyposmia\u002Floss of smell or rhinorrhea\n6. Stable dose of intranasal corticosteroids (INCS) for \\>4 weeks prior to screening (participants using non-mometasone furoate nasal spray \\[MFNS\\] products must agree to switch to Mometasone Furoate Nasal Spray (MFNS) during the study). The evaluation during the lead-in period showed that the medication adherence to intranasal mometasone furoate nasal spray (MFNS) was greater than 70%.\n7. Bilateral Nasal Polyp Score (NPS) ≥5 (maximum score 8) with ≥2 points per nostril, as assessed by nasal endoscopy during screening and before randomization.\n8. Nasal Congestion Score (NCS) ≥2 at the screening visit and before randomization(weekly average score).\\[c11.1\\]\\[11.2\\]\n9. 22-item Sino-Nasal Outcome Test (SNOT-22) score ≥30 at screening and before randomization.\n10. Eligible participants of childbearing potential (males and females) must agree to use reliable contraceptive methods (hormonal contraceptives, barrier methods, or abstinence, etc.) with their partners during the trial and for 3 months after the last dose; Females of childbearing potential must be non-lactating, have a negative blood pregnancy test at screening, and have a negative blood or urine pregnancy test before randomization.\n\nExclusion Criteria:\n\n1. Presence of nasal conditions affecting NPS evaluation, including but not limited to: a. Antrochoanal polyps; b. Nasal septum perforation or severe nasal septum deviation occluding at least one nostril; c. Nasal surgery that alters the structure of the lateral nasal wall precluding completion of the NPS assessment.\n2. Clinically significant comorbidities other than asthma that may affect the efficacy assessment or interfere with the interpretation of the efficacy assessment results, including but not limited to: a. Allergic granulomatosis with polyangiitis (Churg-Strauss syndrome), granulomatosis with polyangiitis (Wegener's granulomatosis), allergic bronchopulmonary mycosis, and eosinophilic esophagitis; b. Bronchiectasis, pulmonary fibrosis, cystic fibrosis; c. Primary ciliary dyskinesia, Young's syndrome, Kartagner's syndrome, or other ciliary dyskinesia syndromes; d. Acute sinusitis, nasal infection, or upper respiratory tract infection at the time of the screening visit or within 2 weeks prior to the screening visit; e. Persistent rhinitis medicamentosa; f. Imaging suspected or confirmed fungal sinusitis; g. Malignant or benign tumors of the nasal cavity or paranasal sinuses.\n3. Uncontrolled epistaxis within 2 months prior to screening;\n4. Concomitant major chronic diseases that are uncontrolled and that, in the opinion of the investigator, may increase the safety risk of the participant's participation in this study;\n5. Participants with other concomitant active or clinically significant respiratory diseases that may significantly affect the study, as judged by the investigator;\n6. Participants with cardiovascular disease, and whose participation in this trial may affect the safety of the participants or the analysis of the study results at the discretion of the investigator.\n7. Active malignancy of any type or history of malignancy;\n8. Infection requiring systemic antibacterial, antiviral, antifungal, antiparasitic, or antiprotozoal treatment within 14 days prior to screening; Diagnosed with helminthic parasitic infection within 6 months prior to screening and untreated or refractory to standard therapy;\n9. History of active pulmonary tuberculosis within 12 months prior to screening, or old tuberculosis with high risk of recurrence as assessed by the investigator;\n10. Known or suspected history of immunosuppression, immune dysfunction or immune dysregulation, including but not limited to invasive opportunistic infections even if the infection has resolved, history of splenectomy, primary immunodeficiency, etc.; or unusually frequent, recurrent, or prolonged infections as judged by the investigator;\n11. Participants with comorbid asthma who have any of the following conditions: a. FEV1 ≤ 50% of the predicted normal value during the screening period and before baseline; b. Asthma exacerbation within 90 days prior to screening; c. Participants who are currently using inhaled corticosteroids at a daily dose higher than 1000 μg of fluticasone or equivalent, or who have started inhaled corticosteroids within 4 weeks prior to screening;\n12. Nasal surgery within 6 months prior to screening;\n13. Received medium- or short-acting SCS (including oral, intravenous, or intramuscular glucocorticoids) or traditional Chinese medicine (including systemic and topical traditional Chinese medicine preparations) for the treatment of chronic sinusitis within 4 weeks prior to screening, or received long-acting SCS (such as triamcinolone acetonide injection) within 6 weeks prior to screening, or plan to receive the above drugs during the study; Use of glucocorticoid-eluting intranasal stents within 6 months prior to screening;\n14. Patients who have received treatment with other biological agents other than anti-TSLP monoclonal antibodies, including but not limited to IL-4Rα monoclonal antibodies and anti-IgE monoclonal antibodies, within 8 weeks or 5 half-lives (whichever is longer) prior to screening;\n15. Previous treatment with anti-TSLP monoclonal antibody;\n16. Received systemic immunosuppressant therapy within 8 weeks or 5 half-lives (whichever is longer) prior to screening;\n17. Treatment with leukotriene receptor antagonists within 4 weeks before baseline;\n18. Regular use of decongestants (topical or systemic) within 4 weeks prior to screening, except for short-term use for endoscopy;\n19. Initiation of allergen-specific immunotherapy (desensitization therapy) within 3 months prior to baseline, or planned initiation of such therapy during the study period;\n20. Treatment with immunoglobulin or blood products within 30 days prior to screening;\n21. Any of the following infectious disease screening indicators meet the following criteria at screening: a. HBsAg positive or HBcAb positive and HBV-DNA positive; Patients who have received antiviral therapy in the past need to be excluded even if HBV-DNA is negative; b. HCV antibody positive and HCV-RNA positive. Patients who have received previous treatment for hepatitis C should still be excluded even if HCV-RNA is negative; c. Positive Treponema pallidum antibody test (if the Treponema pallidum particle agglutination test is positive, RPR or TRUST for syphilis is required. If the RPR or TRUST test is negative and the investigator judges that the participant has been infected with syphilis in the past but has been cured, he or she is eligible for inclusion); d. Human immunodeficiency virus antibody (Anti-HIV) positive.\n22. Clinically\\[c12.1\\] significant laboratory abnormalities that, in the opinion of the investigator, pose a risk to or affect the participant's participation in the study; Or meet any of the following criteria: a. Glutamate aminotransferase or aspartate aminotransferase \\>2.5×ULN; b. Total bilirubin and\u002For direct bilirubin \\>2×ULN; c. Absolute neutrophil count \\\u003C1.5×10\\^9\u002FL; d. Serum creatinine \\>1.5×ULN.