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

• Sponsor: Hospital Authority, Hong Kong (Other)
• Overall Status: Completed
• CT.gov ID: NCT00563251
• Collaborator: The University of Hong Kong (Other), Pfizer (Industry)
• Enrollment: 30
• Location: 1
• Duration (Months): 23
• Patients Per Site Per Month: 1.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bronchiolitis Obliterans; Bone Marrow Transplantation	Drug: Azithromycin; Drug: Placebo tablet	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Azithromycin Therapy for Bronchiolitis Obliterans Syndrome After Allogenic Bone Marrow Transplantation
• Study Start Date: Apr 1, 2005
• Actual Study Completion Date: Mar 1, 2007

Outcome Measures

Primary Outcome Measures

1. Quality of life assessment by questionnaires [3 months after treatment]

2. Spirometry [3 months after treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

• Confirmed BOS post BMT

• Informed consent

Exclusion Criteria:

• Women currently pregnant or nursing

• Allergy to macrolide

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• HAREC Clinical Trial Registry

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00563251
• Other Study ID Numbers: UW 04-165 T/487; HARECCTR0500038
• First Posted: Nov 26, 2007
• Last Update Posted: Jun 16, 2011
• Last Verified: Jun 1, 2011

• Keywords provided by , ,: Bronchiolitis obliterans in bone marrow transplant recipients
• Additional relevant MeSH terms: Bronchiolitis; Bronchiolitis Obliterans; Azithromycin

Study Results

No Results Posted as of Jun 16, 2011