[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"eosinophilic-asthma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:eosinophilic-asthma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,49,77,108,138,172],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100617825","phase-2-a-study-of-kt-621-administered-orally-to-adult-participants-with-moderate-to-severe-eosinophilic-asthma-100617825",false,"NCT07323654","A Study of KT-621 Administered Orally to Adult Participants With Moderate to Severe Eosinophilic Asthma","A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Dose-ranging Study Investigating the Efficacy and Safety Profile of KT-621 Administered Orally to Adult Participants With Uncontrolled Moderate to Severe Eosinophilic Asthma","BREADTH","Inclusion Criteria:\n\n* Must be 18 years old (or the legal age of consent in the jurisdiction in which the study is taking place) to 75 years of age, inclusive, at the time of signing the ICF.\n* Must have a physician diagnosis of asthma for at least 1 year prior to the Screening visit.\n* Must be on a stable regimen of medium- to high- dose inhaled corticosteroid (ICS), in combination with a long-acting β2-agonist (LABA). The regimen may include additional controller medications used for at least 12 weeks, at a stable dose and regimen, with no change in the dose or frequency of administration for at least 4 weeks prior to the Screening visit and between the Screening and Baseline visits.\n* Must have a pre-bronchodilator FEV1 40 to 80% of predicted normal at the Screening and Baseline visits, prior to randomization.\n* Must have an ACQ-5 score ≥ 1.5 at the Screening and Baseline visits, prior to randomization.\n* Must have a FeNO level of ≥ 25 ppb at the Screening and Baseline visits.\n* Must have a demonstrated evidence of reversible airway obstruction by post-bronchodilator (albuterol\u002Fsalbutamol) reversibility of FEV1 ≥12% and ≥200 mL at Screening.\n* Must have an absolute blood eosinophil count must be ≥ 0.30 × 10\\^9\u002FL at Screening.\n* Must have a documented history of at least 1 asthma exacerbation requiring either treatment with systemic corticosteroids (intramuscular, intravenous, or oral) and\u002For hospitalization or an emergency\u002Furgent medical care visit for acute asthma worsening within the past 52 weeks prior to Screening.\n* Must agree to contraceptive requirements in compliance with the clinical study and local requirements.\n* Must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, other study-related procedures, and questionnaires, including completing the electronic diary (e-diary), for the duration of the study as required by the study protocol.\n\nExclusion Criteria:\n\n* Must not have any clinically significant pulmonary disease other than asthma.\n* Must not have had an asthma exacerbation, requiring either treatment with systemic corticosteroids (intramuscular, intravenous, or oral) and\u002For hospitalization or an emergency\u002Furgent medical care visit for acute asthma worsening, at any time from 4 weeks prior to the Screening visit up to and including the Baseline visit.\n* Must not have any other clinically significant disease, condition, or medical history that, in the opinion of the Investigator, would interfere with participant safety, study evaluations, and\u002For study procedures.\n* Must not be pregnant or breastfeeding; must not be a woman planning to become pregnant or breastfeed during the study.\n* Must not have results from clinical laboratory safety tests that are outside the local reference range at Screening.\n* Must not have been dosed with any investigational drug or device in a clinical study within 8 weeks or 5 half-lives (whichever is longer) of KT-621 administration.\n* Must not have any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results.\n* Must not be a current smoker of nicotine\u002Ftobacco as well as non-nicotine products, have a smoking history of ≥ 10 pack years, or use vaping products, including electronic cigarettes. Former smokers with a smoking history of \\\u003C 10 pack years and users of vaping or e-cigarette products must have stopped for at least 26 weeks prior to the Screening visit.\n* Must not have a known sensitivity to any of the components of KT-621.\n* Must not be a member of the investigational team or his\u002Fher immediate family.","ALL","18 Years","75 Years",{"count":21,"type":22},264,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This Phase 2b study is designed to evaluate the safety and efficacy of KT-621 in participants with uncontrolled moderate to severe eosinophilic asthma.