Effects of Long Term Macrolide Antibiotic Therapy in Patients With COPD

Sponsor

Royal Free and University College Medical School (Other)

Overall Status

Unknown status

CT.gov ID

NCT00147667

Collaborator

(none)

120

Enrollment

Location

Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
COPD	Drug: Erythromycin	Phase 2/Phase 3

Detailed 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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double

Primary Purpose:

Treatment

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

Study Start Date :

Apr 1, 2004

Study Completion Date :

Mar 1, 2006

Outcome Measures

Primary Outcome Measures

Exacerbation Frequency []
Airway Inflammation []

Secondary Outcome Measures

Lung Function []
Health Status []
Exacerbation Recovery Time []
Symptoms []

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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