Effectiveness of Azithromycin Therapy in Improvement of Symptoms and Lung Function in Patients With Bronchiolitis Obliterans After Bone Marrow Transplantation

Not Applicable

Completed

• Conditions: Bronchiolitis Obliterans; Bone Marrow Transplantation

• Registration Number: NCT00563251
• Lead Sponsor: Hospital Authority, Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Study Completion: 2007-03
• Study First Submitted: 2007-11-21
• Study First Submitted QC: 2007-11-21
• Study First Posted: 2007-11-26
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-14
• Last Update Posted: 2011-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Confirmed BOS post BMT
• Informed consent

Exclusion Criteria

• Women currently pregnant or nursing
• Allergy to macrolide

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Quality of life assessment by questionnaires	3 months after treatment
Spirometry	3 months after treatment

Trial Locations

Locations (1)

Queen Mary Hospital; 🇨🇳 Hong Kong, China