\n23. Clinically significant abnormal findings found during the screening period, including physical examination, vital signs, 12-lead ECG, etc., which in the opinion of the investigator will pose a risk or affect the participant's participation in the study;\n24. Hypersensitivity to MFNS or CM326; History of severe systemic allergy to any biologic agent (except local injection site reaction);\n25. History of drug abuse, narcotics, and\u002For excessive alcohol consumption within 6 months prior to screening, as assessed by the investigator;\n26. Current smokers or participants with a smoking history of ≥10 pack-years;\n27. Vaccination with a live attenuated vaccine within 30 days prior to randomization or planned vaccination with a live attenuated vaccine during the study;\n28. Use of any other clinical study drug or medical device within 30 days or 5 half-lives (whichever is longer) prior to screening; Or still participating in or planning to participate in other clinical trials;\n29. As assessed by the investigator, the participant's poor compliance with this study (such as a clear history of mental disorder) makes it impossible to complete the study;\n30. Other medical or non-medical conditions that, in the opinion of the investigator, make the participant unsuitable for participation in this study.",{"count":183,"type":21},212,[24],"This is a multi-center, randomized, double blind, placebo-controlled Phase III study to evaluate the efficacy and safety of CM326, and to observe the Pharmacokinetics, Pharmacodynamics and I immumogenicity\\[c2.1\\] of CM326 in patients with chronic rhinosinusitis with nasal polyps (CRSwNP).The study consists of four periods, including an up to 4-week screening\u002Frun-in period, a 24-week double-blind randomized treatment period, a 28-week open-label treatment period, and an 8-week safety follow-up period.",[27],[188],"CM326，anti-TSLP biologics, Chronic rhinosinusitis with nasal polyps，allergy","2026-02-12",{"date":191,"type":34},"2026-02-19",{"date":193,"type":21},"2026-02-28",{"date":195,"type":21},"2028-10-30",{"name":197,"class":41},"CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.",{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":205,"enrollmentInfo":206,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":208,"conditions":209,"keywords":210,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":125},"100458180","dupilumab-treatment-effects-in-an-ethnically-diverse-population-with-chronic-rhinosinusitis-with-nasal-polyposis-100458180","NCT05246267","Dupilumab Treatment Effects in an Ethnically Diverse Population With Chronic Rhinosinusitis With Nasal Polyposis","Dupilumab Treatment Effects in an Ethnically Diverse Population With Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)","Inclusion Criteria:\n\n* Patients with physician-diagnosed CRSwNP, with or without comorbid asthma that meet indication criteria for FDA-approved use of Dupilumab.\n* Patients aged 18 years and older.\n* Patient willing to provide consent to be a participant in the study.\n* Patients with insurance that allows Dupilumab coverage or Dupilumab coverage obtained through \"Dupixent MyWay Program\"\n\nExclusion Criteria:\n\n* Age under 18\n* Suspected or diagnosed allergic fungal rhinosinusitis.\n* Suspected or diagnosed cystic fibrosis.\n* Dupilumab coverage denied through insurance or \"Dupixent MyWay Program\"\n* Patients who required a steroid taper in the preceding 30 days. However, patients on chronic steroids less or equal to 20 mg of prednisone daily, are eligible.\n* Patients who were on a different biologic medication in the preceding 3 months.\n* Patients with a diagnosis of EGPA\u002FChurg-Strauss Syndrome\n* Pregnant patients\n* Patients with inverted papilloma growth","99 Years",{"count":207,"type":21},60,"The central hypothesis of this study is that the addition of dupilumab treatment onto standard-of-care intranasal corticosteroids will improve patient-reported measures of disease activity and sense of smell in a cohort of mostly ethnical and racial minority patients with CRSwNP",[27],[211,212],"CRSwNP","dupilumab","2026-01-20",{"date":215,"type":34},"2026-01-22",{"date":217,"type":34},"2022-02-15",{"date":219,"type":21},"2026-06",{"name":221,"class":99},"Montefiore Medical Center",{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":228,"enrollmentInfo":229,"targetDuration":4,"studyType":22,"phases":231,"briefSummary":232,"conditions":233,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":241,"locationsCount":243},"100508094","early-phase-1-the-role-of-il5-in-epithelial-cell-integrity-100508094","NCT05895929","The Role of IL5 in Epithelial Cell Integrity","Inclusion Criteria:\n\n* (1) sinonasal inflammation for greater than 12 weeks which include at least 2 of the following symptoms: nasal obstruction\u002Fcongestion, nasal discharge (anterior or posterior), facial pressure\u002Fpain, reduction of sense of smell.\n* (2) confirmation of the clinical symptoms by: (2a) CT scan evidence of paranasal sinus mucosal inflammation, and\u002For (2b) endoscopic exam evidence of purulence from the sinuses or ostiomeatal complex; and\n* (3) presence of nasal polyps seen on endoscopic exam or sinus CT scan.\n\nExclusion Criteria:\n\n* 1\\. Children under the age of 18 will be excluded due to:\n\n  1. possible confounding diagnosis of cystic fibrosis and other non-Type 2 inflammatory etiologies that commonly presents with nasal polyps in the pediatric population.\n  2. lack of complete pneumatization of the majority of paranasal sinuses\n* 2\\. pregnant or lactating females,\n* 3\\. prisoners,\n* 4\\. mentally disabled\n* 5\\. persons unable to give informed consent will be contemplated for inclusion.\n* 6\\. disease secondary to a clearly defined anatomic process, such as facial trauma, and obstruction due to sinonasal neoplasm.\n* 7\\. exposure to oral or systemic IV glucocorticoids within 2 weeks of surgery\n* 8\\. exposure to immunomodulatory biologics will be excluded. These include, but are not limited to systemic treatment with biologics omalizumab, dupilumab, mepolizumab, benralizumab, reslizumab, or rituximab.","100 Years",{"count":230,"type":21},8,[77],"The goal of this laboratory study is the examine the effect of mepolizumab drug on the health and function of the cells lining the human nasal airways in vitro cell culture derived from patients with chronic rhinosinusitis with nasal polyposis. The main questions the study aims to study are:\n\n1. To see what mepolizumab does to suppress inflammation of the human cells.\n2. To see what mepolizumab does to maintain barrier integrity of epithelial cells",[27,234],"Chronic Rhinosinusitis (Diagnosis)","2026-01-09",{"date":237,"type":34},"2026-01-12",{"date":239,"type":34},"2023-09-05",{"date":219,"type":21},{"name":242,"class":99},"Johns Hopkins University",2,{"id":245,"slug":246,"hasResults":11,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":4,"eligibilityCriteria":250,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":107,"enrollmentInfo":251,"targetDuration":4,"studyType":22,"phases":253,"briefSummary":254,"conditions":255,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":125},"100603154","phase-3-efficacy-and-safety-of-shr-1905-injection-in-subjects-with-chronic-rhinosinusitis-with-nasal-polyps-100603154","NCT07132827","Efficacy and Safety of SHR-1905 Injection in Subjects With Chronic Rhinosinusitis With Nasal Polyps","A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Phase 3 Efficacy and Safety Study of SHR-1905 in Patiens With Chronic Rhinosinusitis With Nasal Polyps","Inclusion Criteria:\n\n1. Weight ≥40kg\n2. Diagnosed with chronic rhinosinusitis with nasal polyps (CRSwNP).\n3. Bilateral nasal polyps at screening and baseline, total NPS ≥5, ≥2 points for each nostril.\n4. NCS ≥2 at screening and baseline.\n5. SNOT-22≥30 at screening period and baseline.\n6. Recorded persistent NP symptoms for over 4 weeks prior to screening.\n7. Subjects received standard therapy with intranasal corticosteroids (INCS) prior to randomization.\n8. NP surgery in the past and\u002For SCS use within 1 years before screening(or with contraindications\u002F intolerances).\n\nExclusion Criteria:\n\n1. Any comorbidities that may affect the efficacy evaluation of nasal polyps.\n2. Any comorbidities except for asthma that may affect blood EOS levels.\n3. Concomitant with immunodeficiency.\n4. Concomitant with contraindications or not suitable for nasal endoscopy.\n5. Uncontrolled hypertension and\u002For uncontrolled diabetes.\n6. Concomitant with infection within 4 weeks prior to randomization.\n7. Uncontrolled epistaxis within 4 weeks prior to randomization.\n8. Major surgery performed within 3 months prior to randomization, or surgery planned during the study, or treatments that may affect evaluations according to investigators.\n9. Parasitic infection within 6 months before randomization.\n10. Sinus or intranasal surgery within 6 months prior to screening, or changes in the nasal walls caused by sinus or intranasal surgery that made NPS evaluation impossible.\n11. Malignancies diagnosed within 5 years before randomization (except those with a low risk of metastasis or death).\n12. Abnormalities of laboratory tests at screening or baseline.\n13. Concomitant with active hepatitis B, positive hepatitis C virus antibodies, positive human immunodeficiency virus antibodies, or positive treponema pallidum antibodies.