Phase 2 Study - Erdosteine in Patients With CB/COPD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Bronchitis Chronic Obstructive Pulmonary Disease

Keywords

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Chronic Bronchitis Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Erdosteine

Intervention Type DRUG

Eligibility Criteria

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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;

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Helmut Albrecht, MD

Role: STUDY_DIRECTOR

Adams Respiratory Therapeutics

Locations

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Omnicare Clinical Research

King of Prussia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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ERD-CB-01-2005

Identifier Type: -

Identifier Source: org_study_id