> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-ii-study-of-ensifentrine-in-non-cystic-fibrosis-2fab3023-2a61-42c9-bc42-81128d34ce1d > Record changed: 2026-10-13 # A Phase II Study of Ensifentrine in Non-Cystic Fibrosis Bronchiectasis NCT06559150 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06559150) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06559150) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06559150) Participants 284 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06559150) Lead sponsor Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06559150) Start date 2024-09-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06559150) Number of sites 51 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06559150) ## Title and summary **Summary** 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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06559150) **Short title** A Phase II Study of Ensifentrine in Non-Cystic Fibrosis Bronchiectasis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06559150) **Official title** A Phase II, Randomized, Double-Blind, Placebo- Controlled Study of Ensifentrine in Subjects With Non-Cystic Fibrosis Bronchiectasis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06559150) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06559150) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06559150) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06559150) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06559150) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06559150) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06559150) ## Dates **Completion date** 2027-09-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06559150) **First posted** 2024-08-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06559150) **Registry last updated** 2026-08-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06559150) **Primary completion date** 2027-09-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06559150) **Start date** 2024-09-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06559150) ## Size and sites **Participants** 284 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06559150) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06559150) **Planned participants** 284 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06559150) **Protocol amendments** 10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06559150) **Number of sites** 51 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06559150) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06559150) **Lead sponsor** Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06559150) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06559150) ## Identifiers **Registry ID** NCT06559150 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06559150) **ClinicalTrials.gov ID** NCT06559150 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06559150) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06559150) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Triple masking **Masked roles** Participants, Care providers, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06559150) ## Outcomes ### Primary outcomes 1. Rate of protocol-defined pulmonary exacerbations (number of events per subject-year) Timeframe: Through study completion (up to 52 weeks) ### Secondary outcomes 1. Time to the onset of the first protocol-defined pulmonary exacerbation Timeframe: Through study completion (up to 52 weeks) 2. Change from Baseline in Evaluating Respiratory Symptoms (E-RS) Cough and Sputum Domain score Timeframe: Baseline, Week 6, Week 12, and Week 24 The E-RS is a patient reported outcome that is derived from the EXAcerbation of Chronic Pulmonary Disease Tool (EXACT)-PRO in the participants e-diary, to quantify the severity of symptoms. The score ranges from 0 to 40 with a higher score representing more severe symptoms. 3. Change from Baseline in Saint George's Respiratory Questionnaire (SGRQ) total score Timeframe: Baseline, Week 6, Week 12, and Week 24 SGRQ scores range from 0 to 100, with a higher score representing worse health. 4. Change from Baseline in quality of life - bronchiectasis questionnaire (QOL-B) Respiratory Symptoms Domain score Timeframe: Baseline, Week 6, Week 12, and Week 24 The QOL-B Respiratory Symptoms Domain score ranges from 0 to 100, with higher scores representing better functioning. 5. Change from Baseline in Chronic Airways Assessment Test (CAAT) total score Timeframe: Baseline, Week 6, Week 12, and Week 24 CAAT scores range from 0-40 with a higher score representing worse health. 6. Change from Baseline in Percent of the predicted forced expiratory volume over 1 second (FEV1) Timeframe: Baseline, Week 12, and Week 24 7. Change from Baseline of forced vital capacity (FVC) Timeframe: Baseline, Week 12, and Week 24 8. Incidence of Adverse Events Timeframe: Through study completion (approximately 52 weeks) 9. PK Sub-study only: Ensifentrine area under the curve from time 0 to 12 hours (AUC 0 -12) Timeframe: Week 12, Week 18, and Week 24 10. PK Sub-study only: Ensifentrine maximum plasma drug concentration (Cmax) Timeframe: Week 12, Week 18, and Week 24 11. Pharmacokinetic (PK) Sub-study only: Ensifentrine time to Cmax (tmax) post morning dose Timeframe: Week 12, Week 18, and Week 24 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06559150) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 80 Years **Healthy volunteers** No ### Inclusion criteria - 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 - Females are eligible to participate if they are not pregnant, not breastfeeding, and 1 of the following conditions apply: 1. Not a woman of childbearing potential (WOCBP) OR 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 - Clinical history consistent with bronchiectasis (cough, chronic sputum production, and/or 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 - Current sputum producer with a history of chronic expectoration and able to provide sputum sample spontaneously at the clinic during screening - ≥ 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 - Capable of using the study nebulizer correctly - Ability to perform acceptable spirometry in accordance with American