\n14. Prolonged QTc interval or other clinically significant abnormal results of ECG at screening or baseline that may cause significant safety risks to subjects.\n15. FEV1 before the use of bronchodilator (pre-BD) was less than 50% at screening.\n16. Transfusion of blood products or immunoglobulin within 4 weeks prior to randomization.\n17. SCS or additional INCS use within 4 weeks before randomization, or planned use during treatment period.\n18. Regular use of decongestants (local or systemic) within 4 weeks before randomization, except for during the endoscopic procedure.\n19. Adnimistration of live vaccine or viral vector vaccine within 4 weeks before randomization.\n20. Allergen immunotherapy within 8 weeks before randomization.\n21. Smoking at screening, or smoking cessation less than 6 months at screening.\n22. Substance abuse, drug abuse, and\u002For excessive alcohol consumption within 1 year prior to randomization.\n\nPregnancy (including positive pregnancy test at screening or baseline), lactation, or pregnancy plan during study period.",{"count":252,"type":21},280,[24],"The study is being conducted to evaluate the efficacy, and safety of SHR-1905 injection in subjects with chronic rhinosinusitis with nasal polyps (CRSwNP)",[27],"2025-11-14",{"date":258,"type":34},"2025-11-17",{"date":260,"type":34},"2025-08-28",{"date":262,"type":21},"2028-04",{"name":264,"class":41},"Guangdong Hengrui Pharmaceutical Co., Ltd",{"id":266,"slug":267,"hasResults":11,"nctId":268,"briefTitle":269,"officialTitle":269,"acronym":4,"eligibilityCriteria":270,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":271,"targetDuration":4,"studyType":22,"phases":273,"briefSummary":275,"conditions":276,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":286},"100607363","phase-4-tapering-of-biologics-in-chronic-rhinosinusitis-with-nasal-polyps-100607363","NCT07187583","Tapering of Biologics in Chronic Rhinosinusitis With Nasal Polyps","Inclusion Criteria:\n\n* ≥18 years of age.\n* Currently receiving treatment with either dupilumab (300 mg) or mepolizumab (100 mg) every four weeks.\n* Having received the biologic at unchanged dosing interval for at least three months.\n* For at least one year during treatment with biologics, the patients' CRSwNP must be categorized as \"partly controlled\" as defined by presence of 1-2 of the following seven items (also available in EPOS 2020 table in protocol):\n\n  1. Nasal blockage: present on most days of the week\n  2. Rhinorrhoea\u002Fpostnasal drip: mucopurulent on most days of the week\n  3. Facial pain\u002Fpressure: present on most days of the week\n  4. Sense of smell: impaired\n  5. Sleep disturbance or fatigue: present\n  6. Nasal endoscopy: diseased mucosa\n  7. Rescue treatment (systemic corticosteroids, ESS, antibiotics): need of 1 course of rescue treatment\n\nof which 1-5 will be scored by the patient using VAS (0-10) and noted above 5.\n\nExclusion Criteria:\n\n* Patients with excellent response to biologics (0 of the above-mentioned 7 items for partly controlled disease)\n* Patients with no or limited response to biologics (\\>2 of the above-mentioned 7 items for partly controlled disease)\n* Patients with a cancer diagnosis deemed by the investigator to preclude participation in the trial\n* Patients who, because of language barriers, are not able to understand Danish written information and, thus, are not able to answer questionnaires\n* Patients who currently receive biologics for any other disease (asthma not included)\n* Patients who are not able to give informed consent (i.e., patients who are permanently incapable)\n* Patients who are not eligible because of the investigator's judgement\n* Patients who experience pregnancy during the study will be excluded after an unscheduled visit - active IVF treatment (please see below)\n* Unwillingness to follow the study procedure",{"count":272,"type":21},135,[274],"PHASE4","The purpose of this study is to investigate the feasibility of extending the dosing intervals of biological therapies while maintaining optimal treatment effects in chronic rhinosinusitis with nasal polyps (CRSwNP).",[27],"2025-09-18",{"date":279,"type":34},"2025-09-23",{"date":281,"type":34},"2025-06-05",{"date":283,"type":21},"2028-03-01",{"name":285,"class":99},"Rigshospitalet, Denmark",9,{"id":288,"slug":289,"hasResults":11,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":4,"eligibilityCriteria":293,"healthyVolunteers":294,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":295,"targetDuration":4,"studyType":22,"phases":297,"briefSummary":299,"conditions":300,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":125},"100607140","phase-2-sinonasal-microbiome-transplant-as-a-therapy-for-chronic-rhinosinusitis-crs-100607140","NCT07184684","Sinonasal Microbiome Transplant as a Therapy for Chronic Rhinosinusitis (CRS).","Sinonasal Microbiome Transplant as a Therapy for Chronic Rhinosinusitis (CRS): A Randomized , Placebo Controlled Cross Over Trial","Inclusion Criteria (CRS-Patients):\n\n* 2 nasal symptoms, 1 of which must be nasal obstruction or discolored discharge.\n* Sinusitis verified by endoscopy or CT scan\n* Duration \\> 12 weeks.\n* Signed informed consent to participate in the study.\n\nExclusion Criteria (CRS-Patients):\n\n* Antibiotic treatment in the last 3 months before study start.\n* Ongoing or recent participation in another clinical trial.\n* Any medication that might affect the results in an unpredictable manner.\n* Treatment with monoclonal antibodies (biologics).\n* Immunodeficiency other than low grade MBL deficiency.\n* Pregnancy or breastfeeding\n* Severe anatomical abnormalities.\n* SNOT 22 \\\u003C 20.\n\nInclusion Criteria (Donors):\n\n* No history of sinonasal or lower airway disease within the last two years other than the common cold.\n* Accepted as a donor by the patient.\n* Signed informed consent to participate in the study.\n\nExclusion Criteria (CRS-Patients):\n\n* Chronic rhinosinusitis.\n* Acute rhinosinusitis within the last two years.\n* Nasal polyposis\n* Antibiotic treatment within the last 3 months before the study start.\n* On going or recent participation in another clinical trial.\n* Findings in the pre study scan that makes the donor unsuitable.",true,{"count":296,"type":21},50,[298,24],"PHASE2","Chronic rhinosinusitis (CRS) is a disease associated with impaired quality of life and substantial societal costs. Much is still uncertain regarding the underlying etiology of the disease. Current treatment protocols are based on observed effects rather than a mechanistic understanding of the disease and thus patients often report unsatisfactory symptom reduction despite treatment with maximal medical therapy and even surgery.\n\nCRS is subgrouped phenotypically based on whether or not polyps are observed. Recently an endotypical differentiation reflecting the underlying inflammatory profile has been recommended as well, especially for research.\n\nIncreasing interest in the role of the commensal microbiome inflammatory diseases has followed a growing understanding of its profound impact on the human immune system. Current research indicates that instability and dysfunction of the microbiome is linked to inflammatory disease rather than compositional differences. Previous research has shown that microbiome transplants are effective in restoring the commensal microbiome and reducing inflammation in gastrointestinal disease and in a previous pilot study the investigators showed that sinonasal microbiome transplants are feasible and were associated with reduced symptoms in chronic rhinosinusitis without nasal polyps (CRSsNP).