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

First Received on September 2, 2005. No Changes Posted

Sponsor:	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

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:

MedlinePlus related topics: Antibiotics COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Erythromycin Gluceptate Erythromycin Erythromycin stearate Erythromycin ethylsuccinate Erythromycin estolate

U.S. FDA Resources

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

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):

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.

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:

Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Erythromycin stearate
Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate

Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on February 09, 2012