ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase 2 Study - Erdosteine in Patients With CB/COPD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00338507
Recruitment Status : Completed
First Posted : June 20, 2006
Last Update Posted : December 6, 2007
Sponsor:
Information provided by:
Adams Respiratory Therapeutics

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Bronchitis Chronic Obstructive Pulmonary Disease Drug: Erdosteine Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : March 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources





Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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;


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00338507     History of Changes
Other Study ID Numbers: ERD-CB-01-2005
First Posted: June 20, 2006    Key Record Dates
Last Update Posted: December 6, 2007
Last Verified: December 2007

Keywords provided by Adams Respiratory Therapeutics:
Chronic Bronchitis
Chronic Obstructive Pulmonary Disease

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Bronchitis
Bronchitis, Chronic
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bronchial Diseases
Respiratory Tract Infections
Erdosteine
Expectorants
Respiratory System Agents