Effects of Long Term Macrolide Antibiotic Therapy in Patients With COPD

Condition(s) targeted: COPD

Intervention: Erythromycin (Drug)

Phase: Phase 2/Phase 3

Status: Active, not recruiting

Sponsored by: Royal Free and University College Medical School

Official(s) and/or principal investigator(s):
Jadwiga A Wedzicha, MD, Principal Investigator, Affiliation: Royal Free and University College Medical School

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.

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome:

Exacerbation Frequency

Airway Inflammation

Secondary outcome:

Lung Function

Health Status

Exacerbation Recovery Time

Symptoms

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.

Minimum age: 40 Years. Maximum age: 90 Years. Gender(s): Both.

Criteria:

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

Royal Free Hospital, London, England NW3 1PF, United Kingdom

Starting date: April 2004
Last updated: September 2, 2005