\n\nThis study will examine if the positive effect on patients symptoms observed in a previous pilot study are sustained in a placebo controlled, blinded study. In addition to this the study will also examine any differences in microbiome structure, stability, and function between patients with CRS and healthy donors as well as any correlation to disease phenotype or inflammatory endotype.",[113,27],"2025-09-14",{"date":303,"type":34},"2025-09-22",{"date":305,"type":34},"2024-10-14",{"date":307,"type":21},"2031-02",{"name":309,"class":99},"Region Skane",{"id":311,"slug":312,"hasResults":11,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":316,"eligibilityCriteria":317,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":205,"enrollmentInfo":318,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":320,"conditions":321,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":125},"100546740","effect-of-dupilumab-on-nasal-epithelial-barrier-function-in-patients-with-crswnp-100546740","NCT06398873","Effect of Dupilumab on Nasal Epithelial Barrier Function in Patients With CRSwNP","Effect of Dupilumab on Nasal Epithelial Barrier Function in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) - an Exploratory Pilot Study","EpiBar","Inclusion Criteria:\n\n* 18-99 years of age\n* Willingness to participate in the study\n* Suffer from chronic rhinosinusitis defined as in EPOS 2020 criteria, see main text\n* Group 1 (n=20, CRSsNP): Absence of nasal polyps\n* Group 2 (N=60, CRSwNP): Presence of nasal polyps as confirmed by endoscopy or CT and planned therapy with dupilumab\n* Presence or absence of non-steroidal anti-inflammatory drug (NSAID)-Exacerbated Respiratory Disease (N-ERD)\n* Patients with a history of treatment with monoclonal antibodies will only be included if at least a washout period of 6 months has passed\n\nExclusion Criteria:\n\n* Pregnancy (as determined by ß-HCG test) or breast feeding\n* Patients with severe anatomic variations or deviations that do not allow access to all areas in the nasal cavity\n* Patients with cystic fibrosis or primary ciliary dyskinesia\n* Patients with permanent immunosuppression\n* A mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study\n* Patients with clinically meaningful comorbidity as determined by the evaluating committee\n* Patients with a history of exacerbation of chronic rhinosinusitis 4 weeks prior to the screening visit\n* Intake of a burst of systemic corticosteroids for the treatment of CRS 4 weeks prior to the screening visit",{"count":319,"type":21},80,"The investigators aim to investigate two major so far unresolved topics in CRSwNP research: (1) Thorough functional and molecular characterisation of barrier function in patients suffering from CRSsNP and CRSwNP and (2) effect of dupilumab treatment on barrier function in polyp patients. This will be achieved in patient-derived samples by employing measurement of barrier function in primary cell cultures in combination with a mass cytometry based imaging approach, transcriptomic analysis as well as cytokine and microbiome data of individual patients.",[27,113],"2025-05-06",{"date":324,"type":34},"2025-05-07",{"date":326,"type":34},"2024-06-06",{"date":328,"type":21},"2027-09-01",{"name":330,"class":99},"Medical University of Vienna",{"id":332,"slug":333,"hasResults":11,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":337,"eligibilityCriteria":338,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":205,"enrollmentInfo":339,"targetDuration":4,"studyType":22,"phases":340,"briefSummary":341,"conditions":342,"keywords":345,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":351,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":355,"locationsCount":125},"100440012","moving-towards-precision-medicine-in-united-airways-disease-unraveling-inflammatory-patterns-in-asthmatic-patients-with-or-without-nasal-polyps-100440012","NCT05009758","Moving Towards Precision Medicine in United Airways Disease: Unraveling Inflammatory Patterns in Asthmatic Patients With or Without Nasal Polyps","Moving Towards PREcision Medicine In United Airways Disease: Unraveling inflaMmatory Patterns in Asthmatic Patients With or Without Nasal Polyps (PREMIUM) - a Descriptive Pilot Study","PREMIUM","Inclusion Criteria:\n\nAll patients who\n\n* 18-99 years of age\n* have a recorded clinical diagnosis of asthma (ICD-10 Code: J45)\n* undergo moderate-serve asthma treatment according to GINA\u002FDAL treatment step 4 or step 5 without oral corticosteroid or monoclonal antibody therapy\n* Asthma treatment for a minimum of 12 weeks prior to screening visit\n\n  * Group 1 and 2 - T2-high asthma with or without polyps:\n* FeNO \\> 25 ppB\n* had either two times \\>= 250 eosinophils \u002Fµl measured in the blood OR one measurement of blood eosinophils \\>= 250 cells\u002Fµl (one of the two measurements at the screening visit) and\u002For one measurement of sputum eosinophils \\> 2% within the last 12 months\n* Group with polyps: Presence of CRSwNP as confirmed by endoscopy or CT according to the European Position Paper on Rhinosinusitis and CRSwNP Guidelines)\n\n  * Group 3 - CRSwNP in absence of asthma:\n* Presence of CRSwNP as confirmed by endoscopy or CT according to the European Position Paper on Rhinosinusitis and Nasal Polyps Guidelines\n* Evidence of Type 2 inflammation: eosinophils \\>= 250 cells\u002Fµl measured in the blood OR total IgE \\>100 kU\u002FL at the screening visit\n* Absence of asthma and N-ERD\n* Patients with a history of treatment with monoclonal antibodies for asthma or polyps will only be included if at least a wash out period of 5 half-lives or at least 3 months have passed\n\nExclusion Criteria:\n\n* Pregnancy (as determined by ß-HCG test)\n* Patients with severe anatomic variations or deviations that do not allow access to all areas in the nasal cavity\n* Patients undergoing chronic oral corticosteroid therapy\n* Patients with any other confounding underlying lung disorder including but not limited to:\n\n  * Bronchiectasis, chronic obstructive pulmonary disorder (COPD), pulmonary fibrosis, emphysema, primary ciliary dyskinesia\n  * Cystic fibrosis, any known parasitic infections, and lung cancer\n* Patients with pulmonary conditions with symptoms of asthma and blood eosinophilia including but not limited to: Eosinophilic granulomatosis with polyangiitis (EGPA), allergic bronchopulmonary aspergillus, and hypereosinophilic syndrome\n* A mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study\n* Patients with clinically meaningful comorbidity as determined by the evaluating committee\n* Patients with a history of exacerbation of chronic rhinosinusitis or asthma 4 weeks prior to any visit\n* Intake of a burst of systemic corticosteroids 4 weeks prior to any visit.\n* Immunosuppressive treatment (e.g. cyclosporine)\n* Drug and alcohol abuses\n* Current smoker\n* Former smoker if stopped smoking \\\u003C6 months and\u002For has \\>10 pack-years",{"count":135,"type":21},[110],"Asthma and chronic rhinosinusitis (CRS) are inflammatory diseases of the respiratory tract, asthma from the lower part, and CRS, from the upper part. In theory, these parts are correlated as if they are one single organ, namely \"united airways\", which means that if one is affected by any condition, the other might be impacted as well. However, this relationship has not yet been described down to the cellular and molecular levels. By investigating patients that have (1) asthma and CRS with nasal polyp, (2) asthma and CRS without nasal polyp, and (3) just CRS with nasal polyp, we aim to determine the correlation of the upper and lower part of the respiratory tract. At first, the characterization of disease will be determined by established clinical criteria, such as lung function, blood analysis for the presence of eosinophils (a type of white cells), and nasal polyp score. To continue, in-depth analysis of nose, oropharynx, and lung samples will help gain information about the inflammatory profile and local microbiome of the three different groups of patients through molecular and cellular assays. The results of this study will help to describe the hypothesis of the united airways which will provide better guidance for medical treatment of asthma and CRS with or without polyp, thus improving the life quality of patients.",[343,27,234,344],"Asthma","Nasal Polyps",[343,346,347,348,349,350],"Chronic Rhinosinusitis (CRS)","CRS with Nasal Polyps","CRS without Nasal Polyps","Inflammatory profile","Type 2 inflammation",{"date":324,"type":34},{"date":353,"type":34},"2021-09-01",{"date":152,"type":21},{"name":330,"class":99},{"id":357,"slug":358,"hasResults":11,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":362,"eligibilityCriteria":363,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":364,"targetDuration":4,"studyType":22,"phases":366,"briefSummary":367,"conditions":368,"keywords":369,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":125},"100508584","phase-4-identifying-predictors-of-response-to-mepolizumab-in-crswnp-100508584","NCT05902325","Identifying Predictors Of Response To Mepolizumab In CRSwNP","Identifying Predictors Of Long-Lasting Response To Mepolizumab In CRSwNP: Is The Disease-Modifying Role Secondary To Restored Anti-Viral Activity Or Enhanced Epithelial Regeneration?","ISS-RESMEPO","Inclusion Criteria:\n\n* Bilateral NP, as diagnosed by endoscopy or historical CT scan\n* At least one NP surgery\\* within the last 10 years.