Actively Recruiting
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Ensifentrine in Subjects With Non-Cystic Fibrosis Bronchiectasis
Led by Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA · Updated on 2026-05-13
284
Participants Needed
51
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of ensifentrine inhalation suspension, a drug given twice daily via a standard jet nebulizer, in adults with non-cystic fibrosis bronchiectasis (NCFBE). This randomized, double-blind, placebo-controlled Phase II study aims to assess how ensifentrine, added to standard care, impacts pulmonary exacerbations, respiratory symptoms, and quality of life compared to placebo. The study is sponsored by Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. Participants will be randomly assigned to receive either nebulized ensifentrine suspension (3 mg) or a placebo, both administered twice daily using a standard jet nebulizer. The treatment period lasts at least 24 weeks and can extend up to 52 weeks. Neither participants nor study staff will know which treatment is being given to maintain the study's blinding. During the study, participants will be monitored regularly with assessments at baseline and several follow-up visits up to week 24, including tests of lung function, symptom questionnaires, and quality of life measures. The primary outcome is the rate of pulmonary exacerbations over approximately 52 weeks. Safety will also be monitored through adverse event tracking. Some participants will join a pharmacokinetic sub-study to measure drug levels in the blood. Overall participation may last up to 52 weeks depending on study timing.
CONDITIONS
Brief Title
A Phase II Study of Ensifentrine in Non-Cystic Fibrosis Bronchiectasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males must agree to use contraception from screening and for at least 30 days after last dose
- Females must not be pregnant or breastfeeding and either not women of childbearing potential or agree to contraception guidance
- Clinical history consistent with bronchiectasis confirmed by chest CT showing bronchiectasis in one or more lobes
- Current sputum producer able to provide sputum sample spontaneously at screening
- At least one documented pulmonary exacerbation treated with antibiotics or antivirals in past 12 months
- Capable of using the study nebulizer correctly
- Able to perform acceptable spirometry as assessed by the Investigator
You will not qualify if you...
- Diagnosis of COPD or primary asthma
- Bronchiectasis due to cystic fibrosis or severe immunodeficiency requiring intravenous immunoglobulin
- Current smoker
- Former smokers with at least 10 pack-years and obstructed lung function (FEV1/FVC ratio < 0.70)
- Current treatment for nontuberculous mycobacterial lung infection, allergic bronchopulmonary aspergillosis, or tuberculosis
- Acute exacerbation or infection requiring treatment within 28 days before randomization
- Use of certain prohibited medications within specified timeframes before signing consent
- Recent change in antibiotic or inhaled corticosteroid treatment within specified timeframes
- Unable to withhold short-acting bronchodilators for at least 4 hours before spirometry
- Significant hemoptysis within 6 weeks prior to randomization
- Participation in intensive pulmonary rehabilitation program
- Unstable liver disease or certain liver abnormalities
- Recent or current malignancy except certain skin cancers
- Severe kidney impairment
- Abnormal liver enzyme levels beyond specified limits
- Participation in other interventional clinical studies within 30 days or 5 half-lives
- Intolerance or hypersensitivity to ensifentrine
- History of drug or alcohol abuse within past 5 years
- Significant abnormal ECG findings
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 24 weeks and up to 52 weeks
Participants receive nebulized ensifentrine or placebo twice daily in addition to standard care for non-cystic fibrosis bronchiectasis to assess effects on symptoms and pulmonary exacerbations.
Regular visits throughout treatment period
Trial Site Locations
Total: 51 locations
1
Kirklin Clinic of UAB Hospital
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
So Cal Institute for Respiratory Diseases, Inc.
