Bronchiolitis obliterans syndrome (BOS), an obstructive airway disease as a result of chronic rejection, is one of the major causes of morbidity and mortality in long-term survivors of allogeneic bone marrow transplantation (BMT). Although augmentation of immunosuppressive treatment might help but the only effective treatment for BOS is by lung transplantation. Macrolide antibiotics, which have...
Date First Received: November 21, 2007
Last Updated: June 17, 2008
Verified by: Hospital Authority, Hong Kong, June 2008
Clinical Trial Phase: N/A | Start Date: April 2005
Overall Status: Completed
Estimated Enrollment: 30
Brief Summary
Official Title: “Azithromycin Therapy for Bronchiolitis Obliterans Syndrome After Allogenic Bone Marrow Transplantation”
Condition Keyword(s):
Intervention(s):
Bronchiolitis obliterans syndrome (BOS), an obstructive airway disease as a result of chronic rejection, is one of the major causes of morbidity and mortality in long-term survivors of allogeneic bone marrow transplantation (BMT). Although augmentation of immunosuppressive treatment might help but the only effective treatment for BOS is by lung transplantation.
Macrolide antibiotics, which have been licensed to use as antibacterial agents for decades, have been found to have immunomodulatory properties in addition to their antibacterial activity. Low dose Azithromycin, an antibiotic of the macrolide family, has been shown to have promising result in a pilot study in treating BOS associated with lung transplantation.
We propose to perform a prospective, randomised, double blind study to test the efficacy of Azithromycin in treating BOS after BMT. Patients with proven BOS after BMT will be randomised into two groups based on lung function parameters. One group will receive low dose Azithromycin while placebo will be provided for the other group. Lung function will be serially monitored at 3 month, 6 months and 12 months after commencement of treatment with drug/placebo. If Azithromycin was proven effective in treating BOS then all patient with proven BOS should be treated with this drug.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Azithromycin
- Drug: Placebo tablet
Outcome Measures for this Clinical Trial
Primary Measures
- Quality of life assessment by questionnaires
- Time Frame: 3 months after treatment
- Time Frame: 3 months after treatment
- Spirometry
- Time Frame: 3 months after treatment
- Time Frame: 3 months after treatment
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Confirmed BOS post BMT
- Informed consent
Exclusion Criteria:
- Women currently pregnant or nursing
- Allergy to macrolide
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Clinical Trial Sponsor Information
Lead Sponsor: Hospital Authority, Hong Kong
Overall Clinical Trial Officials and Contacts
Albert Lie, Dr Principal Investigator Department of Medicine, Queen Mary Hospital/ The University of Hong Kong
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00563251
Study ID Number: UW 04-165 T/487
ClinicalTrials.gov Identifier: NCT00563251
Health Authority: Hong Kong: Ethics Committee
Clinical Trials Authorship and Review
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