\n\nThe main goals of this study are to investigate how effective KT-621 is at treating uncontrolled moderate to severe eosinophilic asthma, the safety and tolerability of KT-621, and how KT-621 behaves in the body.",[28],"Eosinophilic Asthma",[30,31,32,33,34,35],"kt-621","stat6 degrader","stat6","targeted protein degrader","Phase 2","phase 2b","RECRUITING","2026-06-24",{"date":39,"type":40},"2026-06-29","ACTUAL",{"date":42,"type":40},"2026-01-28",{"date":44,"type":22},"2027-12",{"name":46,"class":47},"Kymera Therapeutics, Inc.","INDUSTRY",58,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":76},"100641542","phase-4-fasenra-an-asthma-study-100641542","NCT07654842","Fasenra: An Asthma Study","Fasenra Demonstrates Durability Over the Full 8-week Treatment Period","Inclusion Criteria:\n\n1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF.\n2. At least 18 years of age at the time of signing the informed consent at Visit 1.\n3. Documented asthma diagnosis ≥12 months prior to Visit 1. This may be documented by physician-diagnosis or by documented pharmacy records.\n4. Treated with a daily ICS-containing maintenance inhaler for asthma at a stable dose for ≥3 months prior to Visit 1. This inhaler may contain ICS alone, or in combination with a LABA or LABA-LAMA. The prescribed inhaler must be compatible with a study-provided EMM (see Appendix A).\n5. Prescribed a SABA-containing reliever inhaler, AND willing to use study-provided ICS-SABA reliever with EMM provided by the study.\n6. Prescribed benralizumab for severe eosinophilic asthma for ≥6 months AND has had ≥4 benralizumab doses (3 loading doses + at least 1 8-week dosing interval).\n\nExclusion Criteria:\n\n1. Current smoker (including tobacco, vaping, and marijuana). Former smokers must have stopped ≥6 months prior to Visit 1.\n2. Has a known, preexisting, clinically significant cardiac, endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, hematological, or any other system abnormalities that are uncontrolled with standard treatment, which, in the investigator's opinion, would compromise the participant's safety, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence.\n3. History of use of any biologic therapy for asthma (other than benralizumab) within 5 half-lives or 5 months, whichever is longer, before Visit 1.\n4. A severe asthma exacerbation within 4 weeks of Visit 1. For this study, a severe asthma exacerbation is defined as an episode of worsening asthma symptoms that result in at least one of the following:\n\n   * Use of systemic corticosteroids for at least 3 consecutive days (or a single depo-injectable dose of corticosteroids)\n   * An inpatient hospitalization (defined as admission to an inpatient facility and\u002For evaluation and treatment in a healthcare facility for ≥24 hours) due to asthma\n   * An emergency department visit (defined as evaluation and treatment for \\\u003C24 hours in an emergency department or urgent care) due to asthma that required systemic corticosteroids (as per above)\n5. Current enrollment in an asthma-related clinical trial.\n6. Any known history of adverse reactions to budesonide-albuterol.",{"count":57,"type":22},40,[59],"PHASE4","The goal of this observational study is to learn more about the effectiveness of benralizumab (Fasenra, 30 mg every 8 weeks) in maintaining asthma control in people with severe eosinophilic asthma.\n\nParticipants will have electronic medication monitors fitted to their usual maintenance inhaler, as well as a study-provided anti-inflammatory rescue inhaler, albuterol-budesonide (AirSupra). These monitors will track when each inhaler is used. Participants will also upload time-stamped photos of their benralizumab administration to their electronic medical records.",[28,62,63,64],"Severe Asthma","Severe Eosinophilic Asthma","Asthma","NOT_YET_RECRUITING","2026-06-12",{"date":68,"type":40},"2026-06-17",{"date":70,"type":22},"2026-07-01",{"date":72,"type":22},"2028-01-01",{"name":74,"class":75},"Endeavor Health","OTHER",1,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":85,"maxAge":19,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":90,"conditions":91,"keywords":92,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"100573746","phase-3-randomised-clinical-trial-to-investigate-efficacy-and-safety-of-benralizumab-30-mg-sc-as-an-add-on-therapy-in-uncontrolled-eosinophilic-asthma-patients-treated-with-medium-dose-ics-laba-compared-to-conventional-escalation-to-high-dose-ics-laba-treatment-100573746","NCT06750289","Randomised Clinical Trial to Investigate Efficacy and Safety of Benralizumab 30 mg SC as