Effectiveness of Azithromycin Therapy in Improvement of Symptoms and Lung Function in Patients With Bronchiolitis Obliterans After Bone Marrow Transplantation
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|ClinicalTrials.gov Identifier: NCT00563251|
Recruitment Status : Completed
First Posted : November 26, 2007
Last Update Posted : June 16, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Bronchiolitis Obliterans Bone Marrow Transplantation||Drug: Azithromycin Drug: Placebo tablet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Azithromycin Therapy for Bronchiolitis Obliterans Syndrome After Allogenic Bone Marrow Transplantation|
|Study Start Date :||April 2005|
|Actual Study Completion Date :||March 2007|
- Quality of life assessment by questionnaires [ Time Frame: 3 months after treatment ]
- Spirometry [ Time Frame: 3 months after treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00563251
|Queen Mary Hospital|
|Hong Kong, China|
|Principal Investigator:||Albert Lie, Dr||Department of Medicine, Queen Mary Hospital/ The University of Hong Kong|