\n* Severe NP symptoms consistent with a need for surgery (obstruction VAS symptom score\\>5, overall, VAS symptom score \\>7, endoscopic bilateral NP score ≥4 \\[with a score ≥2 in each nasal cavity\\]).\n* Ongoing treatment with INCS (via spray or intranasal liquid steroid wash\u002Fdouching) for ≥4 weeks prior to screening\n* ≥2 of the following CRS symptoms for at least 12 weeks:\n\n  * Nasal blockage\u002Fobstruction\u002Fcongestion\n  * Nasal discharge (anterior\u002Fposterior nasal drip)\n  * Facial pain\u002Fpressure\n  * Reduction or loss of sense of smell\n\nExclusion Criteria:\n\n* If as a result of a medical interview, physical examination, or screening investigation the physician responsible considers the participant unfit for the study.\n* Cystic fibrosis\n* Eosinophilic granulomatosis with polyangiitis (also known as Churg Strauss syndrome), Young's, Kartagener's or dyskinetic ciliary syndromes\n* Antrochoanal polyps\n* Nasal septal deviation occluding one nostril\n* Acute sinusitis or upper respiratory tract infection (URTI) at screening or 2 weeks prior to screening\n* Ongoing rhinitis medicamentosa (rebound or chemical-induced rhinitis)\n* Participants who have undergone any intranasal and\u002For sinus surgery (for example polypectomy, balloon dilatation or nasal stent insertion) within 6 months prior to V1\n* Participants where NP surgery is contraindicated in the opinion of the Investigator\n* Participants with a known medical history of HIV infection.\n* Participants with a known, pre-existing parasitic infestation within 6 months prior to Visit 1.\n* Participants who are currently receiving or have received within 3 months (or 5 half-lives - whatever is the longest) prior to the screening visit, radiotherapy, or investigational medications\u002Ftherapies.\n* Participants with a history of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation. Aspirin-sensitive participants are acceptable.\n* Participants with a history of allergic reaction to anti-IL-5 or other monoclonal antibody therapy.\n* Use of systemic corticosteroids (including oral corticosteroids) within 4 weeks prior to screening or planned use of such medications during the double-blind period\n* Treatments with biological or immunosuppressive treatment (other than Xolair) treatment within 5 terminal phase half-lives of Visit 1\n* Omalizumab (Xolair) treatment in the 130 days prior to Visit 1\n* Commencement or change of dose of allergen immunotherapy within the previous 3 months.\n* Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study. Contraceptive use will be required with a double barrier method or documented effective surgical sterilization.\n* Immunocompromised subjects from disease or medication, other than oral corticosteroids.\n* Women of childbearing potential (WOCBP) will be included with measures to prevent accidental exposure to IMP by using double barrier contraception and pregnancy test prior to injection.",{"count":365,"type":21},36,[274],"The investigators propose a real-world study to assess the mechanism of action of long-lasting response to mepolizumab in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP) and identify clinically useful predictors of response.\n\nMepolizumab is a monoclonal antibody targeting IL-5 and is approved for use in asthma and CRSwNP. In clinical studies, 12 months of treatment with mepolizumab improved signs and symptoms of CRSwNP and reduced the need for surgery. While several biologic medications targeting facets of the Type 2 mechanism are currently indicated for chronic rhinosinusitis with nasal polyps mepolizumab alone appears capable of modifying the disease's biological behaviour and producing long-standing improvements after the cessation of treatment. In the mepolizumab for CRSwNP regulatory trial (SYNAPSE), a subset of patients experienced dramatic and long-lasting, which is over 48 months after cessation of administration of the investigational medicinal product (IMP) in our experience. This has been partially captured in a follow-on study to the registration trail, which showed that a subset of patients followed for 24 weeks after cessation of biologic therapy (with continued use of mometasone furoate) demonstrated persistent improvements over baseline.\n\nHowever, the mechanism of the long-lasting effect in a subset of patients is not well understood, and it is impossible currently to identify patients who will derive this maximal benefit. The mechanism for the prolonged improvements in CRSwNP seen in certain patients with mepolizumab remains to be established but suggests that effects beyond eosinophil trafficking are implicated.\n\nThe investigators believe that mepolizumab has IL-5-mediated pleiotropic effects which contribute to disease modification with effects extending beyond eosinophil activation and trafficking. This may include the following primary or secondary effects:\n\ni) Improving epithelial barrier function ii) Altering mast cell dynamics iii) Reversing epigenetic modifications iv) Altering the immune response to better clear pathogenic bacteria or viruses.",[27],[211,370,371,372,373],"Epigenetic","Virus","Multiomics","Mepolizumab","2025-02-12",{"date":376,"type":34},"2025-02-14",{"date":378,"type":34},"2023-10-03",{"date":380,"type":21},"2026-12-31",{"name":382,"class":99},"Centre hospitalier de l'Université de Montréal (CHUM)",{"id":384,"slug":385,"hasResults":11,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":4,"eligibilityCriteria":389,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":390,"targetDuration":4,"studyType":22,"phases":392,"briefSummary":393,"conditions":394,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":125},"100429235","phase-4-olfactory-outcomes-of-dupilumab-treatment-for-nasal-polyposis-100429235","NCT04869436","Olfactory Outcomes of Dupilumab Treatment for Nasal Polyposis","The 'Real World' Olfactory Outcomes Treating Nasal Polyposis With Dupilumab","Inclusion Criteria:\n\n* Patients older than 18 years old\n* Chronic rhinosinusitis with Nasal Polyps\n* Olfactory loss\n* Clinical indication for treatment with Dupilumab\n\nExclusion Criteria:\n\nPatients with olfactory loss from other causes such as:\n\n* Sinonasal malignancies\n* Trauma\n* Idiopathic olfactory loss\n* Use of cocaine\n* COVID-19 related olfactory loss\n* Pregnancy",{"count":391,"type":21},27,[274],"The study aims to investigate the olfactory TDI score (Threshold, Discrimination, Identification) using the Sniffin' sticks test for patients with chronic rhinosinusitis with nasal polyps (CRSwNP) on dupilumab. Twenty-seven adult patients will be followed up during the treatment with dupilumab on three visits to the Otolaryngology Clinic (Baseline, 3 months and 6 months).\n\nThe primary endpoint will be the TDI score. Nasal polyp score, Quality of Olfactory Disorders - negative symptoms (QOD-NS symptom scores), SNOT-22 will be secondary endpoints.",[27,395],"Olfactory Disorder","2024-12-18",{"date":398,"type":34},"2024-12-20",{"date":400,"type":34},"2021-07-19",{"date":402,"type":21},"2025-12-01",{"name":404,"class":99},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's",{"id":406,"slug":407,"hasResults":11,"nctId":408,"briefTitle":409,"officialTitle":409,"acronym":4,"eligibilityCriteria":410,"healthyVolunteers":11,"sex":17,"minAge":411,"maxAge":4,"enrollmentInfo":412,"targetDuration":4,"studyType":22,"phases":414,"briefSummary":415,"conditions":416,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":423,"locationsCount":4},"100572959","phase-3-opening-the-black-box-on-tezepelumabs-effect-on-chronic-rhinosinusitis-with-severe-asthma-100572959","NCT06740045","Opening the \"Black Box\" on Tezepelumab's Effect on Chronic Rhinosinusitis With Severe Asthma","Inclusion Criteria:\n\n* Must be ≥19 of age at the time of signing the informed consent form\n* Capable of giving signed informed consent.