A Phase III Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ensifentrine over 24 Weeks in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease.

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Updated on 22 September 2023

Summary

This study will enroll approximately 800 patients with moderate to severe COPD in 2 subsets.
The 24-week subset will enroll approximately 400 patients randomized 1:1 ensifentrine (3 mg): placebo and the 48-week subset will enroll approximately 400 patients randomized 3:1 in order to minimize the number of patients assigned to placebo over 48 weeks.
The assessments in each subset are identical over the first 24 weeks. The 48-week subset will continue to assess long-term safety in this subset of patients. 
Both studies will assess lung function, symptoms, and quality of life over 24 weeks. Safety and tolerability will be assessed over 24 or 48 weeks.

Description

Participants will be compensated for study participation.

Details
Condition Chronic Obstructive Pulmonary Disease, COPD, COPD (Chronic Obstructive Pulmonary Disease)
Clinical Study IdentifierTX249241
Last Modified on22 September 2023

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