Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
Study NCT ID:
NCT07016412
Status:
RECRUITING
Last Update Posted:
2025-10-14
First Post:
2025-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase IIb Ensifentrine-glycopyrrolate Fixed-dose Combination Dose Ranging Study in Subjects With COPD
Sponsor:
Verona Pharma plc
Organization:
Study Overview
Official Title:
A Phase IIb, Randomized, Double-blind, Placebo- Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ensifentrine-glycopyrrolate Fixed-dose Combination at Two Dose Levels Compared to Glycopyrrolate or Ensifentrine Monotherapy in Subjects With COPD
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will assess the safety and efficacy of fixed dose combinations of ensifentrine with two different glycopyrrolate dose levels compared to placebo and to the individual components of the fixed dose combinations, each administered twice a day via standard jet nebulizer, in adult subjects with chronic obstructive pulmonary disease (COPD).
Detailed Description:
Enrolled participants will be expected to participate for approximately 7 weeks: 1 to 2 weeks for screening, 4 weeks of treatment, and 1 week of follow up. Participants will be randomized to one of 6 treatment arms: two fixed dose combinations of ensifentrine (3 mg) and glycopyrrolate (either 21.25 or 42.5 mcg), the 3 individual components as monotherapies, or placebo. All treatments will be administered twice a day via oral inhalation by a standard jet nebulizer. The primary objective of this study is to evaluate the bronchodilator effects of the fixed dose combinations compared to each of the individual components and to placebo.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: