HAREC Clinical Trial Registry Record
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Title for Public Effectiveness of azithromycin therapy in improvement of symptoms and lung function in patients with bronchiolitis obliterans after bone marrow transplantation
HAREC ID HARECCTR0500038
Scientific Title Azithromycin therapy for bronchiolitis obliterans syndrome after allogenic bone marrow transplantation

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.

Trial ID
HA REC Trial ID UW 04-165 T/487
Name of CREC HKU/HA/HKW IRB

Other Trial IDs
ID Number
Issuing Authority
 
Lead Principal Investigator
Name Dr   Albert   Lie
Department/Unit Medicine/
Institute/Hospital Queen Mary Hospital/ The University of Hong Kong

Contact person
Name Dr   Albert   Lie
Department/Unit Medicine/
Institute/Hospital Queen Mary Hospital/ The University of Hong Kong
Phone 2855 3975
Fax 2872 6896
Internet Mail akwlie@hkucc.hku.hk

Disease/s or Condition/s
Bronchiolitis obliterans in bone marrow transplant recipients

Intervention/s
Intervention 1
Intervention Name Azithromycin
Type of Intervention Drug
Duration 3 Months
Other details
Active Control NO
Intervention 2
Intervention Name Placebo tablet
Type of Intervention Drug
Duration 3 Months
Other details
Active Control NO

Inclusion and Exclusion Criteria
Gender Non-specific
Age >18
Inclusion and Exclusion Criteria Inclusion Criteria (pre-op):
- Confirmed BOS post BMT
- Informed consent
Exclusion Criteria (pre-op):
- Women currently pregnant or nursing
- Allergy to macrolide

Study Type Interventional
Purpose Treatment
Allocation Randomized controlled trial
Masking Double blind
Control Placebo
Assignment Parallel
Endpoint Safety/efficacy

Primary Outcome/s
Outcome name Quality of life assessment by questionnaires
Timepoint 3 months after treatment
Outcome name Spirometry
Timepoint 3 months after treatment

Secondary Outcome/s
Outcome name
Timepoint

Date of First Enrollment 2005-04-01
(yyyy-mm-dd)

Target Sample Size 30

Recruitment Status Completed

Funding Source/s
Name Pfizer Corporation Hong Kong Ltd
Address or contact information 16/F., Stanhope House, 738 King's Road, North Point, Hong Kong

Primary Sponsor
Name The University of Hong Kong
Address or contact information The University of Hong Kong, Pokfulam, Hong Kong

Secondary Sponsor
Name Pfizer Corporation Hong Kong Ltd
Address or contact information 16/F., Stanhope House, 738 King's Road, North Point, Hong Kong

Research Ethics Board/Committee Approval YES

Co-Investigator/s
Name Dr Bing Lam
Department Medicine
Organization The University of Hong Kong


Study Site/s
Local site/s Department Organization
1 Medicine Queen Mary Hospital

Clinical Specialty Internal Medicine

Proposed Date of Last Follow-up 2007-03-26
(yyyy-mm-dd)

Registration Date 2005-09-12
(yyyy-mm-dd)

Submission Date 2005-09-12
(yyyy-mm-dd)

Record Status Verified; registration accepted - complete data. August 2007