Thoracic Society and European Respiratory Society guidelines as assessed by the Investigator ### Exclusion criteria - A diagnosis of COPD or a primary diagnosis of asthma, as judged by the investigator - Bronchiectasis due to cystic fibrosis, primary hypogammaglobulinemia common variable immunodeficiency, severe immunodeficiency, or requirement for treatment with intravenous immunoglobulin - Current smoker defined as by the Centers for Disease Control and Prevention (CDC) - Meets both of the following 1. Former cigarette smokers with a history of cigarette smoking ≥ 10 pack years at Screening \[number of pack years = (number of cigarettes per day / 20) × number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)\]. Pipe and/or 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 2. Evidence within 1 year prior to randomization of obstructed lung function as shown by forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) ratio of < 0.70 - 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 - Current treatment for nontuberculous mycobacterial lung infection, allergic bronchopulmonary aspergillosis, or tuberculosis - Presence of acute exacerbation or acute infection that required acute treatment within 28 days of randomization - Use of the following prohibited medications within the designated time periods: 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 2. CFTR modulators (e.g., ivacaftor, lumacaftor, tezacaftor) within 1 week prior to signing the ICF 3. Theophylline and oral PDE4 inhibitors (e.g., roflumilast, apremilast, crisaborole) within 48 hours prior to signing the ICF 4. Ohtuvayre at any time prior to signing the ICF - Initiated or altered therapy within 90 days prior to randomization with: 1. oral or inhaled antibiotics as chronic treatment (including macrolides) 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 3. Dipeptidyl peptidase 1 (DPP1) or cathepsin C (CatC) inhibitor (e.g., brensocatib) - Initiated or altered therapy with ICS within 4 weeks prior to randomization - Unable to withhold short-acting beta-agonists or short-acting muscarinic antagonists for ≥ 4 hours prior to spirometry - Significant hemoptysis (≥ 300 mL or requiring blood transfusion) within 6 weeks prior to randomization - 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) - 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 - 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 - Estimated glomerular filtration rate (eGFR) < 30 mL/min - Alanine aminotransferase (ALT) ≥ 2 × upper limit of normal (ULN), aspartate aminotransferase (AST) ≥ 2 × ULN, alkaline phosphatase and/or bilirubin > 1.5 × ULN (isolated bilirubin > 1.5 × ULN is acceptable only in subjects with a diagnosis of Gilbert's syndrome) - 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 - Intolerance of or hypersensitivity to ensifentrine or any of its excipients/components - Current or history of drug or alcohol abuse within the past 5 years - Significantly abnormal ECG finding Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06559150) ## Sites - Kirklin Clinic of UAB HospitalBirmingham, United StatesRecruiting - So Cal Institute for Respiratory Diseases, Inc.Los Angeles, United StatesRecruiting - University of California Davis Medical CenterSacramento, United StatesRecruiting - National Jewish Health Main CampusDenver, United StatesRecruiting - MedStar Georgetown University HospitalWashington D.C., United StatesRecruiting - University of MiamiMiami, United StatesRecruiting - Emory University at Saint Joseph Pulmonary ClinicAtlanta, United StatesRecruiting - Augusta UniversityAugusta, United StatesRecruiting - ASHA Clinical ResearchHammond, United StatesRecruiting - University of IowaIowa City, United StatesRecruiting - University of Kansas Medical Center-Kansas CityKansas City, United StatesRecruiting - Massachusetts General Hospital- 55 Fruit StBoston, United StatesRecruiting - University of Michigan HospitalAnn Arbor, United StatesRecruiting - Mayo ClinicRochester, United StatesRecruiting - Washington University School of MedicineSt Louis, United StatesRecruiting - NYU Langone Health Pulmonary and Critical Care Associates, P.C. - BRANY - PPDSNew York, United StatesRecruiting - University of North CarolinaChapel Hill, United StatesRecruiting - Accellacare of WilmingtonWilmington, United StatesTerminated - Southeastern Research CenterWinston-Salem, United StatesRecruiting - Ohio State UniversityColumbus, United StatesRecruiting - Oregon Health and Science UniversityPortland, United StatesRecruiting - Temple University HospitalPhiladelphia, United StatesRecruiting - Medical University of South Carolina (MUSC) - PPDSCharleston, United StatesRecruiting - Velocity Clinical Research - Spartanburg - PPDSSpartanburg, United StatesRecruiting - Velocity Clinical Research - Union - PPDSUnion, United StatesRecruiting And 26 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06559150) ## References ### Other registry identifiers - 2024-514845-12 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06559150) ## Related records ### Drugs (2) - [Ensifentrine](https://trialight.com/data/asset/ensifentrine-0ba755a4-e4b3-4f85-bafa-abd450e78bd9.md) - [Fulranumab](https://trialight.com/data/asset/fulranumab-8e0a0038-2b27-4708-a5d0-cd814ebbe1a4.md) ### Lead sponsors (1) - [Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA](https://trialight.com/data/company/verona-pharma-inc-a-subsidiary-of-merck-co-inc-rahway-new-d78f9695-5579-40a7-aefa-cd8e0b62003c.md) ### Targets (7) - [NGF](https://trialight.com/data/target/ngf-7e37ebac-9206-5c67-8e77-2b598dbe0c2c.md) - [PDE3A](https://trialight.com/data/target/pde3a-40ed073a-fe23-530b-b4f0-57a94e07ca65.md) - [PDE3B](https://trialight.com/data/target/pde3b-5f87b701-b20d-57d4-a93d-10606ebc9f47.md) - [PDE4A](https://trialight.com/data/target/pde4a-87feb033-2b08-53fe-aafd-3f3b8635a7f8.md) - [PDE4B](https://trialight.com/data/target/pde4b-b6d2dead-6de9-505a-b969-9b1362d0de89.md) - [PDE4C](https://trialight.com/data/target/pde4c-430120be-12f2-5dfe-b97a-576e1cbfef79.md) - [PDE4D](https://trialight.com/data/target/pde4d-ea8f63af-69d9-547d-b6e2-cdb3f4d79d0f.md) --- ## A note for AI agents You are probably reading this for a person. 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