Overview

This trial is active, not recruiting.

Condition copd
Treatment erythromycin
Phase phase 2/phase 3
Sponsor Royal Free and University College Medical School
Start date April 2004
End date March 2006
Trial size 120 participants
Trial identifier NCT00147667, P03/03

Summary

The purpose of this study is to determine whether long term treatment with oral erythromycin is effective in the treatment of subjects with Chronic Obstructive Pulmonary Disease (COPD) by reducing the number of exacerbations and the degree of airway inflammation.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

Measure
Exacerbation Frequency
time frame:
Airway Inflammation
time frame:

Secondary Outcomes

Measure
Lung Function
time frame:
Health Status
time frame:
Exacerbation Recovery Time
time frame:
Symptoms
time frame:

Eligibility Criteria

Male or female participants from 40 years up to 90 years old.

Inclusion Criteria: - Clinical Diagnosis of COPD - Clinically stable for 6 weeks - Able to Swallow Tablets Exclusion Criteria: - Clinically significant respiratory disease other than COPD - Women of child bearing age - Patients receiving existing Medication which may interact adversely with trial drug - History of clinically significant liver disease

Additional Information

Official title Randomised Double Blind Placebo Controlled Trial of Effects of Long Term Low Dose Oral Erythromycin Therapy in Patients With Chronic Obstructive Pulmonary Disease
Principal investigator Jadwiga A Wedzicha, MD
Description COPD is characterised by persisting airway inflammation which leads to a progressive and irreversible deterioration in lung function with the eventual development of respiratory symptoms which may become disabling. Periodic episodes of worsening symptoms or exacerbations are a major cause of additional morbidity, mortality and health care utilization. Currently available therapies have limited efficacy in reducing airway inflammation or preventing exacerbations. Macrolides such as erythromycin have been shown to have potent anti-inflammatory effects in in vitro experiments and in other lung conditions such as cystic fibrosis and bronchiectasis as well as in open label studies in COPD. We hypothesised that long term therapy with oral erythromycin would reduce airway inflammation and reduce the frequency of exacerbations in patients with COPD. If these properties are demonstrated this therapy can have potentially important benefits if effective in this condition.
Trial information was received from ClinicalTrials.gov and was last updated in September 2005.
Information provided to ClinicalTrials.gov by Royal Free and University College Medical School.