Actively Recruiting
A Phase II Study of Ensifentrine in 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
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Phase II Study of Ensifentrine in Non-Cystic Fibrosis Bronchiectasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male participants must agree to use contraception during the study and for 30 days after the last dose
- Female participants must not be pregnant or breastfeeding and either not be of childbearing potential or agree to contraception during the study and for 30 days after the last dose
- Clinical history consistent with bronchiectasis confirmed by chest CT scan within 5 years or at screening
- Current sputum producer able to provide sputum sample spontaneously at screening
- At least one documented pulmonary exacerbation treated with antimicrobials in the past 12 months
- Ability to use the study nebulizer correctly
- Ability to perform acceptable spirometry according to guidelines as assessed by the investigator
You will not qualify if you...
- Diagnosis of COPD or primary asthma
- Bronchiectasis due to cystic fibrosis, immunodeficiency, or requiring intravenous immunoglobulin treatment
- Current smoker
- Former smokers with 10 or more pack-years and evidence of obstructed lung function
- Current treatment for certain lung infections including nontuberculous mycobacterial infection, allergic bronchopulmonary aspergillosis, or tuberculosis
- Acute exacerbation or infection requiring treatment within 28 days prior to randomization
- Use of chronic systemic immunomodulatory agents within 90 days prior to consent
- Use of CFTR modulators within 1 week prior to consent
- Use of theophylline and oral PDE4 inhibitors within 48 hours prior to consent
- Use of Ohtuvayre at any time prior to consent
- Recent initiation or change of certain antibiotic or inhaled corticosteroid therapies before randomization
- Inability 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 programs
- Unstable liver disease or significant liver abnormalities
- History or current malignancy within past 5 years except certain skin cancers
- Severe kidney impairment (eGFR < 30 mL/min)
- Elevated liver enzymes beyond specified limits
- Participation in other interventional clinical studies within 30 days or 5 half-lives prior to consent
- Hypersensitivity to ensifentrine or its components
- History of drug or alcohol abuse within past 5 years
- Significant abnormal ECG findings
AI-Screening
AI-Powered Screening
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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
CONTACT
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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