|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Hospital Authority, Hong Kong |
|---|---|
| Collaborators: |
The University of Hong Kong Pfizer |
| Information provided by: | Hospital Authority, Hong Kong |
| ClinicalTrials.gov Identifier: | NCT00563251 |
Purpose
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 | Intervention |
|---|---|
|
Bronchiolitis Obliterans Bone Marrow Transplantation |
Drug: Azithromycin Drug: Placebo tablet |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Azithromycin Therapy for Bronchiolitis Obliterans Syndrome After Allogenic Bone Marrow Transplantation |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| China | |
| Queen Mary Hospital | |
| Hong Kong, China | |
| Principal Investigator: | Albert Lie, Dr | Department of Medicine, Queen Mary Hospital/ The University of Hong Kong |
More Information
| ClinicalTrials.gov Identifier: | NCT00563251 History of Changes |
| Other Study ID Numbers: | UW 04-165 T/487, HARECCTR0500038 |
| Study First Received: | November 21, 2007 |
| Last Updated: | June 14, 2011 |
| Health Authority: | Hong Kong: Ethics Committee |
|
Bronchiolitis obliterans in bone marrow transplant recipients |
|
Bronchiolitis Bronchiolitis Obliterans Bronchitis Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Tract Infections Azithromycin Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |