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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
Hospital Authority, Hong Kong
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiolitis Obliterans focused on measuring Bronchiolitis obliterans in bone marrow transplant recipients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

First Posted
November 21, 2007
Last Updated
June 14, 2011
Sponsor
Hospital Authority, Hong Kong
Collaborators
The University of Hong Kong, Pfizer
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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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