\n* Having CRSwNP based on clinical symptoms and\u002For radiographic or endoscopic evidence of inflammation in their upper airways (Diagnosis consistent with EPOS 2020)(2)and severe asthma:\n\n  * SA based on GINA criteria (37) and confirmed with spirometry and assessmenton the previous history of asthma (a pre-post bronchodilator spirometry ormethacholine challenge to document the positive or negative history of asthmawill be performed if there is no clinical record).\n  * Nasal polyp score (NPS) of at least 2 on each side\n* Females of childbearing potential must commit using an acceptable method of birthcontrol for the duration of the study and they must have a negative urine pregnancy test ateach study visit\n* Not expecting to have surgery within the next 7 months\n\nExclusion Criteria:\n\n* Have previously undergone sinus surgery or nasal polypectomy\n* A history of organ transplantation such as lung transplantation\n* Previously or currently using immunomodulator medications or antihistamines\n* A history of auto-immune diseases\n* Current or past sinonasal or bronchial tumors\n* Currently using systemic or oral corticosteroids\n* Women who are pregnant, plan to become pregnant, or breastfeed during the trial\n* Current participation in any other interventional treatment trials\n* Compliance: is unlikely to comply with study visits based on investigator judgment:\n* Diagnosed or suspected malignant or premalignant nasal disease (e.g. SchniderianPapilloma, unilateral nasal polyposis)\n* Fungal rhinosinusitis (CT\u002FHistology), positive Aspergillus skin prick testing and\u002Forpositive Aspergillus IgE RAST (Radioallergosorbent) testing\n* Malignant neoplasm within 5 years (from screening) excluding basal cell or squamouscell carcinoma of the skin treated with local resection only or carcinoma in situ of the uterinecervix treated locally and without metastatic disease for 3 years.\n* Active bleeding disorders, and\u002For inability to support interruption to anticoagulant or anti-platelet therapies for nasal biopsy.\n* Severe nasal deformity precluding endoscopic assessment\u002Fbiopsy of postnasal space\n* Have an acute or chronic infection (excluding that related to CRS) requiring managementas follows:\n\n  * Currently on any treatment for a chronic infection such as pneumocystis,cytomegalovirus, herpes simplex virus, herpes zoster, or atypical mycobacteria\n  * Hospitalisation solely for the treatment of proven infection requiring parenteral (IV orIM) antibiotics (antibacterial, antiviral, antifungal, or anti-parasitic agents) within 60days of Day 1\n  * Proven severe infection requiring outpatient treatment with parenteral (IV or IM)antibiotics (antibacterial, antiviral, antifungal, or anti-parasitic agents) within 60 daysof Day 1. Prophylactic anti-infective treatment is allowed.\n* Known positive human immunodeficiency virus (HIV) status\n* Known positive Hepatitis B (HB) or Hepatitis C status\n* Have clinical evidence of significant unstable or uncontrolled acute or chronic diseaseswhich, in the opinion of the principal investigator, could confound the results of the study orput the participant at undue risk\n* Have a planned surgical procedure, laboratory abnormality, or condition that, in theopinion of the principal investigator, makes the participant unsuitable for the study.\n* Have received any investigational agent (that is not approved for sale in Canada) within60 days of Day 1\n* Smoking history; current or former smokers with a smoke history of packs year \\>15\n* Subjects with parasitic (helminthic) infection\n* Subjects with hypersensitivity; with allergy\u002Fintolerance to a monoclonal antibody or biologics\n* Subjects allergic to Aspirin (ASA) and non-steroidal anti-inflammatory drugs (NSAIDs)","19 Years",{"count":413,"type":21},10,[24],"The study explores how chronic rhinosinusitis (CRS) and asthma share a common inflammatory process, particularly affecting patients with both conditions. Interaction between immune cells (Interleukins) and Th2 cytokines, such as TSLP, exacerbates asthma control in CRS patients, especially those with nasal polyps (CRSwNP). TSLP plays a pivotal role in initiating and maintaining airway inflammation in both diseases. Tezepelumab, a biologic therapy targeting TSLP, shows promise in reducing inflammation markers in severe asthma but its impact on CRSwNP and quality of life remains unclear. The study proposes investigating Tezepelumab's efficacy in treating CRSwNP and severe asthma to inform future biologic therapies.",[343,27],"2024-12-13",{"date":396,"type":34},{"date":420,"type":21},"2025-01",{"date":422,"type":21},"2025-06",{"name":424,"class":99},"Dr. Andrew Thamboo, MD",{"id":426,"slug":427,"hasResults":11,"nctId":428,"briefTitle":429,"officialTitle":430,"acronym":4,"eligibilityCriteria":431,"healthyVolunteers":11,"sex":17,"minAge":411,"maxAge":4,"enrollmentInfo":432,"targetDuration":4,"studyType":22,"phases":433,"briefSummary":434,"conditions":435,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":437,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":443,"locationsCount":4},"100558833","phase-4-immunologic-impact-of-dupilumab-in-patients-suffering-from-asthma-and-chronic-rhinosinusitis-with-polyps-100558833","NCT06556264","Immunologic Impact of Dupilumab in Patients Suffering From Asthma and Chronic Rhinosinusitis With Polyps","Determining the Immunologic Impact of Dupilumab on the Unified Airway System in Patients Suffering From Asthma and Chronic Rhinosinusitis With Polyps","Inclusion Criteria:\n\n* Patients over the age of 19.\n* Patients undergoing Endoscopic Sinus Surgery (ESS)\n* Patients with CRSwNP with moderate-severe asthma according to 2020 EPOS criteria:\n\n  1. Asthma confirmed with spirometry and assessment on the previous history of asthma (a methacholine challenge test and atopy testing to document the positive or negative history of asthma will be performed if there is no clinical record). Asthma severity based on GINA guidelines.\n  2. Presence of nasal polyps. This can be based on the formal exam at Baseline Visit or historical assessment.\n\nExclusion Criteria:\n\n* Patients with current or past sinonasal or bronchial tumours\n* Subjects who have been treated with oral antibiotics in the past month prior to surgery\n* Subjects with known immunodeficiency\n* Subjects with known autoimmune disease\n* Subjects with other sinonasal diseases other than CRSwNP (e.g., cystic fibrosis, eosinophilic granulomatosis with polyangiitis, allergic fungal rhinosinusitis, invasive fungal sinusitis, fungal ball, dyskinetic cilia syndrome)\n* Prior lung transplants\n* Subjects with hypersensitivity; with allergy\u002Fintolerance to a monoclonal antibody or biologic\n* Prior use of dupilumab or other biologic medications (omalizumab. mepolizumab, reslizumab,etc) 6 months before enrollment.\n* Any condition that, in the opinion of the investigator, may interfere with the patient's ability to participate in the study per protocol.\n* Participation in an ongoing interventional or observational study using a biologic treatment.\n* Female participants who are pregnant or breastfeeding",{"count":207,"type":21},[274],"The investigators are studying adults who have chronic rhinosinusitis with nasal polyps (CRSwNP) and moderate to severe asthma, and who are undergoing Endoscopic Sinus Surgery (ESS). Investigators want to understand how adding a medication called dupilumab to their usual treatment affects inflammation in their upper and lower airways over 24 weeks.\n\nDupilumab works by blocking certain signals in the immune system that contribute to inflammation in both the sinuses and the lungs. By studying how this medication changes the immune profiles of both airway systems, investigators hope to learn more about the underlying causes of airway inflammation in these conditions.