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Effects of Long Term Macrolide Antibiotic Therapy in Patients With COPD

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2004 by Royal Free and University College Medical School.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Royal Free and University College Medical School
ClinicalTrials.gov Identifier:
NCT00147667
First received: September 2, 2005
Last updated: NA
Last verified: March 2004
History: No changes posted
  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
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

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

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Royal Free and University College Medical School

Additional 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
Study First Received: September 2, 2005
Last Updated: September 2, 2005
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014