[{"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:":86},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,68],{"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":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100594205","phase-2-a-phase-iib-ensifentrine-glycopyrrolate-fixed-dose-combination-dose-ranging-study-in-subjects-with-copd-100594205",false,"NCT07016412","A Phase IIb Ensifentrine-glycopyrrolate Fixed-dose Combination Dose Ranging Study in Subjects With COPD","A Phase IIb, Randomized, Double-blind, Placebo- Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ensifentrine-glycopyrrolate Fixed-dose Combination at Two Dose Levels Compared to Glycopyrrolate or Ensifentrine Monotherapy in Subjects With COPD","Inclusion Criteria:\n\n* Males are eligible to participate if they agree to use contraception or abstinence, and refrain from donating fresh unwashed semen during the study and for at least 30 days post-study\n* Females are eligible to participate if they are not pregnant, breastfeeding and if one of the following conditions apply:\n\n  1. Not a woman of child-bearing potential OR\n  2. Agrees to follow the contraceptive guidance from screening throughout the study and for at least 30 days post-study\n  3. Agrees not to donate eggs for the purpose of reproduction from screening throughout the study and for at least 30 days post-study\n* Current of former cigarette smokers with a history of smoking ≥ 10 pack years at the time of signing informed consent \\[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 signing informed consent. Smoking cessation programs are permitted during the study\n* Subjects with 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* A score of ≥ 2 on the Modified Medical Research Council (mMRC) Dyspnea Scale at the Screening Visit\n* Post-bronchodilator (4 puffs of albuterol) spirometry during the Screening Period demonstrating both the following:\n\n  1. FEV1\u002Fforced vital capacity (FVC) ratio of \\\u003C 0.70 AND\n  2. FEV1 ≥ 30 % and ≤ 70% of predicted normal\n* A posterior-anterior chest x-ray (CXR) during the Screening Period or within 12 months of signing the Informed Consent Form (ICF) showing no clinically significant abnormalities unrelated to COPD. If a CXR within the past 12 months is not available but a computed tomography (CT) scan within the same time period is available, the CT scan may be reviewed in place of a CXR\n* Subjects on no maintenance\u002Fbackground therapy or subjects on stable maintenance as either long-acting β2-agonist (LABA) or long-acting β2-agonist\u002FInhaled corticosteroid (LABA\u002FICS) therapy are eligible. Subjects taking maintenance therapy must demonstrate regular use of maintenance therapy, in any form, for at least 60 days prior to signing informed consent and agree to continue use of their current permitted LABA or LABA\u002FICS medication for the duration of the screening and treatment period\n* Capable of withholding from short-acting bronchodilators for 4 hours prior to spirometry testing. Subjects receiving maintenance therapy with a LABA or LABA\u002FICS must be capable of withholding twice-daily maintenance therapy for 24 hours and once-daily maintenance therapy for 48 hours prior to initiation of any spirometry\n* Capable of using the study jet nebulizer correctly\n* Ability to perform acceptable spirometry in accordance with ATS\u002FERS guidelines\n* Willing and able to attend all study visits and adhere to all study assessments and procedures\n\nExclusion Criteria:\n\n* Concomitant clinically significant pulmonary disease other than COPD (i.e., asthma, tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, interstitial lung diseases, sleep apnea (unless controlled with stable continuous positive airway pressure \\[CPAP\\] use), known alpha-1 antitrypsin deficiency, core pulmonale or other non-specific pulmonary disease\n* Within 6 months prior to randomization, a COPD exacerbation requiring hospitalization\n* Within 3 months prior to randomization, use of oral or systemic therapies for COPD exacerbations (for example, oral, intravenous, or intramuscular glucocorticoids, antibiotics, theophylline, and roflumilast)\n* History of life-threatening COPD, including Intensive Care Unit admission and\u002For requiring intubation\n* Severe comorbidities including\n\n  1. unstable cardiac disease (myocardial infarction within 1 year prior to randomization, unstable angina within 6 months prior to randomization, unstable or life-threatening arrhythmia requiring intervention within 3 months prior to randomization, diagnosis of New York Heart Association (NYHA) class III or IV heart disease, or\n  2. any other clinically significant medical conditions including uncontrolled diseases (e.g., endocrine, neurological, hepatic, gastrointestinal, renal, hematological, urological, immunological, psychiatric \\[e.g. untreated significant depression, anxiety or history