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NCT00563251 Clinical Trial

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

Bronchiolitis Obliterans Clinical Trial

Official title:
Azithromycin Therapy for Bronchiolitis Obliterans Syndrome After Allogenic Bone Marrow Transplantation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00563251
Other study ID # UW 04-165 T/487
Secondary ID HARECCTR0500038
Status Completed
Phase N/A
First received November 21, 2007
Last updated June 14, 2011
Start date April 2005
Est. completion date March 2007

Study information
Verified date June 2011
Source Hospital Authority, Hong Kong
Contact n/a
Is FDA regulated No
Health authority Hong Kong: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date March 2007
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Confirmed BOS post BMT

- Informed consent

Exclusion Criteria:

- Women currently pregnant or nursing

- Allergy to macrolide

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Azithromycin

• Placebo tablet

Locations
Country Name City State
China Queen Mary Hospital Hong Kong

Sponsors (3)
Lead Sponsor Collaborator
Hospital Authority, Hong Kong Pfizer, The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Quality of life assessment by questionnaires 3 months after treatment
Primary Spirometry 3 months after treatment
See also
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Recruiting NCT04098445 - TRANSPIRE: Lung Injury in a Longitudinal Cohort of Pediatric HSCT Patients
Completed NCT02441413 - Transplant Optimization Using Functional Imaging (TROFI) N/A
Recruiting NCT02543073 - MSC for Treatment of Interstitial Lung Disease After Allo-HSCT Phase 1/Phase 2
Terminated NCT01432080 - Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post Allotransplant Phase 2
Recruiting NCT00163696 - Multi Breath Nitrogen Washout (MBNW) as a Measure of Small Airway Function in Patients With Respiratory Disease N/A
Completed NCT00029328 - Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation Phase 1/Phase 2
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Completed NCT01211509 - Montelukast in Bronchiolitis Obliterans Syndrome Phase 4
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Completed NCT00141726 - Study of Enbrel (Etanercept) for the Treatment Sub-Acute Pulmonary Dysfunction After Allogeneic Stem Cell Transplant Phase 2
Recruiting NCT05922761 - BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP) Phase 2
Recruiting NCT05881538 - High Intensity Intervallic Training in Children With Bronchiolitis Obliterans N/A
Terminated NCT04655508 - Efficacy of Fluticasone Propionate Associated With Salmeterol Using Inhalation Chamber Versus Placebo to Improve the Respiratory Function in Children Over Six Years of Age Who Underwent Allogeneic Hematopoietic Stem Cell Transplantation With a Decline of FEV1 ≥10% From Pre Transplantation Phase 3
Withdrawn NCT02109237 - Sleep Disorders in Bronchiolitis Obliterans Syndrome 2&3 N/A
Completed NCT01327248 - Clinical Status and Bronchial Inflammation in Patients With Bronchiolitis Obliterans N/A
Recruiting NCT05932316 - Evaluating Bronchodilator Response in Patients With Bronchiectasis N/A
Active, not recruiting NCT03656926 - Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Single Lung Transplant (BOSTON-2) Phase 3

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