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OpenTrials
Completed

NCT Number: NCT00563251

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Mary Hospital

Hong Kong, China

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed BOS post BMT
  • Informed consent

Exclusion criteria

  • Women currently pregnant or nursing
  • Allergy to macrolide

Treatment and study plan

Azithromycin

Drug

Placebo Tablet

Drug

Primary outcomes

  1. Quality of life assessment by questionnaires

    Time frame: 3 months after treatment

  2. Spirometry

    Time frame: 3 months after treatment

Sponsors and collaborators

Lead sponsor

Hospital Authority, Hong Kong

Other Gov

Collaborators

  • Pfizer
  • The University of Hong Kong

Registry information

Official study title

Azithromycin Therapy for Bronchiolitis Obliterans Syndrome After Allogenic Bone Marrow Transplantation

Important dates

Study start
2005
Study completion
2007
First posted
Nov 26, 2007
Registry last updated
Jun 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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