Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06545500
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
A Phase IIb Study of Glycopyrrolate Inhalation Solution Over 1 Week in Subjects With COPD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase IIb Randomized Double-blind Placebo-controlled Study to Assess the Efficacy Safety and Pharmacokinetics of Glycopyrrolate Inhalation Solution Over 1 Week in Subjects With COPD
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 complete block cross-over study designed to assess the efficacy safety and pharmacokinetics of 3 dose levels of glycopyrrolate inhalation solution delivered twice daily via standard jet nebulizer over three 1-week active treatment periods and one 1-week placebo period in subjects with chronic obstructive pulmonary disease COPD
Detailed Description:
Participants enrolled will be expected to participate for approximately 10 weeks1-2 weeks for screening four 1-week treatment periods separated by 1 week of washout between each treatment and 1 week of follow-up Participants will be randomized to a treatment sequence 1-4 which will determine the order that they receive the dose levels during the four treatment periods of the study Neither participants nor study staff will know which dose a participant is receiving in any given treatment period All participants will receive all 4 dose levels and it is expected that each participant completes all four treatment periods in their assigned sequence The primary objective of this study is to evaluate the bronchodilator effect of twice daily inhaled glycopyrrolate solution over a dose range administered by standard jet nebulizer in subjects with COPD on Day 7 to support the selection of the glycopyrrolate doses for further clinical development in a fixed-dose combination with ensifentrine
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