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The Efficacy and Safety of Erdosteine in Chronic Obstructive Pulmonary Disease (COPD) | Clinical Trials | Clareo Health

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

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

NCT01032304•Edmond Pharma

View on ClinicalTrials.gov

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.

Eligibility

Age

40 - 80 years

Sex

ALL

Healthy Volunteers

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

Locations (46)

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

Havlìckuv Brod, Czechia

Poliklinica Moravsky Krumlov

Moravský Krumlov, Czechia

Department of Respiratory Medicine, Faculty Hospital

Olomouc, Czechia

Lipa Centrum Nove Butovice

Prague, Czechia

Lerymed spol. s.r.o.

Prague, Czechia

Key Dates

Start Date

August 1, 2009

Primary Completion Date

March 1, 2014

Completion Date

September 1, 2015

Last Updated

June 13, 2014

Enrollment

492

ESTIMATED participants

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Erdosteine

DRUG

Placebo

DRUG

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Chronic Obstructive Pulmonary Disease (COPD)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 13, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

cfMSC Stem Cell Therapy Targeting COPD

A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease

Mindful-Breath for People With COPD

The HELlenic Thoracic Society Initiative for CΟPD and CVD

Magnetic Stimulation of Diaphragm in Chronic Obstructive Pulmonary Disease

COPD Exacerbation Modelling Using Unobtrusive Sensors - the TOLIFE Clinical Study A