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Effects of Long Term Macrolide Antibiotic Therapy in Patients With COPD

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2004 by Royal Free and University College Medical School.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00147667
First Posted: September 7, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Royal Free and University College Medical School
  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 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
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

Resource links provided by NLM:


Further study details as provided by Royal Free and University College Medical School:

Primary Outcome Measures:
  • Exacerbation Frequency
  • Airway Inflammation

Secondary Outcome Measures:
  • Lung Function
  • Health Status
  • Exacerbation Recovery Time
  • Symptoms

Estimated Enrollment: 120
Study Start Date: April 2004
Estimated Study Completion Date: March 2006
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00147667


Locations
United Kingdom
Royal Free Hospital
London, England, United Kingdom, NW3 1PF
Sponsors and Collaborators
Royal Free and University College Medical School
Investigators
Principal Investigator: Jadwiga A Wedzicha, MD Royal Free and University College Medical School
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00147667     History of Changes
Other Study ID Numbers: P03/03
First Submitted: September 2, 2005
First Posted: September 7, 2005
Last Update Posted: December 9, 2005
Last Verified: March 2004

Keywords provided by Royal Free and University College Medical School:
COPD
EXACERBATIONS
AIRWAY INFLAMMATION

Additional relevant MeSH terms:
Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action