[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":64},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100559055","phase-2-a-phase-ii-study-of-ensifentrine-in-non-cystic-fibrosis-bronchiectasis-100559055",false,"NCT06559150","A Phase II Study of Ensifentrine in Non-Cystic Fibrosis Bronchiectasis","A Phase II, Randomized, Double-Blind, Placebo- Controlled Study of Ensifentrine in Subjects With Non-Cystic Fibrosis Bronchiectasis","Inclusion Criteria:\n\n* Males are eligible to participate if they agree to use contraception as described in the contraceptive guidance from Screening and throughout the study and for at least 30 days after the last dose of blinded study medication\n* Females are eligible to participate if they are not pregnant, not breastfeeding, and 1 of the following conditions apply:\n\n  1. Not a woman of childbearing potential (WOCBP) OR\n  2. A WOCBP who agrees to follow the contraceptive guidance from Screening throughout the study and for at least 30 days after the last dose of blinded study medication\n* Clinical history consistent with bronchiectasis (cough, chronic sputum production, and\u002For recurrent respiratory infections) confirmed by chest CT demonstrating bronchiectasis affecting 1 or more lobes. Confirmation may be based on prior chest CT within the prior 5 years; subjects whose past CT image records are not available will require chest CT scan during screening Notes: If a subject has no clinical history consistent with bronchiectasis, they may not be re-screened\n* Current sputum producer with a history of chronic expectoration and able to provide sputum sample spontaneously at the clinic during screening\n* ≥ 1 documented pulmonary exacerbation defined by an antimicrobial prescription (i.e., antibiotic or antiviral) by a physician for the signs and symptoms of respiratory infections in the past 12 months before screening\n* Capable of using the study nebulizer correctly\n* Ability to perform acceptable spirometry in accordance with American Thoracic Society and European Respiratory Society guidelines as assessed by the Investigator\n\nExclusion Criteria:\n\n* A diagnosis of COPD or a primary diagnosis of asthma, as judged by the investigator\n* Bronchiectasis due to cystic fibrosis, primary hypogammaglobulinemia common variable immunodeficiency, severe immunodeficiency, or requirement for treatment with intravenous immunoglobulin\n* Current smoker defined as by the Centers for Disease Control and Prevention (CDC)\n* Meets both of the following\n\n  1. Former cigarette smokers with a history of cigarette smoking ≥ 10 pack years at Screening \\[number of pack years = (number of cigarettes per day \u002F 20) × number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)\\]. Pipe and\u002For cigar use cannot be used to calculate pack-year history. Former smokers are defined as those who have stopped smoking for at least 6 months prior to Screening AND\n  2. Evidence within 1 year prior to randomization of obstructed lung function as shown by forced expiratory volume in 1 second (FEV1)\u002Fforced vital capacity (FVC) ratio of \\\u003C 0.70\n* A diagnosis of primary ciliary dyskinesia (PCD) is not exclusionary. Subjects with a diagnosis of PCD are permitted to be enrolled, but the proportion of subjects with PCD enrolled in the study may be limited\n* Current treatment for nontuberculous mycobacterial lung infection, allergic bronchopulmonary aspergillosis, or tuberculosis\n* Presence of acute exacerbation or acute infection that required acute treatment within 28 days of randomization\n* Use of the following prohibited medications within the designated time periods:\n\n  1. Chronic, systemic immunomodulatory agents for any chronic indication (including but not limited to the following: methotrexate, systemic corticosteroids, see adalimumab, azathioprine, dupilumab, cyclosporine, hydroxychloroquine, etc.) within 90 days prior to signing the ICF\n  2. CFTR modulators (e.g., ivacaftor, lumacaftor, tezacaftor) within 1 week prior to signing the ICF\n  3. Theophylline and oral PDE4 inhibitors (e.g., roflumilast, apremilast, crisaborole) within 48 hours prior to signing the ICF\n  4. Ohtuvayre at any time prior to signing the ICF\n* Initiated or altered therapy within 90 days prior to randomization with:\n\n  1. oral or inhaled antibiotics as chronic treatment (including macrolides)\n  2. Cyclic antibiotics: defined as prescribed regular cycles of on antibiotic treatment and off antibiotic treatment (for example, but not limited to, 28 days on an antibiotic and 28 days off an antibiotic). Note: Subjects on cyclic antibiotics must be actively taking antibiotics for at least 7 days prior to randomization through the day of randomization\n  3. Dipeptidyl peptidase 1 (DPP1) or cathepsin C (CatC) inhibitor (e.g., brensocatib)\n* Initiated or altered therapy with ICS within 4 weeks prior to randomization\n* Unable to withhold short-acting beta-agonists or short-acting muscarinic antagonists for ≥ 4 hours prior to spirometry\n* Significant hemoptysis (≥ 300 mL or requiring blood transfusion) within 6 weeks prior to randomization\n* Currently participating in or scheduled to participate in an intensive pulmonary rehabilitation program (a maintenance rehabilitation program is allowed if their schedule and procedure will be consistent for the duration of the study)\n* Current or chronic history of unstable liver disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices or persistent jaundice, cirrhosis, or known hepatic or biliary abnormalities except for Gilbert syndrome or asymptomatic gallstones Note: Chronic stable hepatitis B and C is not exclusionary if the subject otherwise meets study entry criteria\n* History of or current malignancy of any organ system, treated or untreated within the past 5 years, except for localized basal or squamous cell carcinoma of the skin\n* Estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\n* Alanine aminotransferase (ALT) ≥ 2 × upper limit