an add-on Therapy in Uncontrolled Eosinophilic Asthma Patients Treated With Medium-dose ICS-LABA Compared to Conventional Escalation to High-dose ICS-LABA Treatment","BRISOTE: A Multicentre, Randomised, Double-Blind, Parallel Group, Active-Controlled, Phase 3b Study to Evaluate the Efficacy and Safety of Benralizumab 30 mg SC in Eosinophilic Asthma Patients Uncontrolled on Medium-Dose Inhaled Corticosteroid Plus Long-acting β2-Agonist.","BRISOTE","Inclusion Criteria:\n\n* Written informed consent\n* Participant must be 12 to 75 years of age\n* Documented history of physician-diagnosed asthma requiring treatment with at least medium-dose ICS (\\> 250 μg fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit (V) 1.\n* Documented treatment with medium-dose ICS and LABA for at least 3 months prior to Visit 1 with or without additional asthma controllers (excluding oral corticosteroids).\n* Weight of ≥ 35 kg.\n* Pre-Bronchodilator (BD) Forced expiratory volume in 1 second (FEV1) of ≤ 90% predicted\n* Documented at least 2 asthma exacerbations in the 12 months prior to the date of informed consent.\n* ACQ-6 score ≥ 1.5 at Visit 1, plus at least once in the run-in period (from V2 to V3) and at V3.\n* Evidence of asthma as documented by excessive variability in lung function, as defined in the protocol.\n* Peripheral blood eosinophil count of ≥ 150 cells\u002FμL, as defined in the protocol.\n* At least 70% compliance with usual asthma controller ICS-LABA during run-in period (from Visit 2 to Visit 3) based on asthma daily diary.\n\nExclusion Criteria:\n\n* Important pulmonary disease other than asthma at the discretion of the investigator, or ever been diagnosed with pulmonary or systemic disease, other than asthma, which are associated with elevated peripheral eosinophil counts.\n* Asthma exacerbation requiring use of Systemic corticosteroids (SCS), or acute upper\u002Flower respiratory infection that requires antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening\u002Frun-in period\n* Any unstable disorder that in the opinion of the investigator could affect the study according to the study protocol.\n* Clinically significant chronic or ongoing active infections requiring systemic treatment (at investigator's discretion)\n* Concurrent participation in another clinical study with an IP or a post-authorisation safety study.\n* History of alcohol or drug abuse within 12 months prior to the date informed consent is obtained.\n* Current smokers or former smokers with a smoking history ≥ 10 pack-years. Former smokers must have stopped for at least 6 months prior to Visit 1 to be eligible.","12 Years",{"count":87,"type":22},400,[89],"PHASE3","This study evaluates the efficacy and safety of benralizumab as an add-on therapy in uncontrolled eosinophilic asthma participants treated with medium-dose ICS-LABA compared to the conventional treatment step of escalation of inhaled therapy to high-dose ICS-LABA.",[28],[93,94,95,96,97],"Eosinophilic Asthma;","Benralizumab,","FASENRA,","Medium-Dose Inhaled Corticosteroid,","Long-acting β2-Agonist","2026-05-12",{"date":100,"type":40},"2026-05-13",{"date":102,"type":40},"2025-03-28",{"date":104,"type":22},"2028-11-03",{"name":106,"class":47},"AstraZeneca",160,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":23,"phases":118,"briefSummary":119,"conditions":120,"keywords":121,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":76},"100612208","phase-2-a-multi-dose-study-on-the-safety-and-efficacy-of-self-administered-intranasal-ad17002-treatment-for-eosinophilic-asthma-100612208","NCT07250594","A Multi-dose Study on the Safety and Efficacy of Self-administered Intranasal AD17002 Treatment for Eosinophilic Asthma","A Phase II, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multiple-dose Study to Investigate the Safety and Efficacy of 3-month AD17002 Treatment in Adults With Inadequately Controlled Moderate to Severe Eosinophilic Asthma","Inclusion Criteria:\n\n* Aged 18 to 80 on the day of signing the informed consent.\n* With a diagnosis of asthma for at least 6 months.\n* With pre-BD FEV1 ≥ 50% of the predicted value at the Screening visit (see section 18.6 for calculation of the predicted value for FEV1).\n* Having blood eosinophil counts ≥ 150 cells\u002FμL at the Screening visit.\n* Participants who meet any of the following asthma criteria at the Screening visit:\n\n  * Moderate asthma-1 (i.e., step 3 in asthma treatment steps in adults and adolescents from 2025 GINA guideline):\n  * Moderate asthma-2 (i.e., step 4 in asthma treatment steps in adults and adolescents from 2025 GINA guideline):\n  * Severe asthma (i.e., step 5 in asthma treatment steps in adults and adolescents from 2025 GINA guideline, except for biologic therapies):\n\nExclusion Criteria:\n\n* A current smoker or quit smoking ≤ 0.5 years at Screening visit.