Effectiveness of Azithromycin Therapy in Improvement of Symptoms and Lung Function in Patients With Bronchiolitis Obliterans After Bone Marrow Transplantation
Primary Purpose
Bronchiolitis Obliterans, Bone Marrow Transplantation
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Azithromycin
Placebo tablet
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiolitis Obliterans focused on measuring Bronchiolitis obliterans in bone marrow transplant recipients
Eligibility Criteria
Inclusion Criteria:
- Confirmed BOS post BMT
- Informed consent
Exclusion Criteria:
- Women currently pregnant or nursing
- Allergy to macrolide
Sites / Locations
- Queen Mary Hospital
Outcomes
Primary Outcome Measures
Quality of life assessment by questionnaires
Spirometry
Secondary Outcome Measures
Full Information
NCT ID
NCT00563251
First Posted
November 21, 2007
Last Updated
June 14, 2011
Sponsor
Hospital Authority, Hong Kong
Collaborators
The University of Hong Kong, Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00563251
Brief Title
Effectiveness of Azithromycin Therapy in Improvement of Symptoms and Lung Function in Patients With Bronchiolitis Obliterans After Bone Marrow Transplantation
Official Title
Azithromycin Therapy for Bronchiolitis Obliterans Syndrome After Allogenic Bone Marrow Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Authority, Hong Kong
Collaborators
The University of Hong Kong, Pfizer
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis Obliterans, Bone Marrow Transplantation
Keywords
Bronchiolitis obliterans in bone marrow transplant recipients
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Intervention Type
Drug
Intervention Name(s)
Placebo tablet
Primary Outcome Measure Information:
Title
Quality of life assessment by questionnaires
Time Frame
3 months after treatment
Title
Spirometry
Time Frame
3 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
Confirmed BOS post BMT
Informed consent
Exclusion Criteria:
Women currently pregnant or nursing
Allergy to macrolide
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Lie, Dr
Organizational Affiliation
Department of Medicine, Queen Mary Hospital/ The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
China
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Azithromycin Therapy in Improvement of Symptoms and Lung Function in Patients With Bronchiolitis Obliterans After Bone Marrow Transplantation
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