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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)

NCT04600778 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2020-10-23

No results posted yet for this study

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

OTHER

placebo

placebo

DRUG

Cavosonstat 5 mg

Cavosonstat (low dose)

DRUG

Cavosonstat 10 mg

Cavosonstat (medium dose)

DRUG

Cavosonstat 25 mg

Cavosonstat (high dose)

Sponsors & Collaborators

  • GSNOR Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-03
Primary Completion
2021-12-31
Completion
2022-04-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04600778 on ClinicalTrials.gov