Effectiveness of Azithromycin Therapy in Improvement of Symptoms and Lung Function in Patients With Bronchiolitis Obliterans After Bone Marrow Transplantation
Information source: Hospital Authority, Hong Kong
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bronchiolitis Obliterans; Bone Marrow Transplantation
Intervention: Azithromycin (Drug); Placebo tablet (Drug)
Phase: N/A
Status: Completed
Sponsored by: Hospital Authority, Hong Kong Official(s) and/or principal investigator(s):
Albert Lie, Dr, Principal Investigator, Affiliation: Department of Medicine, Queen Mary Hospital/ The University of Hong Kong
Summary
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.
Clinical Details
Official title: Azithromycin Therapy for Bronchiolitis Obliterans Syndrome After Allogenic Bone Marrow Transplantation
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Quality of life assessment by questionnairesSpirometry
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Confirmed BOS post BMT
- Informed consent
Exclusion Criteria:
- Women currently pregnant or nursing
- Allergy to macrolide
Locations and Contacts
Queen Mary Hospital, Hong Kong, China
Additional Information
HAREC Clinical Trial Registry
Starting date: April 2005
Ending date: March 2007
Last updated: June 17, 2008
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