A Phase II Study of Ensifentrine in Non-Cystic Fibrosis Bronchiectasis
NCT ID: NCT06559150
Last Updated: 2025-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
180 participants
INTERVENTIONAL
2024-09-11
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Treatment Arm 1: Ensifentrine
Nebulized Ensifentrine Suspension; 3 mg
Administered by a standard jet nebulizer, twice daily for a minimum of 24 weeks and up to a maximum of 156 weeks (3 years)
Treatment Arm 2: Placebo
Nebulized Placebo Solution
Administered by a standard jet nebulizer, twice daily for a minimum of 24 weeks and up to a maximum of 156 weeks (3 years)
Interventions
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Nebulized Ensifentrine Suspension; 3 mg
Administered by a standard jet nebulizer, twice daily for a minimum of 24 weeks and up to a maximum of 156 weeks (3 years)
Nebulized Placebo Solution
Administered by a standard jet nebulizer, twice daily for a minimum of 24 weeks and up to a maximum of 156 weeks (3 years)
Eligibility Criteria
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Inclusion Criteria
* 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 antibiotic prescription 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
Exclusion Criteria
* Bronchiectasis due to cystic fibrosis, 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)
* 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
* A diagnosis of primary ciliary dyskinesia
* 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. Immunomodulatory agents for any indication (including but not limited to the following: methotrexate, systemic corticosteroids, see adalimumab, azathioprine, dupilumab, cyclosporine) 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 PDE4 inhibitors (e.g., roflumilast, apremilast, crisaborole) within 48 hours prior to signing the ICF
4. Brensocatib within 3 months or 5 half-lives, whichever is longer, prior to signing the ICF
5. Ohtuvayre at any time prior to signing the ICF
* Initiated or altered therapy within 90 days of randomization with:
1. oral or inhaled antibiotics as chronic treatment
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 and through the day of randomization
* 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 a diagnosis of 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 before Day 1, or 5 half-lives, whichever is longer
* 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
18 Years
85 Years
ALL
No
Sponsors
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Verona Pharma plc
INDUSTRY
Responsible Party
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Locations
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Kirklin Clinic of UAB Hospital
Birmingham, Alabama, United States
So Cal Institute for Respiratory Diseases, Inc.
Los Angeles, California, United States
University of California Davis Medical Center
Sacramento, California, United States
National Jewish Health Main Campus
Denver, Colorado, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
University of Miami
Miami, Florida, United States
Emory University at Saint Joseph Pulmonary Clinic
Atlanta, Georgia, United States
Augusta University
Augusta, Georgia, United States
ASHA Clinical Research
Hammond, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
University of Kansas Medical Center-Kansas City
Kansas City, Kansas, United States
Massachusetts General Hospital- 55 Fruit St
Boston, Massachusetts, United States
University of Michigan Hospital
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
NYU Langone Health Pulmonary and Critical Care Associates, P.C. - BRANY - PPDS
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Accellacare of Wilmington
Wilmington, North Carolina, United States
Southeastern Research Center
Winston-Salem, North Carolina, United States
Oregon Health and Science University
Portland, Oregon, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Medical University of South Carolina (MUSC) - PPDS
Charleston, South Carolina, United States
Velocity Clinical Research - Spartanburg - PPDS
Spartanburg, South Carolina, United States
Velocity Clinical Research - Union - PPDS
Union, South Carolina, United States
Clinical Trials Center of Middle Tennessee
Franklin, Tennessee, United States
The Respire Institute
Houston, Texas, United States
UT Texas Health Science at Tyler
Tyler, Texas, United States
TPMG Clinical Research
Williamsburg, Virginia, United States
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza, Lombardi, Italy
Istituto Clinico Humanitas
Rozzano, Lombardy, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, Pavia, Italy
AOU Policlinico Gaspare Rodolico-San Marco Presidio Ospedaliero Gaspare Rodolico
Catania, Sicily, Italy
Hospital Universitario A Coruña
A Coruña, A Coruña, Spain
Hospital del Mar
Barcelona, Barcelona, Spain
Hospital Clinic de Barcelona
Barcelona, Barcelona, Spain
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, Barcelona, Spain
Hospital Universitario de Bellvitge
Barcelona, Barcelona, Spain
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, Spain
Hospital Universitario La Paz - PPDS
Madrid, Madrid, Spain
Hospital Universitario Quironsalud Madrid
Madrid, , Spain
Ninewells Hospital - PPDS
Dundee, Dundee, United Kingdom
Queen Elizabeth University Hospital - PPDS
Glasgow, Glasgow, United Kingdom
Birmingham Heartlands Hospital
Birmingham, West Midlands, United Kingdom
Queens Hospital Belfast
Belfast, , United Kingdom
Royal Papworth Hospital
Cambridge, , United Kingdom
Royal Infirmary of Edinburgh - PPDS
Edinburgh, , United Kingdom
Liverpool Heart and Chest Hospital - PPDS
Liverpool, , United Kingdom
Royal Brompton Hospital
London, , United Kingdom
Freeman Hospital
Newcastle-under-Lyme, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2024-514845-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
RPL554-NCFB-220
Identifier Type: -
Identifier Source: org_study_id
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