Phase 2 Study - Erdosteine in Patients With CB/COPD

This study has been completed.
Sponsor:
Information provided by:
Adams Respiratory Therapeutics
ClinicalTrials.gov Identifier:
NCT00338507
First received: June 16, 2006
Last updated: December 5, 2007
Last verified: December 2007
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


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
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, see Learn About Clinical Studies.

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

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

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

Additional relevant MeSH terms:
Bronchitis
Bronchitis, Chronic
Pulmonary Disease, Chronic Obstructive
Acute Disease
Lung Diseases
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Erdosteine
Expectorants
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014