\n* With serious underlying chronic illness or severe systemic disease, including but not limited to systemic lupus erythematosus, at the investigator's discretion.\n* With a current malignancy or previous history of cancer in remission for less than 5 years prior to Screening visit (Subject will not be excluded if he\u002Fshe had localized carcinoma of the skin that was resected for cure).\n* With chronic heart failure in New York Heart Association class III to IV.\n* With clinically severe lung disease, including but not limited to cystic fibrosis, chronic bronchitis (chronic obstructive pulmonary disease other than asthma), chronic respiratory infection, lung cancer, current infection, active tuberculosis infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or diagnoses of emphysema.\n* With arrhythmia, myocardial infarction, or stroke within the last 3 months prior to the Screening visit.\n* With a recent respiratory tract infection within 4 weeks prior to the Screening visit.\n* Received chronic oxygen therapy within one month prior to the Screening visit.\n* With any nasal conditions that could interfere with drug absorption or confound the efficacy or safety assessments.\n* Immunosuppressive treatment, including but not limited to methotrexate, troleandomycin, cyclosporine, and azathioprine within 3 months prior to the Screening visit and throughout the study.\n* Use of systemic corticosteroids (including regular oral corticosteroids or intramuscular long-acting depot corticosteroids) at daily average doses greater than 7.5 mg prednisone or equivalent for the past 3 months prior to the Screening visit.\n* Having or planning to be vaccinated with live (attenuated) vaccine within 1 month prior to the Screening visit and throughout the study.\n* Having received immunotherapy including but not limited to monoclonal antibodies, within 3 months prior to the Screening visit and throughout the study.\n* Having previously received AD17002.\n* Having received other IP or investigational intervention (non-AD17002), including investigational formulations of marketed products, within the past 30 days or 5 half-lives of the medication, whichever is longer, prior to the Screening visit.\n* Requiring add-on biologic therapy, such as anti-IgE, anti-IL-5\u002F5R, anti-IL-4Rα, and anti-thymic stromal lymphopoietin treatment.\n* Having experienced a life-threatening asthma attack or an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalization due to asthma, or treatment with high-dose systemic corticosteroids (prednisolone ≥ 40 mg\u002Fday or equivalent for ≥ 5 days) within 1 month prior to the Screening visit.\n* Having a history of anaphylaxis with cardiorespiratory symptoms, triggered by prior immunotherapy, an unknown cause, or an inhalant allergen.\n* Being pregnant or breastfeeding.\n* Planning to become pregnant or breastfeed throughout the study.\n* A known history of allergy, hypersensitivity, or intolerance to any component of IP, rescue medications, or self-injectable epinephrine.\n* Any clinically significant abnormalities in physical examination, vital signs, hematology, biochemistry, or urinalysis that, in the investigator's opinion, may pose a risk to the patient's safety, affect study outcomes, or hinder the patient's ability to complete the study.","80 Years",{"count":117,"type":22},126,[25],"1. Eosinophilic asthma, a type 2 immune disorder, often involves the excessive production of type 2 cytokines.\n2. Excessive Type 2 cytokines lead to chronic inflammation, airway hyperresponsiveness, and airflow obstruction.\n3. AD17002 is an intranasal self-applicable immunomodulator.\n4. AD17002 is safe and tolerable in all studied clinical trials.\n5. AD17002 elevates local type-1 interferon levels and promotes epithelial healing.\n6. Type-1 interferons have been demonstrated to restore immune balance and reduce eosinophilic infiltration.