Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA
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 up to 52 weeks, compared to placebo, in participants with non-cystic fibrosis bronchiectasis (NCFBE).
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. Participants will be treated for up to 52 weeks (some subjects may end earlier as the sponsor may end the study after the last subject in the study completes the Week 24 visit). Participants will be randomized to receive either ensifentrine suspension or placebo via standard jet nebulizer during the treatment period and neither participants nor study staff will know which a participant is re…
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…
Administered by a standard jet nebulizer, twice daily up to a maximum of 52 weeks
Administered by a standard jet nebulizer, twice daily up to a maximum of 52 weeks