A Phase II, Randomized, Double-Blind, Placebo- Controlled Study of Ensifentrine in Subjects With Non-Cystic Fibrosis Bronchiectasis
Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA
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).
Description
The primary objective of this study is to assess the effect of ensifentrine vs placebo in addition to standard of care on pulmonary exacerbations, symptoms and quality of life in participants with NCFBE. The Treatment Period for each subject will begin with the first dose of study medication and will continue for at least 24 weeks and up to 52 weeks. Subjects will end their Treatment Period at the Week 52 visit or when all active subjects in the study have completed through at least the Week 24 visit, whichever occurs first. Participants will be randomized to receive either ensifentrine susp…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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: 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 * C…
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 HospitalBirmingham, Alabama
- So Cal Institute for Respiratory Diseases, Inc.Los Angeles, California
- University of California Davis Medical CenterSacramento, California
- National Jewish Health Main CampusDenver, Colorado
- MedStar Georgetown University HospitalWashington D.C., District of Columbia
- University of MiamiMiami, Florida