Overview

This trial is active, not recruiting.

Condition chronic obstructive pulmonary disease (copd)
Treatments erdosteine, placebo
Phase phase 3
Sponsor Edmond Pharma
Start date August 2009
End date March 2014
Trial size 492 participants
Trial identifier NCT01032304, ERD-01-08/EP

Summary

The aim of the study is to evaluate the effect of erdosteine, compared to placebo, on exacerbation rate over a 12-month treatment period in patients with moderate-to-severe COPD. Moreover, the effects of erdosteine on pulmonary function parameters, clinical symptoms and quality of life, and the long-term safety of the drug will be assessed.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
600 mg/day for 12 months
erdosteine
One 300 mg capsule twice a day
(Placebo Comparator)
Placebo for 12 months
placebo
One capsule twice a day

Primary Outcomes

Measure
number of acute exacerbations
time frame: 12 months

Secondary Outcomes

Measure
spirometry parameters
time frame: 12 months
COPD symptoms
time frame: 12 months
Quality of life
time frame: 12 months
Safety and tolerability of erdosteine
time frame: 12 months

Eligibility Criteria

Male or female participants from 40 years up to 80 years old.

Inclusion Criteria: - COPD stage II-III GOLD - At least 2 exacerbations in the previous 2-12 months Exclusion Criteria: - Acute exacerbations in the 2 months prior to enrolment - Diagnosis of asthma and/or other relevant lung diseases - COPD stage IV - Unstable concurrent diseases

Additional Information

Official title The Efficacy and Safety of Erdosteine in the Long-term Therapy of Chronic Obstructive Pulmonary Disease (COPD). A 12-month, Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicenter Study
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by Edmond Pharma.