\n\nAD17002, an innate immune modulator, is likely to be effective as an add-on therapy to control poorly managed moderate to severe eosinophilic asthma.",[28],[122,123,124,125,126,127,128],"Eosinophile","Type 1 interferon","Type 2 cytokines","Immunomodulator","eosinophilic asthma","intranasal","self-applicable","2025-11-18",{"date":131,"type":40},"2025-11-26",{"date":133,"type":22},"2025-12",{"date":135,"type":22},"2026-12",{"name":137,"class":47},"Advagene Biopharma Co. Ltd.",{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":146,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":147,"targetDuration":4,"studyType":148,"phases":4,"briefSummary":149,"conditions":150,"keywords":153,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":170,"locationsCount":4},"100586161","eosinophil-subpopulations-in-eosinophilic-associated-diseases-100586161","NCT06911775","Eosinophil Subpopulations in Eosinophilic-associated Diseases","Exploring Inflammatory and Regulatory Eosinophil Subpopulations: the Path to Precision Medicine for the Treatment of Eosinophilic-associated Diseases","IREOS","Inclusion Criteria:\n\n\\- For inclusion in the study subjects should fulfill the following criteria based on local regulations:\n\nPatients with Asthma, or EGPA or HES:\n\n1. Age between 18 and 75 years at the time of signing the informed consent\n2. Patients with EA, EGPA or HES\n3. Provision of signed and dated written informed consent form prior to any mandatory study procedures, sampling and analysis.\n\nHealthy donors:\n\n1\\. Age between18 and 75 years healthy donors\n\nExclusion Criteria:\n\n* Subjects should not enter the study if any of the following exclusion criteria are fulfilled:\n\n  1. Presence of other chronic pulmonary diseases including COPD\n  2. Presence of other chronic immuno-mediated inflammatory diseases\n  3. Treatment with oral prednisone or equivalent \\> 7.5 mg\u002Fday\n  4. Treatment with long-acting depot corticosteroids in the last three months\n  5. Use of immunosuppressive medications (cyclosporine A; azathioprine; methotrexate; mycophenolate mofetil)\n  6. Receipt of live attenuated vaccines 30 days prior to the enrollment\n  7. Acute upper or lower respiratory infections within 30 days prior to the date informed consent is obtained or during the screening\u002Frun-in period.\n  8. A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with, or has failed to respond to, standard of care therapy\n  9. Subjects who are pregnant or breastfeeding\n  10. Current smoking\n  11. Any clinically significant abnormal findings in physical examination, vital signs, hematology, or clinical chemistry during screening period, which in the opinion of the investigator may put the patient at risk of his\u002Fher participation in the study, or may influence the results of the study, or the patient\\'s ability to complete entire duration of the study.\n  12. Concurrent enrolment in another interventional or post-authorization safety study.",true,{"count":107,"type":22},"OBSERVATIONAL","This single-center, non-commercial study will involve 160 participants (80 with eosinophilic asthma (EA), 30 with eosinophilic granulomatosis with polyangiitis (EGPA), 25 with hypereosinophilic syndrome (HES), and 25 healthy donors) to investigate eosinophil subpopulations in these diseases. The study will run from Q4 2024 to Q4 2026.\n\nObjectives:\n\nPrimary: To verify two eosinophil subpopulations (iEos and rEos) in EGPA and HES and analyze the role of type 2 cytokines on their plasticity.\n\nSecondary: Compare iEos proportion between different eosinophilic diseases and correlate with disease severity.\n\nExploratory: Assess the effect of mepolizumab on eosinophil subpopulations in vitro.\n\nPopulation: Adults aged 18-75 with EA, EGPA, or HES, and healthy controls. EA patients must have \\>300 eosinophils\u002FmcL, EGPA requires asthma + eosinophilia + other specific features, and HES requires high eosinophil counts (\\>1500 cells\u002FmL).\n\nMethods: Data will be analyzed using Mann-Whitney U, ANOVA, and Spearman correlation tests, with results presented as mean ± SEM.\n\nThis study will help explore eosinophil behavior in eosinophilic diseases and evaluate mepolizumab's effects on these cells.",[28,151,152],"Eosinophilic Granulomatosis With Polyangiitis (EGPA)","Hypereosinophilic Syndrome (HES)",[154,155,156,157,158,159,160,161,162,163],"Eosinophils","EGPA","HES","EA","Eosinophilic asthma","Eosinophil subpopulations","Flowcytometry","Biomarker","Asthma severity","EGPA severity","2025-03-27",{"date":166,"type":40},"2025-04-04",{"date":168,"type":22},"2025-04",{"date":135,"type":22},{"name":171,"class":75},"University of Florence",{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":146,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":179,"targetDuration":181,"studyType":148,"phases":4,"briefSummary":182,"conditions":183,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":76},"100403869","prospective-registry-of-eosinophilia-with-respiratory-manifestations-with-translational-research-identifying-and-characterizing-eosinophils-100403869","NCT04538937","Prospective