Erythromycin Ophthalmic Ointment |
Ilotycin |
Clinical Trial: Effects of Long Term Macrolide Antibiotic Therapy in Patients with COPD
This study is no longer recruiting patients.
|
Purpose
| Condition | Intervention | Phase |
|---|---|---|
| COPD | Drug: Erythromycin | Phase II Phase III |
MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
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
Secondary Outcomes: Lung Function; Health Status; Exacerbation Recovery Time; Symptoms
Expected Total Enrollment: 120
Study start: April 2004; Study completion: May 2006
Last follow-up: March 2006; Data entry closure: April 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
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
Location Information
United Kingdom, England
Royal Free Hospital, London, England, NW3 1PF, United Kingdom
Jadwiga A Wedzicha, MD, Principal Investigator, Royal Free and University College Medical School
More Information
Last Updated: September 6, 2005
Record first received: September 2, 2005
ClinicalTrials.gov Identifier: NCT00147667
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
ClinicalTrials.gov processed this record on 2005-09-13
Resources
- Erythromycin Ophthalmic Ointment (Drug Digest)
- Ilotycin (Drug Digest)

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