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Effects of Long Term Macrolide Antibiotic Therapy in Patients with COPD - Article


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Erythromycin Ophthalmic Ointment

Ilotycin



Clinical Trial: Effects of Long Term Macrolide Antibiotic Therapy in Patients with COPD

This study is no longer recruiting patients.

Sponsored by: 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

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

Further Study Details: 
Primary Outcomes: Exacerbation Frequency; Airway Inflammation
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

Ages Eligible for Study:  40 Years   -   90 Years,  Genders Eligible for Study:  Both
Criteria

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

Study chairs or principal investigators

Jadwiga A Wedzicha, MD,  Principal Investigator,  Royal Free and University College Medical School   

More Information

Study ID Numbers:  P03/03
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

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November 18, 2008



Page Updated: June 1, 2005
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