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

History of Changes

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:

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

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

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
Respiration Disorders
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 June 17, 2013

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