Phase 2 Study - Erdosteine in Patients With CB/COPD

This clinical study is designed to explore dose ranging and identify methods to demonstrate the efficacy of Erdosteine in patients with stable Chronic Bronchitis associated with Chronic Obstructive Pulmonary Disease.

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Key information

Conditions

Chronic Bronchitis Bronchial Diseases Bronchitis Bronchitis, Chronic Chronic Disease Chronic Obstructive Pulmonary Disease Disease Attributes Infections Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Omnicare Clinical Research

King of Prussia, Pennsylvania, 19406, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult patients with a clinical diagnosis of stable CB associated with COPD will be entered into this study. CB is diagnosed clinically in patients who have a documented smoking history and who have a daily productive cough for at least 3 months per year over at least 2 consecutive years in the absence of other causes of chronic cough. COPD is defined by the presence of airflow obstruction from spirometry

Exclusion criteria

asthma, bronchiectasis, or cystic fibrosis; active history of lung cancer, respiratory failure, or a need for long-term oxygen therapy;

Treatment and study plan

Erdosteine

Drug

Sponsors and collaborators

Lead sponsor

Adams Respiratory Therapeutics

Industry

Registry information

Official study title

A Randomized, Double-Blind, Parallel-Group, Multicenter, Placebo-Controlled Dose_Ranging Study of Erdosteine for the Treatment of Stable Chronic Bronchitis Associated With Chronic Obstructive Pulmonary Disease

Important dates

Study start: 2006
First posted: Jun 20, 2006
Registry last updated: Dec 6, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed