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

September 2, 2005
September 2, 2005
April 2004
Not Provided
  • Exacerbation Frequency
  • Airway Inflammation
Same as current
No Changes Posted
  • Lung Function
  • Health Status
  • Exacerbation Recovery Time
  • Symptoms
Same as current
Not Provided
Not Provided
 
Effects of Long Term Macrolide Antibiotic Therapy in Patients With COPD
Randomised Double Blind Placebo Controlled Trial of Effects of Long Term Low Dose Oral Erythromycin Therapy in Patients With Chronic Obstructive Pulmonary Disease

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
COPD
Drug: Erythromycin
Not Provided
Seemungal TA, Wilkinson TM, Hurst JR, Perera WR, Sapsford RJ, Wedzicha JA. Long-term erythromycin therapy is associated with decreased chronic obstructive pulmonary disease exacerbations. Am J Respir Crit Care Med. 2008 Dec 1;178(11):1139-47. Epub 2008 Aug 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
March 2006
Not Provided

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
Both
40 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00147667
P03/03
Not Provided
Not Provided
Royal Free and University College Medical School
Not Provided
Principal Investigator: Jadwiga A Wedzicha, MD Royal Free and University College Medical School
Royal Free and University College Medical School
March 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP