Effects of Long Term Macrolide Antibiotic Therapy in Patients With COPD
This trial is active, not recruiting.
|Phase||phase 2/phase 3|
|Sponsor||Royal Free and University College Medical School|
|Start date||April 2004|
|End date||March 2006|
|Trial size||120 participants|
|Trial identifier||NCT00147667, P03/03|
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.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
Exacerbation Recovery Time
Male or female participants from 40 years up to 90 years old.
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
|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|
|Principal investigator||Jadwiga A Wedzicha, MD|
|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.|
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