Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06559150
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
A Phase II Study of Ensifentrine in Non-Cystic Fibrosis Bronchiectasis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase II Randomized Double-Blind Placebo- Controlled Study of Ensifentrine in Subjects with Non-Cystic Fibrosis Bronchiectasis
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 study is designed as a pulmonary exacerbation event-driven study where participants will be treated for 24 weeks and until 120 subjects have experienced at least 1 protocol-defined pulmonary exacerbation 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 receiving
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None