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

This study has been completed.
Sponsor:
Collaborators:
The University of Hong Kong
Pfizer
Information provided by:
Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:
NCT00563251
First received: November 21, 2007
Last updated: June 14, 2011
Last verified: June 2011
  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

Resource links provided by NLM:


Further study details as provided by Hospital Authority, Hong Kong:

Primary Outcome Measures:
  • Quality of life assessment by questionnaires [ Time Frame: 3 months after treatment ]
  • Spirometry [ Time Frame: 3 months after treatment ]

Estimated Enrollment: 30
Study Start Date: April 2005
Study Completion Date: March 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Confirmed BOS post BMT
  • Informed consent

Exclusion Criteria:

  • Women currently pregnant or nursing
  • Allergy to macrolide
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00563251

Locations
China
Queen Mary Hospital
Hong Kong, China
Sponsors and Collaborators
Hospital Authority, Hong Kong
The University of Hong Kong
Pfizer
Investigators
Principal Investigator: Albert Lie, Dr Department of Medicine, Queen Mary Hospital/ The University of Hong Kong
  More Information

No publications provided

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

Keywords provided by Hospital Authority, Hong Kong:
Bronchiolitis obliterans in bone marrow transplant recipients

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on April 17, 2014