of suicidality\\], or ophthalmic diseases) that would, in the opinion of the Investigator, preclude the subject from safely completing the required tests or the study, or is likely to result in disease progression that would require withdrawal of the subject\n* History of or clinically significant on-going bladder outflow obstruction or history of catheterization for relief of bladder outflow obstruction within 6 months prior to randomization\n* History of narrow angle glaucoma\n* History of hypersensitivity or intolerance to aerosol medications, albuterol, ensifentrine, or glycopyrrolate or any of its excipients\u002Fcomponents, anticholinergic agents, or sympathomimetic amines\n* History of or current malignancy of any organ system, treated or untreated within the 5 years prior to randomization, except for localized basal or squamous cell carcinoma of the skin\n* Other significant psychiatric disease that would likely result in the subject not being able to complete the study, in the opinion of the Investigator\n* Findings on physical examination that an investigator considers to be clinically significant or abnormal during the Screening Period including hematology, biochemistry, viral serology, and ECG\n* Prior or current use of Ohtuvayre (ensifentrine)\n* Previous lung resection or lung reduction surgery within 1-year of randomization\n* Long term oxygen use defined as oxygen therapy prescribed for greater than 12 hours per day. As needed oxygen use (≤ 12 hours per day) is not exclusionary\n* Pulmonary rehabilitation unless such treatment has been stable from 4 weeks prior to signing the ICF and plans to remain stable during the study. Pulmonary rehabilitation programs should not be started or completed during participation in the study\n* Major surgery (requiring general anesthesia) in the 6 weeks prior randomization, lack of full recovery from surgery at randomization, or planned surgery through the end of the study\n* Current or history of drug or alcohol abuse within the 5 years prior to randomization\n* Estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin as tested during the Screening Period\n* Alanine aminotransferase (ALT) ≥ 2 × upper limit of normal (ULN), aspartate aminotransferase (AST) ≥ 2 × ULN, alkaline phosphatase and\u002For total bilirubin \\> 1.5 × ULN (subjects with Gilbert's syndrome can be included with total bilirubin \\>1.5 × ULN as long as direct bilirubin is ≤ 1.5 × ULN)\n* Use of an experimental drug within 30 days or 5 half-lives of signing the ICF, whichever is longer, and\u002For participation in a study treatment-free follow-up phase of a clinical study within 30 days prior to signing the ICF\n* Use of an experimental medical device or participation in a follow-up phase of an experimental medical device clinical study within 30 days prior to informed consent\n* Affiliation with the investigator site, including an Investigator, Sub-Investigator, study coordinator, study nurse, other employee of participating investigator or study site or a family member of the aforementioned","ALL","40 Years","80 Years",{"count":20,"type":21},480,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study will assess the safety and efficacy of fixed dose combinations of ensifentrine with two different glycopyrrolate dose levels compared to placebo and to the individual components of the fixed dose combinations, each administered twice a day via standard jet nebulizer, in adult subjects with chronic obstructive pulmonary disease (COPD).",[27],"Chronic Obstructive Pulmonary Disease",[27,29,30,31],"COPD","bronchodilator","ensifentrine-glycopyrrolate","RECRUITING","2026-06-01",{"date":35,"type":36},"2026-06-03","ACTUAL",{"date":38,"type":36},"2025-07-31",{"date":40,"type":21},"2026-08-05",{"name":42,"class":43},"Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA","INDUSTRY",57,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":18,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100559055","phase-2-a-phase-ii-study-of-ensifentrine-in-non-cystic-fibrosis-bronchiectasis-100559055","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","18 Years",{"count":54,"type":21},284,[24],"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 over at least 24 weeks, compared to placebo, in subjects with non-cystic fibrosis bronchiectasis (NCFBE).",[58],"Non-cystic Fibrosis Bronchiectasis","2026-05-08",{"date":61,"type":36},"2026-05-13",{"date":63,"type":36},"2024-09-11",{"date":65,"type":21},"2027-09-24",{"name":42,"class":43},51,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":77,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":80,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":5},"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.",{"count":76,"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.",[29],{"date":61,"type":36},{"date":82,"type":36},"2022-05-27",{"date":84,"type":21},"2027-06",{"name":42,"class":43},""]