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| Sponsor: | Royal Free and University College Medical School |
|---|---|
| Information provided by: | Royal Free and University College Medical School |
| ClinicalTrials.gov Identifier: | NCT00147667 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
COPD |
Drug: Erythromycin |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Control: Placebo Control Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind 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 |
| Estimated Enrollment: | 120 |
| Study Start Date: | April 2004 |
| Estimated Study Completion Date: | March 2006 |
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.
Eligibility| Ages Eligible for Study: | 40 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United Kingdom, England | |
| Royal Free Hospital | |
| London, England, United Kingdom, NW3 1PF | |
| Principal Investigator: | Jadwiga A Wedzicha, MD | Royal Free and University College Medical School |
More Information
| Study ID Numbers: | P03/03 |
| Study First Received: | September 2, 2005 |
| Last Updated: | September 2, 2005 |
| ClinicalTrials.gov Identifier: | NCT00147667 History of Changes |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
COPD EXACERBATIONS AIRWAY INFLAMMATION |
|
Erythromycin stearate Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Erythromycin Ethylsuccinate Gastrointestinal Agents Enzyme Inhibitors Erythromycin Pharmacologic Actions |
Anti-Bacterial Agents Protein Synthesis Inhibitors Lung Diseases, Obstructive Respiratory Tract Diseases Erythromycin Estolate Lung Diseases Therapeutic Uses Pulmonary Disease, Chronic Obstructive |
