A Phase II, Randomized, Double-Blind, Placebo- Controlled Study of Ensifentrine in Subjects With Non-Cystic Fibrosis Bronchiectasis

Status: Recruiting
Location: See all (47) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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 over at least 24 weeks, compared to placebo, in subjects with non-cystic fibrosis bronchiectasis (NCFBE).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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:

‣ Not a woman of childbearing potential (WOCBP) OR

⁃ 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

Locations
United States
Alabama
Kirklin Clinic of UAB Hospital
RECRUITING
Birmingham
California
So Cal Institute for Respiratory Diseases, Inc.
RECRUITING
Los Angeles
University of California Davis Medical Center
RECRUITING
Sacramento
Colorado
National Jewish Health Main Campus
RECRUITING
Denver
Washington, D.c.
MedStar Georgetown University Hospital
RECRUITING
Washington D.c.
Florida
University of Miami
RECRUITING
Miami
Georgia
Emory University at Saint Joseph Pulmonary Clinic
RECRUITING
Atlanta
Augusta University
RECRUITING
Augusta
Iowa
University of Iowa
RECRUITING
Iowa City
Indiana
ASHA Clinical Research
RECRUITING
Hammond
Kansas
University of Kansas Medical Center-Kansas City
RECRUITING
Kansas City
Massachusetts
Massachusetts General Hospital- 55 Fruit St
RECRUITING
Boston
Michigan
University of Michigan Hospital
RECRUITING
Ann Arbor
Minnesota
Mayo Clinic
RECRUITING
Rochester
Missouri
Washington University School of Medicine
RECRUITING
St Louis
North Carolina
University of North Carolina
RECRUITING
Chapel Hill
Accellacare of Wilmington
RECRUITING
Wilmington
Southeastern Research Center
RECRUITING
Winston-salem
New York
NYU Langone Health Pulmonary and Critical Care Associates, P.C. - BRANY - PPDS
RECRUITING
New York
Oregon
Oregon Health and Science University
RECRUITING
Portland
Pennsylvania
Temple University Hospital
RECRUITING
Philadelphia
South Carolina
Medical University of South Carolina (MUSC) - PPDS
RECRUITING
Charleston
Tennessee
Clinical Trials Center of Middle Tennessee
RECRUITING
Franklin
Texas
UT Texas Health Science at Tyler
RECRUITING
Tyler
Virginia
TPMG Clinical Research
RECRUITING
Williamsburg
Other Locations
Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna
RECRUITING
Bologna
AOU Policlinico Gaspare Rodolico-San Marco Presidio Ospedaliero Gaspare Rodolico
RECRUITING
Catania
Fondazione IRCCS San Gerardo dei Tintori
RECRUITING
Monza
Fondazione IRCCS Policlinico San Matteo
RECRUITING
Pavia
Istituto Clinico Humanitas
RECRUITING
Rozzano
Spain
Hospital Universitario A Coruña
RECRUITING
A Coruña
Hospital Clinic de Barcelona
RECRUITING
Barcelona
Hospital del Mar
RECRUITING
Barcelona
Hospital Universitario de Bellvitge
RECRUITING
Barcelona
Hospital Universitario Vall d'Hebron - PPDS
RECRUITING
Barcelona
Hospital General Universitario Gregorio Marañon
RECRUITING
Madrid
Hospital Universitario La Paz - PPDS
RECRUITING
Madrid
Hospital Universitario Quironsalud Madrid
RECRUITING
Madrid
United Kingdom
Queens Hospital Belfast
RECRUITING
Belfast
Birmingham Heartlands Hospital
RECRUITING
Birmingham
Royal Papworth Hospital
RECRUITING
Cambridge
Ninewells Hospital - PPDS
RECRUITING
Dundee
Royal Infirmary of Edinburgh - PPDS
RECRUITING
Edinburgh
Queen Elizabeth University Hospital - PPDS
RECRUITING
Glasgow
Liverpool Heart and Chest Hospital - PPDS
RECRUITING
Liverpool
Royal Brompton Hospital
RECRUITING
London
Freeman Hospital
RECRUITING
Newcastle-under-lyme
Contact Information
Primary
Verona Pharma Clinical Trials
clinicaltrials@veronapharma.com
Please reach out by email
Time Frame
Start Date: 2024-09-11
Estimated Completion Date: 2026-09
Participants
Target number of participants: 180
Treatments
Experimental: Treatment Arm 1: Ensifentrine
Placebo_comparator: Treatment Arm 2: Placebo
Related Therapeutic Areas
Sponsors
Leads: Verona Pharma plc

This content was sourced from clinicaltrials.gov

Similar Clinical Trials