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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: Erythromycin

Primary Measures

• Exacerbation Frequency
• Airway Inflammation

Secondary Measures

• Lung Function
• Health Status
• Exacerbation Recovery Time
• Symptoms

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 90 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Royal Free and University College Medical School

Overall Clinical Trial Officials and Contacts

Jadwiga A Wedzicha, MD Principal Investigator Royal Free and University College Medical School  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00147667

Study ID Number: P03/03

ClinicalTrials.gov Identifier: NCT00147667

Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency