Phase 2 Study - Erdosteine in Patients With CB/COPD

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00338507

Enrollment

400

Registered

2006-06-20

Start date

2006-03-31

Completion date

Unknown

Last updated

2007-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Bronchitis, Chronic Obstructive Pulmonary Disease

Keywords

Chronic Bronchitis, Chronic Obstructive Pulmonary Disease

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.

Interventions

DRUGErdosteine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

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;

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026