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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    Recruiting
Updated on 23 November 2020

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 COPD (Chronic Obstructive Pulmonary Disease)
Clinical Study IdentifierTX249241
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 40 yrs and 80 yrs?
Gender: Male or Female
Do you have COPD (Chronic Obstructive Pulmonary Disease)?
Current or former cigarette smokers with a history of cigarette smoking ≥10 pack years at Screening (Visit 0) [number of pack years = (number of cigarettes per day / 20) × number of years smoked (eg, 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]
Pipe and/or cigar use cannot be used to calculate pack-year history
Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 0
Smoking cessation programs are permitted during the study
COPD Diagnosis: Patients with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines with symptoms compatible with COPD
Patients on no maintenance/background therapy or patients on stable maintenance LAMA or LABA therapy are eligible. Patients taking maintenance LAMA or LABA therapy must demonstrate stable use of the maintenance LAMA or LABA therapy for at least 3 months prior to Screening and agree to continue use for the duration of the study
Patients with COPD exacerbation requiring oral or parenteral steroids within 3 months of Screening not eligible
No long term oxygen use for greater than 12 hours per day. As needed oxygen use (≤12 hours per day) is not
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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