Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
NCT ID:
NCT07016412
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:
NCT07016412
Study Brief:
Protocol Section:
NCT07016412