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Effects of Long Term Macrolide Antibiotic Therapy in Patients With COPD

Randomised Double Blind Placebo Controlled Trial of Effects of Long Term Low Dose Oral Erythromycin Therapy in Patients With Chronic Obstructive Pulmonary Disease

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00147667
Enrollment
120
Registered
2005-09-07
Start date
2004-04-30
Completion date
2006-03-31
Last updated
2005-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Keywords

COPD, EXACERBATIONS, AIRWAY INFLAMMATION

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.

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.

Interventions

DRUGErythromycin

Sponsors

Royal Free and University College Medical School
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Exacerbation Frequency
Airway Inflammation

Secondary

MeasureTime frame
Lung Function
Health Status
Exacerbation Recovery Time
Symptoms

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026