Effectiveness of Azithromycin Therapy in Improvement of Symptoms and Lung Function in Patients With Bronchiolitis Obliterans After Bone Marrow Transplantation
Azithromycin Therapy for Bronchiolitis Obliterans Syndrome After Allogenic Bone Marrow Transplantation
2 other identifiers
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2005
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 21, 2007
CompletedFirst Posted
Study publicly available on registry
November 26, 2007
CompletedJune 16, 2011
June 1, 2011
November 21, 2007
June 14, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Quality of life assessment by questionnaires
3 months after treatment
Spirometry
3 months after treatment
Interventions
Eligibility Criteria
You may qualify if:
- Confirmed BOS post BMT
- Informed consent
You may not qualify if:
- Women currently pregnant or nursing
- Allergy to macrolide
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Authority, Hong Konglead
- The University of Hong Kongcollaborator
- Pfizercollaborator
Study Sites (1)
Queen Mary Hospital
Hong Kong, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Albert Lie, Dr
Department of Medicine, Queen Mary Hospital/ The University of Hong Kong
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
November 21, 2007
First Posted
November 26, 2007
Study Start
April 1, 2005
Study Completion
March 1, 2007
Last Updated
June 16, 2011
Record last verified: 2011-06