The Efficacy and Safety of Erdosteine in Chronic Obstructive Pulmonary Disease (COPD)

Phase 3

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Drug: Placebo; Drug: Erdosteine

• Registration Number: NCT01032304
• Lead Sponsor: Edmond Pharma

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-12-11
• Study First Submitted QC: 2009-12-13
• Study First Posted: 2009-12-15
• Primary Completion: 2014-03
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-12
• Last Update Posted: 2014-06-13
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 492

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo for 12 months
Erdosteine	Erdosteine	600 mg/day for 12 months

Primary Outcome Measures

Name	Time	Method
number of acute exacerbations	12 months

Secondary Outcome Measures

Name	Time	Method
spirometry parameters	12 months
COPD symptoms	12 months
Quality of life	12 months
Safety and tolerability of erdosteine	12 months

Trial Locations

Locations (44)

Campus Gasthuisberg Dep.t Longfunctiemetingen; 🇧🇪 Leuven, Belgium

ASMOH-MC "Sveti Panteleiomon"; 🇧🇬 Sofia, Bulgaria

Clinic for emergency Medicine and Intensive care, Pneumology and Physiatry; 🇧🇬 Sofia, Bulgaria

Clinic of Pulmonary Disease-Military Medical Academy; 🇧🇬 Sofia, Bulgaria

Clinical of Pneumology and Physiatry; 🇧🇬 Varna, Bulgaria

Plicnì Ordinace; 🇨🇿 Strakonice, Czech Republic

Poliklinica Moravsky Krumlov; 🇨🇿 Moravsky Krumlov, Czech Republic

Department of Respiratory Medicine, Faculty Hospital; 🇨🇿 Olomouc, Czech Republic

Lipa Centrum Nove Butovice; 🇨🇿 Praha, Czech Republic

Lerymed spol. s.r.o.; 🇨🇿 Praha, Czech Republic

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