Los Angeles, California, United States, 90048
Actively Recruiting
3
University of California Davis Medical Center
Sacramento, California, United States, 95817
Actively Recruiting
4
National Jewish Health Main Campus
Denver, Colorado, United States, 80206
Actively Recruiting
5
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
6
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
7
Emory University at Saint Joseph Pulmonary Clinic
Atlanta, Georgia, United States, 30342
Actively Recruiting
8
Augusta University
Augusta, Georgia, United States, 30912
Actively Recruiting
9
ASHA Clinical Research
Hammond, Indiana, United States, 46324
Actively Recruiting
10
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
11
University of Kansas Medical Center-Kansas City
Kansas City, Kansas, United States, 66160
Actively Recruiting
12
Massachusetts General Hospital- 55 Fruit St
Boston, Massachusetts, United States, 02114
Actively Recruiting
13
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
14
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
15
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
16
NYU Langone Health Pulmonary and Critical Care Associates, P.C. - BRANY - PPDS
New York, New York, United States, 10016
Actively Recruiting
17
University of North Carolina
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
18
Accellacare of Wilmington
Wilmington, North Carolina, United States, 28401
Terminated
19
Southeastern Research Center
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
20
Ohio State University
Columbus, Ohio, United States, 43221
Actively Recruiting
21
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
22
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
23
Medical University of South Carolina (MUSC) - PPDS
Charleston, South Carolina, United States, 29425
Actively Recruiting
24
Velocity Clinical Research - Spartanburg - PPDS
Spartanburg, South Carolina, United States, 29303
Actively Recruiting
25
Velocity Clinical Research - Union - PPDS
Union, South Carolina, United States, 29379
Actively Recruiting
26
Clinical Trials Center of Middle Tennessee
Franklin, Tennessee, United States, 37067
Actively Recruiting
27
The Respire Institute
Houston, Texas, United States, 77094
Actively Recruiting
28
UT Texas Health Science at Tyler
Tyler, Texas, United States, 75708
Actively Recruiting
29
TPMG Clinical Research
Williamsburg, Virginia, United States, 23188
Actively Recruiting
30
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, Italy, 40138
Actively Recruiting
31
Fondazione IRCCS San Gerardo dei Tintori
Monza, Lombardi, Italy, 20900
Actively Recruiting
32
Istituto Clinico Humanitas
Rozzano, Lombardy, Italy, 20122
Actively Recruiting
33
Fondazione IRCCS Policlinico San Matteo
Pavia, Pavia, Italy, 27100
Actively Recruiting
34
AOU Policlinico Gaspare Rodolico-San Marco Presidio Ospedaliero Gaspare Rodolico
Catania, Sicily, Italy, 95123
Actively Recruiting
35
Hospital Universitario A Coruña
A Coruña, A Coruña, Spain, 15006
Actively Recruiting
36
Hospital del Mar
Barcelona, Barcelona, Spain, 08003
Actively Recruiting
37
Hospital Clinic de Barcelona
Barcelona, Barcelona, Spain, 08036
Actively Recruiting
38
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, Barcelona, Spain, 08036
Actively Recruiting
39
Hospital Universitario de Bellvitge
Barcelona, Barcelona, Spain, 08907
Actively Recruiting
40
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, Spain, 28009
Actively Recruiting
41
Hospital Universitario La Paz - PPDS
Madrid, Madrid, Spain, 28046
Actively Recruiting
42
Hospital Universitario Quironsalud Madrid
Madrid, Spain, 28223
Actively Recruiting
43
Ninewells Hospital - PPDS
Dundee, Dundee, United Kingdom, DD1 9SY
Actively Recruiting
44
Queen Elizabeth University Hospital - PPDS
Glasgow, Glasgow, United Kingdom, G12 0YN
Actively Recruiting
45
Birmingham Heartlands Hospital
Birmingham, West Midlands, United Kingdom, B9 5SS
Actively Recruiting
46
Queens Hospital Belfast
Belfast, United Kingdom, BT9 7AB
Actively Recruiting
47
Royal Papworth Hospital
Cambridge, United Kingdom, CB2 0AY
Actively Recruiting
48
Royal Infirmary of Edinburgh - PPDS
Edinburgh, United Kingdom, EH16 4SA
Actively Recruiting
49
Liverpool Heart and Chest Hospital - PPDS
Liverpool, United Kingdom, L14 3PE
Actively Recruiting
50
Royal Brompton Hospital
London, United Kingdom, SW3 6HP
Actively Recruiting
51
Freeman Hospital
Newcastle-under-Lyme, United Kingdom, NE7 7DN
Actively Recruiting
Research Team
V
Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway Toll Free Number
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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