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Phase 2 Study - Erdosteine in Patients With CB/COPD

A

Adams Respiratory Therapeutics

Status and phase

Completed
Phase 2

Conditions

Chronic Bronchitis
Chronic Obstructive Pulmonary Disease

Treatments

Drug: Erdosteine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00338507
ERD-CB-01-2005

Details and patient eligibility

About

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.

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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;

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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