NCT04600778

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)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: GSNOR Therapeutics, Inc. · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
OTHER	placebo	placebo
DRUG	Cavosonstat 5 mg	Cavosonstat (low dose)
DRUG	Cavosonstat 10 mg	Cavosonstat (medium dose)
DRUG	Cavosonstat 25 mg	Cavosonstat (high dose)

Timeline

• Start date: 2021-02-03
• Primary completion: 2021-12-31
• Completion: 2022-04-30
• First posted: 2020-10-23
• Last updated: 2020-10-23

Regulatory

• FDA-regulated drug study