Registry of Eosinophilia With Respiratory Manifestations With Translational Research Identifying and Characterizing Eosinophils","PROMETHEos","Inclusion Criteria:\n\n* age ≥ 18 years\n* documented blood eosinophilia ≥ 300 cells\u002Fµl\n* present tissue damage of the respiratory tract caused by eosinophils\n\nExclusion Criteria:\n\n* age \\\u003C 18 years\n* pregnancy\n* dementia\n* incapacitated patients",{"count":180,"type":22},300,"10 Years","Introduction: The etiology and therapy of eosinophilic lung diseases are still poorly understood. For individual forms of disease, such as eosinophilic asthma or eosinophilic granulomatosis with polyangiitis (EGPA), new therapeutic approaches exist that block the interleukin IL-5 or the IL-5 receptor. Eosinophilic manifestations of the respiratory tract can exclusively affect the lungs or occur as part of a systemic disease. The manifestations partially overlap and are clinically difficult to differentiate (e.g. eosinophilic asthma, Samter Triad, EGPA or hypereosinophilic syndrome (HES)). It is now known that blood eosinophil counts correlate with the level of eosinophils recruited to the airways. However, it is still unclear whether there is a blood eosinophilia without clinical relevance or whether there is a risk of organ damage (e.g. in HES). Hence, different subtypes of eosinophils with different polarization are discussed.\n\nAim of the study: A registry of patients with eosinophilia and respiratory manifestation will be established at the University Hospital of Innsbruck. The course of disease will be evaluated prospectively in a non-interventional study. This study stands on three main clinical pillars with focus on further characterization of eosinophilic cells:\n\n1. Patients will be included who switch from a previous application of the anti-IL5 antibody mepolizumab (production and administration of the injection from lyophysate through the doctor) to the pre-mixed pen (self-injection at home).\n2. Furthermore, special focus is set on patients suffering from the so-called Samter Triad. In these patients, the control of asthma, nasal polyps and NSAID intolerance will be examined in an interdisciplinary fashion during the course of treatment.\n3. Previous clinical studies at our Department indicate that some patients with severe eosinophilic asthma or Samter Triad could represent a mono-organic or limited manifestation of lymphoid HES. This hypothesis is tested by measuring additional chemokines, somatic mutations and FACS parameters in this subgroup to verify a clonal disease.\n\nIn addition, translational research will differentiate resident and inflammatory eosinophilic granulocytes by FACS analysis and further characterize them by fluorescence microscopy, electron microscopy, gene chip analysis and lipidomics, in the above-mentioned diseases and in healthy controls, respectively.\n\nPatients and methods: All patients suffering from eosinophilia with pulmonary involvement who are diagnosed with eosinophilic asthma, EGPA, Samter Triad, HES, and eosinophilic pneumonia with signed consent are included in the prospective registry. Provided, that they are registered at the outpatient department of pneumology, ENT, haematology or allergology at the University Hospital Innsbruck. The investigators will collect laboratory analyses, lung function, imaging, bone marrow biopsies, ENT findings and allergological findings over the course of the study. Furthermore, additional blood tubes are collected during routine blood tests, which are used to identify and characterize subtypes of eosinophilic granulocytes.\n\nRisks for patients: No additional examinations, blood sampling or invasive measures are required for the patient. Thus, there is no additional risk for study participants.\n\nRisks for control subjects: In order to be able to compare our results with the healthy population, volunteer subjects are recruited. After consent has been given, a blood sample is taken. Despite the low risk, it is theoretically possible that blood sampling may be accompanied by non-severe complications (such as hematoma, infection).\n\nBenefits: The investigators expect new insights into phenotype and therapy of patients with eosinophilic manifestations of the respiratory tract.",[28,184,185,186,187],"EGPA - Eosinophilic Granulomatosis With Polyangiitis","Samter Triad","HES - Hypereosinophilic Syndrome","Eosinophilic Pneumonia","2020-09-02",{"date":190,"type":40},"2020-09-04",{"date":192,"type":40},"2020-02-26",{"date":194,"type":22},"2030-02-26",{"name":196,"class":75},"Medical University Innsbruck"]