of normal (ULN), aspartate aminotransferase (AST) ≥ 2 × ULN, alkaline phosphatase and\u002For bilirubin \\> 1.5 × ULN (isolated bilirubin \\> 1.5 × ULN is acceptable only in subjects with a diagnosis of Gilbert's syndrome)\n* Participation in any other interventional, clinical studies (drugs or devices) within 30 days, or 5 half-lives, whichever is longer, prior to signing the ICF\n* Intolerance of or hypersensitivity to ensifentrine or any of its excipients\u002Fcomponents\n* Current or history of drug or alcohol abuse within the past 5 years\n* Significantly abnormal ECG finding","ALL","18 Years","80 Years",{"count":20,"type":21},284,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study is a randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of ensifentrine inhalation suspension (3 mg) delivered twice daily via standard jet nebulizer up to 52 weeks, compared to placebo, in participants with non-cystic fibrosis bronchiectasis (NCFBE).",[27],"Non-cystic Fibrosis Bronchiectasis","RECRUITING","2026-08-03",{"date":31,"type":32},"2026-08-06","ACTUAL",{"date":34,"type":32},"2024-09-11",{"date":36,"type":21},"2027-09-24",{"name":38,"class":39},"Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA","INDUSTRY",51,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":18,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100460046","phase-2-effect-of-ensifentrine-on-sputum-markers-of-inflammation-in-copd-100460046","NCT05270525","Effect of Ensifentrine on Sputum Markers of Inflammation in COPD","A Randomized, Double-Blind, Placebo-Controlled, Two-period Cross-over Study of the Effect of Ensifentrine on Sputum Markers of Inflammation in Patients With COPD","Inclusion Criteria:\n\nMale and female patients 40-80 years of age with a history of cigarette smoking ≥10 pack years and an established clinical history of COPD as defined by the American Thoracic Society (ATS)\u002FEuropean Respiratory Society (ERS) guidelines with symptoms compatible with COPD.\n\nCOPD Severity: Pre- and Post-albuterol\u002Fsalbutamol FEV1\u002FFVC ratio of \\\u003C0.70; Post-albuterol\u002Fsalbutamol FEV1 ≥30 % and ≤80% of predicted normal calculated using the National Health and Nutrition Examination Survey III.\n\nRegular use of bronchodilator COPD therapy, in any form (e.g., LAMA, LABA, LAMA+LABA, LAMA+LABA+ICS), for at least 4 weeks prior to Screening and agrees to use study supplied COPD Maintenance Therapy once daily through the final study visit.\n\nCapable of using the jet nebulizer correctly and complying with all study restrictions and procedures. Ability to perform acceptable spirometry in accordance with ATS\u002FERS guidelines. Ability to produce sputum samples during the induced sputum procedure.\n\nExclusion Criteria:\n\nAny clinically diagnosed lung disease other than COPD such as current asthma, diffuse interstitial lung diseases, cystic fibrosis, or clinically significant bronchiectasis as determined by the Investigator. Hospitalizations for COPD, pneumonia, or Corona Virus Disease 2019 (COVID-19) in the 12 weeks prior to Screening; or a positive COVID-19 test result indicating an active infection at Screening.\\*Note: Patients with a positive COVID-19 antibody test from a past exposure who do not exhibit symptoms of an active COVID-19 infection are eligible to participate in the study. \\*A COVID-19 test may be performed at the visit or within 7 days prior to the visit (or as required locally). Asymptomatic patients with a positive COVID-19 test result indicating an active infection \\\u003C 30 days prior to Screening or at Screening may be re-screened for eligibility after 30 days (or in accordance with local requirements).\n\nAlanine aminotransferase (ALT) ≥ 2 x upper limit of normal (ULN), alkaline phosphatase and\u002For bilirubin \\> 1.5 x ULN (isolated bilirubin \\>1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin \\\u003C35%). HIV infection or other immunodeficiency. History of cancer within the last 5 years, except for well-treated basal cell carcinoma and squamous cell carcinoma of the skin.\n\nAny clinically significant 12-lead electrocardiogram abnormalities at screening or baseline, including corrected QT interval by Fridericia's correction method \\>450 ms for males or \\>480 ms for females or history of significant cardiac dysrhythmia, including long QT syndrome.\n\nKnown history of poor outcomes with sputum induction. Known hypersensitivity to ensifentrine or other medications used in the study (e.g., albuterol or salmeterol). Not suitable for study supplied once daily COPD Maintenance Therapy per label warnings and contraindications.\n\nTaking prohibited medication. Prior receipt of Ohtuvayre or blinded nebulized study medication in an ensifentrine (RPL554) study. Note: Other ensifentrine formats (e.g., DPI, MPI) are not exclusionary.\n\nUse of an experimental drug within 30 days or 5 half-lives of Screening, whichever is longer, and\u002For participation in a study treatment-free follow-up phase of a clinical trial within 30 days prior to Screening. Use of an experimental medical device or participation in a follow-up phase of an experimental medical device clinical trial within 30 days prior to Screening. Any other medical history, chronic uncontrolled diseases that the investigator considers clinically significant, examination or laboratory findings or reason that the Investigator considers makes the patient unsuitable to participate at Screening.","40 Years",{"count":50,"type":21},56,[24],"This is a randomized, double-blind, placebo-controlled, two-period cross-over study of nebulized ensifentrine (3 mg) or placebo administered BID for two 8-week Treatment Periods. All participants with receive both ensifentrine and placebo during participation. There are 7 in-clinic visits over a total duration of up to 24 weeks participation.",[54],"COPD","2026-05-08",{"date":57,"type":32},"2026-05-13",{"date":59,"type":32},"2022-05-27",{"date":61,"type":21},"2027-06",{"name":38,"class":39},3,""]