Effects of Long Term Macrolide Antibiotic Therapy in Patients With COPD

COPD Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00147667
• Other study ID #: P03/03
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: September 2, 2005
• Last updated: September 2, 2005
• Start date: April 2004
• Est. completion date: March 2006

Study information

• Verified date: March 2004
• Source: Royal Free and University College Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 90 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• COPD

Intervention

Drug:
• Erythromycin

Locations

Country	Name	City	State
United Kingdom	Royal Free Hospital	London	England

Sponsors (1)

Lead Sponsor	Collaborator
Royal Free and University College Medical School

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exacerbation Frequency
Primary	Airway Inflammation
Secondary	Lung Function
Secondary	Health Status
Secondary	Exacerbation Recovery Time
Secondary	Symptoms