\n\nThis research is important because it may help understand if treating inflammation in one part of the airway (like the lungs) has a similar effect on inflammation in another part (like the sinuses). This could lead to better treatments for people with CRSwNP and asthma, targeting the root causes of their symptoms more effectively.",[27,343],"2024-08-13",{"date":438,"type":34},"2024-08-16",{"date":440,"type":21},"2024-08",{"date":442,"type":21},"2025-12",{"name":424,"class":99},{"id":445,"slug":446,"hasResults":11,"nctId":447,"briefTitle":448,"officialTitle":449,"acronym":4,"eligibilityCriteria":450,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":107,"enrollmentInfo":451,"targetDuration":4,"studyType":22,"phases":453,"briefSummary":454,"conditions":455,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":456,"lastUpdatePostDateStruct":457,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":125},"100544729","phase-2-study-of-cm326-in-participants-with-chronic-rhinosinusitis-with-nasal-polyposis-100544729","NCT06372678","Study of CM326 in Participants With Chronic Rhinosinusitis With Nasal Polyposis","A Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of CM326 in Participants With Chronic Rhinosinusitis With Nasal Polyposis","Inclusion Criteria:\n\n* Male or female subjects, aged between 18 and 75 years old (inclusive).\n* Subjects who are capable of understanding the nature of the study and voluntarily signing the Informed consent form (ICF).\n* Prior treatment with systemic corticosteroids (SCS) within two years before screening, and\u002For contraindicate to or intolerance to systemic corticosteroids, and\u002For with prior surgery to nasal polyps 6 months before the screening.\n\nExclusion Criteria:\n\n* Allergic or intolerant to mometasone furoate spray or CM326.\n* Have received allergen-specific immunotherapy that initiated within 3 months prior to randomization or planned to be initiated during the study period.\n* Participated study of CM326.\n* Systemic immunosuppressive therapy for inflammatory or autoimmune diseases within 8 weeks or 5 half-lives prior to baseline (whichever is longer).\n* Starting leukotriene receptor antagonist therapy within 4 weeks prior to baseline.\n* With antrochoanal polyps.\n* With severe deviation of the nasal septum occludes at least one nostril.\n* With persistent rhinitis medicamentosas.\n* With acute sinusitis, nasal infection, or upper respiratory tract infection at screening.\n* Have symptoms or whose CT scan suggests allergic fungal sinusitis.\n* With malignant or benign neoplasm of nasal cavities.\n* With other uncontrolled serious diseases or recurrent chronic diseases.\n* Have severe hepatic and renal impairment.",{"count":452,"type":21},90,[298],"This is a multi-center, randomized, double blind, placebo-controlled Phase II study to evaluate the efficacy and safety of CM326, and to observe the Pharmacokinetics, Pharmacodynamics and immumogenicity of CM326 in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP).",[27],"2024-04-15",{"date":458,"type":34},"2024-04-18",{"date":460,"type":21},"2024-06-30",{"date":462,"type":21},"2026-06-30",{"name":464,"class":41},"Keymed Biosciences Co.Ltd",{"id":466,"slug":467,"hasResults":11,"nctId":468,"briefTitle":469,"officialTitle":470,"acronym":471,"eligibilityCriteria":472,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":473,"enrollmentInfo":474,"targetDuration":476,"studyType":53,"phases":4,"briefSummary":477,"conditions":478,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":480,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":485,"locationsCount":125},"100511402","real-life-study-of-biologicals-in-patients-with-severe-crswnp-100511402","NCT05938972","Real Life Study of Biologicals in Patients With Severe CRSwNP","Real Life Study Assessing Long Term Outcomes and Predictive Factors of Response to Biologicals in Patients With Severe CRSwNP and\u002For Severe Allergic and\u002For Eosinophilic Asthma","NASUMAB","Inclusion Criteria:\n\nPatients must meet the following criteria to be eligible for the enrolment in the study:\n\n* Signed informed consent form (ICF),\n* Age between 18 and 80 years at time of signing ICF,\n* Able to comply with the study protocol, in the investigator's judgment,\n* In group one: patients with severe allergic and\u002For eosinophilic asthma, defined by being currently treated with a biological (SoC) OR starting treatment with a biological (SoC).\n* In group two: patients with CRSwNP with or without asthma, defined by starting treatment with a biological (SoC) and fulfill the criteria for reimbursement of a biological therapy\n\nExclusion Criteria:\n\nPatients who do not meet the reimbursement criteria of a biological therapy cannot participate in the study.","80 Years",{"count":475,"type":21},180,"24 Months","This study is a pragmatic, real-life, observational study recruiting adult patients with chronic rhinosinusitis with nasal polyposis who are eligible to start biologicals as standard treatment. The aim of this study is to observe the long-term outcomes of biologicals in CRSwNP patients with or without comorbid asthma in 'real life'. Moreover, the investigators will gain insight into the mechanisms of biologicals in the local and systemic immunity of these patients and investigate novel local and systemic biomarkers and predictors of response.",[27],"2024-04-11",{"date":456,"type":34},{"date":482,"type":34},"2022-03-01",{"date":484,"type":21},"2030-12-31",{"name":486,"class":99},"University Hospital, Ghent",{"id":488,"slug":489,"hasResults":11,"nctId":490,"briefTitle":491,"officialTitle":491,"acronym":4,"eligibilityCriteria":492,"healthyVolunteers":294,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":493,"targetDuration":495,"studyType":53,"phases":4,"briefSummary":496,"conditions":497,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":500,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":506,"locationsCount":125},"100526039","basal-instincts-towards-better-understanding-of-basal-cell-function-in-chronic-rhinosinusitis-with-nasal-polyps-100526039","NCT06129552","Basal Instincts: Towards Better Understanding of Basal Cell Function in Chronic Rhinosinusitis With Nasal Polyps","Inclusion Criteria:\n\n* Patients over the age of 18\n* Males and females\n\nExclusion Criteria:\n\n* CRSwNP\n* AR\n* Smoker, or \\\u003C 1-year ex-smoker\n* Underlying systematic pathology (Morbus Wegener or Churg Strauss Syndrome for example)",{"count":494,"type":21},300,"1 Day","During this project, the investigators want to explore in vitro changes in basal cells and the crosstalk with residing immune cells as potential pathogenic mechanisms in CRSwNP vs healthy controls by using surgically resected patient samples.",[27,498],"Allergic Rhinitis","2024-03-21",{"date":501,"type":34},"2024-03-22",{"date":503,"type":34},"2023-12-19",{"date":505,"type":21},"2027-12",{"name":507,"class":99},"Universitaire Ziekenhuizen KU Leuven",{"id":509,"slug":510,"hasResults":11,"nctId":511,"briefTitle":512,"officialTitle":513,"acronym":514,"eligibilityCriteria":515,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":516,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":518,"conditions":519,"keywords":520,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":522,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":528,"locationsCount":243},"100493680","biomarkers-of-response-to-mepolizumab-treatment-in-patients-with-nasal-polyps-with-or-without-bronchial-asthma-100493680","NCT05708300","Biomarkers of Response to Mepolizumab Treatment in Patients With Nasal Polyps With or Without Bronchial Asthma","Novel Insight in pathologiCal and clinicAl Attributes in Response to mepoLizumab Treatment in Patients With Chronic rhInosinusitis With Nasal pOlyPs With or Without bronchIal Asthma on a Long-term Basis (CALIOPI STUDY)","CALIOPI","Inclusion Criteria:\n\n* Adult patients \\> 18 years with bilateral Nasal Polyps\n* Symptoms VAS scores (for nasal obstruction, hyposmia, post-nasal drip, sneezing, rhinorrhea; 0-10 for each symptom) \\> 24 in spite of treatment with standard of care treatment.\n* Patients with bilateral sinonasal polyps with a need for surgery as described by: Lund-Mackay score \\> 4, Lund Kennedy score \\> 6, a minimum total Nasal polyp score of 5 out of a maximum score of 8 at screening, ongoing symptoms for at least 12 weeks prior to screening,\n* Concerning patients with asthmatics with nasal polyps: subjects must have a medical history of asthma as confirmed by asthma related symptoms and by bronchodilator response (BDR) (GINA 2022) or positive methacholine challenge according to ERS guidelines.