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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Cavosonstat Administered Twice Daily Compared With Placebo for 24 Weeks in Adult Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Cavosonstat Administered Twice Daily Compared With Placebo for 24 Weeks in Adult Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trial Summary

Brief Summary: The purpose of this study is to to evaluate the efficacy and safety of Cavosonstat administered twice daily compared with Placebo for 24 Weeks in adult subjects with Chronic Obstructive Pulmonary Disease (COPD) Detailed Description:To investigate the effect of cavosonstat compared with placebo, on the annualized rate of moderate-to-severe acute exacerbations of COPD (AECOPD) over 24 weeks of treatment. To investigate: 1. The effect of cavosonstat compared with placebo, on the duration from baseline to first moderate AECOPD event 2. The effect of cavosonstat compared with placebo, on respiratory function, as assessed by post-bronchodilator percent-predicted forced expiratory volume in one second (ppFEV1) 3. The effect of cavosonstat compared with placebo on annualized rate of moderate AECOPD over 24 weeks of treatment 4. The effect of cavosonstat compared with placebo on annualized rate of severe AECOPD over 24 weeks of treatment 5. The safety and tolerability of cavosonstat compared with placebo 6. The pharmacokinetics of cavosonstat 7. Assessment of quality of life

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04600778
Study type Interventional
Source GSNOR Therapeutics, Inc.
Contact
Status Not yet recruiting
Phase Phase 2
Start date February 3, 2021
Completion date April 30, 2022
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