RecruitingPhase 2NCT06559150

A Phase II Study of Ensifentrine in Non-Cystic Fibrosis Bronchiectasis

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

Sponsor

Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA

Enrollment

284 participants

Start Date

Sep 11, 2024

Study Type

INTERVENTIONAL

Conditions

Non-cystic Fibrosis Bronchiectasis

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Nebulized Ensifentrine Suspension; 3 mg and a drug called Nebulized Placebo Solution for people with non-cystic fibrosis bronchiectasis. The study is currently recruiting participants at 51 locations. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNebulized Ensifentrine Suspension; 3 mg

Administered by a standard jet nebulizer, twice daily for a minimum of 24 weeks and up to a maximum of 52 weeks

DRUGNebulized Placebo Solution

Administered by a standard jet nebulizer, twice daily for a minimum of 24 weeks and up to a maximum of 52 weeks

Locations(51)

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

Ohio State University

Columbus, Ohio, 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

View Full Details on ClinicalTrials.gov

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NCT06559150

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