\n\nExclusion Criteria:\n\n* Pregnant or nursing women, or women of child-bearing potential.\n* Biologic therapy (eg: Omalizumab, Mepolizumab, Reslizumab, Dupilumab) or previous treatment with Mepolizumab\n* Allergen immunotherapy in the past 6 months\n* Systemic corticosteroid treatment for other chronic conditions (i.e.: autoimmune disorders, tumors, etc)\n* Prior\u002Fconcomitant therapy: use of immunosuppressive medication (including but not limited to: methotrexate, troleandomycin, cyclosporine, azathioprine, or any experimental anti-inflammatory therapy) within 3 months prior to Visit 1 and during the study period.\n* Evidence of active systemic immunodepression (i.e..: primary or secondary immunodeficiency)\n* History of malignancy of any organ system or any other serious co-morbidities defined by the treating physician.\n* Primary diagnosis of lung disease other than asthma (chronic obstructive lung disease (COPD), asthma-COPD overlap (ACO), interstitial lung disease, sarcoidosis, bronchiectasis, cystic fibrosis, primary ciliary dyskinesia, active tuberculosis, allergic bronchopulmonary aspergillosis (ABPA), current lung cancer or other blood, lymphatic or solid organ malignancy, autoimmune diseases of the skin, muscle-skeletal or gastrointestinal system needing systemic corticosteroids, immunosuppressants or biologic treatment as well as individuals with granulomatosis with polyangiitis (Wegener's granulomatosis) and eosinophilic granulomatosis polyangiitis (Churg-Strauss syndrome).\n* Nasal polyps' or Asthma exacerbation, within 12 weeks prior to screening that required oral corticosteroids over 3 days or hospitalization or emergency room visit.",{"count":517,"type":21},57,"Mepolizumab is a biologic agent already approved for severe asthma. Recently, there is increasing evidence concerning the benefit of anti-IL5 treatments upon patients with nasal polyposis with or without severe asthma.\n\nThe novelty of this project is that no biologic agent has yet been fully investigated to identify any biomarkers of response for patients with nasal polyps with or without asthma including sinonasal tissue remodeling a key element in the resultant histopathological changes of the inflammation. The investigation of airway remodeling of various locations (nose and bronchus) under mepolizumab treatment will be our primary objective on the long-term basis of 156 weeks of treatment.\n\nEndobronchial and nasal biopsies will be performed as routine care for tissue evauation and disease investigation for every patient.\n\nBesides, the united airways will provide better guidance for medical treatment of chronic rhinosinusitis (CRS) patients with nasal polyps (CRSwNP) and asthma.\n\nThe initial idea is based on investigating the characteristics that could predict the effectiveness of mepolizumab on patients with nasal polyposis with or without asthma. Patients will receive 39 doses of mepolizumab for 156 weeks. An additional aim of this study is to identify characteristics of non-responders and responders to mepolizumab. Responders will be identified based on airway remodeling status, biomarkers in tissue and secretion samples and on the reduction of the need of surgery through Lund-Kennedy endoscopic score, Lund-Mackay score and patient's clinical status in the 6th, 12th and 36th month after the initiation of treatment.\n\nRegarding the unified airway system, nose and pharyngeal microbiome will be evaluated before and after 52 weeks of mepolizumab treatment in patients with nasal polyps whereas in patients with nasal polyps and asthma bronchus microbiome will also be evaluated. Lung samples will help gain information about the inflammatory profile and local microbiome of CRSwNP patients with asthma through molecular and cellular assays. The human Pharyngeal Microbiome might play a protective role in Respiratory Tract Infections and it has been reported that the microbiome provides critical signals to promote maturation of immune cells and differentiation of the tissue. Thus, we will make an effort to correlate microbiome of various locations with clinical and laboratory characteristics of responders and non-responders to mepolizumab treatment.",[27,343],[81,344,343],"2024-03-07",{"date":523,"type":34},"2024-03-08",{"date":525,"type":34},"2024-02-23",{"date":527,"type":21},"2027-03-01",{"name":529,"class":99},"Aristotle University Of Thessaloniki",{"id":531,"slug":532,"hasResults":11,"nctId":533,"briefTitle":534,"officialTitle":534,"acronym":535,"eligibilityCriteria":536,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":537,"targetDuration":4,"studyType":22,"phases":539,"briefSummary":540,"conditions":541,"keywords":542,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":548,"lastUpdatePostDateStruct":549,"startDateStruct":551,"completionDateStruct":553,"leadSponsor":554,"locationsCount":4},"100532792","proof-of-concept-of-remote-management-of-chronic-inflammatory-airway-diseases-for-patient-empowerment-100532792","NCT06217419","Proof of Concept of Remote Management of Chronic Inflammatory Airway Diseases for Patient Empowerment","PRECISION","Inclusion Criteria:\n\n* ≥ 18 years\n* affected by chronic rhino sinusitis and\u002For asthma\n* not diagnosed with head and neck or lung cancer\n* no cardiovascular or metabolic uncontrolled diseases\n* if woman, not pregnant or breastfeeding\n* able to understand and sign the informed consent and to perform procedures required by the protocol\n\nExclusion Criteria:\n\n* \\\u003C 18 years\n* affected by cancer or uncontrolled diseases\n* pregnant or breastfeeding women\n* uncompleted clinical history data\n* unable to sign the informed consent or to perform procedures required by the protocol",{"count":538,"type":21},136,[110],"Chronic rhinosinusitis (CRS) is a multifactorial disease characterized by persistent symptomatic inflammation of the mucosa of the nose and paranasal sinuses, with (CRSwNP) or without (CRSsNP) the presence of nasal polyps. It affects 5 to 12% of the general population. CRS is often associated with asthma, which has a prevalence of 4% in the general population, reaching 30%-70% among patients with CRS. The current standard clinical evaluation of patients for both diseases has two main components: a subjective one (self-assessment provided by the patient), based mainly on the PROMs (Patient-Reported Outcome Measures) questionnaire, and an objective one (formulated by the clinician). Questionnaires present accuracy and response rate problems that have been investigated in the literature, finding that short questionnaires, incentives, personalization of questionnaires as well as repeat sending strategies or telephone reminders have a beneficial impact on the quantity and quality of responses. Today there are many new channels provided by technology. Among them, AI chatbots have been used in a variety of healthcare domains such as medical consultations, disease diagnosis, mental health support and, more recently, risk communications for the COVID-19 pandemic, and can offer a better way to collect questionnaires. At the same time, the recent technical solution of new non-invasive techniques for RFID radio frequency identification devices allows subjective reports to be accompanied with objective reports.\n\nThe PRECISION project aims to evaluate systems for home monitoring of chronic rhinosinusitis (CRS) and asthma, two highly prevalent chronic diseases. The frequent association between the two pathological conditions is a further argument in support of the rationality of a common approach.\n\nAs regards the collection of PROMs, three acquisition channels will be compared: i) AI Chatbots; ii) PhoneBot; iii) Mobile application. Data will be analyzed in relation to patient profiles to define the quality and quality of response.\n\nRegarding objective evaluation, the project will investigate the efficiency of objective remote airflow measurements for both upper (CRS) and lower (asthma) airways using dedicated non-invasive systems based on RFID technology.",[27,343],[543,544,545,546,343,547],"Chatbot","Patient empowerment","Chronic rhinosinusitis","Airway diseases","Patient-reported outcome measures (PROM)","2024-01-19",{"date":550,"type":34},"2024-01-22",{"date":552,"type":21},"2024-02",{"date":219,"type":21},{"name":555,"class":99},"Azienda Ospedaliero Universitaria di Sassari"]