Back to resultsPhase 2 Study - Erdosteine in Patients With CB/COPD
Primary Purpose
Chronic Bronchitis, Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Erdosteine
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Bronchitis focused on measuring Chronic Bronchitis, Chronic Obstructive Pulmonary Disease
Eligibility 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;
Sites / Locations
- Omnicare Clinical Research
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00338507
First Posted
June 16, 2006
Last Updated
December 5, 2007
Sponsor
Adams Respiratory Therapeutics
1. Study Identification
Unique Protocol Identification Number
NCT00338507
Brief Title
Phase 2 Study - Erdosteine in Patients With CB/COPD
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 Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Adams Respiratory Therapeutics
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Bronchitis, Chronic Obstructive Pulmonary Disease
Keywords
Chronic Bronchitis, Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
400 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Erdosteine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helmut Albrecht, MD
Organizational Affiliation
Adams Respiratory Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Omnicare Clinical Research
City
King of Prussia
State/Province
Pennsylvania
ZIP/Postal Code
19406
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Phase 2 Study - Erdosteine in Patients With CB/COPD
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