[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100460046":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":93,"collaborators":95,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":25,"eligibilityCriteria":104,"healthyVolunteers":100,"sex":105,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":25,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":25,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Sequence 1","EXPERIMENTAL","Treatment Period 1 (blinded Ensifentrine) followed by Treatment Period 2 (blinded Placebo)",[13,14],"Drug: Ensifentrine","Drug: Placebo",{"label":16,"type":10,"description":17,"interventionNames":18},"Treatment Sequence 2","Treatment Period 1 (blinded Placebo) followed by Treatment Period 2 (blinded Ensifentrine)",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Ensifentrine","Ensifentrine twice daily administered with jet nebulizer for 8 weeks",[9,16],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Placebo","Placebo ensifentrine twice daily administered with jet nebulizer for 8 weeks",[9,16],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Toll Free Number","CONTACT","1-888-577-8839","Trialsites@msd.com",[37,59,76],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"University of Alabama at Birmingham","RECRUITING","Birmingham","Alabama","35205","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-86.80249,33.52066,{"lat":49,"lon":48},[52,56],{"name":53,"role":33,"phone":54,"phoneExt":25,"email":55},"Bennett Suttles","205-934-5555","LungHealth@uabmc.edu",{"name":57,"role":58,"phone":25,"phoneExt":25,"email":25},"James M Wells, MD","PRINCIPAL_INVESTIGATOR",{"facility":60,"status":39,"city":61,"state":62,"zip":63,"country":43,"countryCode":44,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"University of Michigan","Ann Arbor","Michigan","48109",{"type":46,"coordinates":65},[66,67],-83.74088,42.27756,{"lat":67,"lon":66},[70,74],{"name":71,"role":33,"phone":72,"phoneExt":25,"email":73},"G. Bautista","734.764.8146","umhealthresearch@umich.edu",{"name":75,"role":58,"phone":25,"phoneExt":25,"email":25},"Wassim Labaki, MD",{"facility":77,"status":39,"city":78,"state":79,"zip":80,"country":43,"countryCode":44,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"University of Pittsburgh Medical Center","Pittsburgh","Pennsylvania","15213",{"type":46,"coordinates":82},[83,84],-79.99589,40.44062,{"lat":84,"lon":83},[87,91],{"name":88,"role":33,"phone":89,"phoneExt":25,"email":90},"Paula Consolaro","412-648-6404","consolaropj@upmc.edu",{"name":92,"role":58,"phone":25,"phoneExt":25,"email":25},"Frank C Sciurba, MD",{"type":94,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[96],{"name":38,"class":97},"OTHER","100460046","phase-2-effect-of-ensifentrine-on-sputum-markers-of-inflammation-in-copd-100460046",false,"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.","ALL","40 Years","80 Years",{"count":109,"type":110},56,"ESTIMATED","INTERVENTIONAL",[113],"PHASE2","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.",[116],"COPD","2026-05-08",{"date":119,"type":120},"2026-05-13","ACTUAL",{"date":122,"type":120},"2022-05-27",{"date":124,"type":110},"2027-06",{"name":5,"class":6},3]