Phase 2 Study - Erdosteine in Patients With CB/COPD

This study has been completed.

First Received: June 16, 2006 Last Updated: December 5, 2007 History of Changes

Sponsored by:	Adams Respiratory Therapeutics
Information provided by:	Adams Respiratory Therapeutics
ClinicalTrials.gov Identifier:	NCT00338507

Purpose

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.

Condition	Intervention	Phase
Chronic Bronchitis Chronic Obstructive Pulmonary Disease	Drug: Erdosteine	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official 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

Resource links provided by NLM:

MedlinePlus related topics: Bronchitis COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Erdosteine

U.S. FDA Resources

Further study details as provided by Adams Respiratory Therapeutics:

Estimated Enrollment:	400
Study Start Date:	March 2006

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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;

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00338507

Locations

United States, Pennsylvania
Omnicare Clinical Research
King of Prussia, Pennsylvania, United States, 19406

Sponsors and Collaborators

Adams Respiratory Therapeutics

Investigators

Study Director:

Helmut Albrecht, MD

Adams Respiratory Therapeutics

More Information

No publications provided

Study ID Numbers:	ERD-CB-01-2005
Study First Received:	June 16, 2006
Last Updated:	December 5, 2007
ClinicalTrials.gov Identifier:	NCT00338507 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Adams Respiratory Therapeutics:

Chronic Bronchitis
Chronic Obstructive Pulmonary Disease

Study placed in the following topic categories:

Bronchitis, Chronic
Lung Diseases, Obstructive
Respiratory Tract Infections
Respiratory Tract Diseases
Bronchial Diseases
Expectorants

Lung Diseases
Respiration Disorders
Bronchitis
Erdosteine
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Respiratory System Agents
Bronchial Diseases
Respiration Disorders
Erdosteine
Pharmacologic Actions
Bronchitis, Chronic
Lung Diseases, Obstructive

Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases
Expectorants
Therapeutic Uses
Bronchitis
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on September 02, 2009