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CompletedNCT00563251Updated Jun 16, 2011

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

An interventional study of Azithromycin and Placebo tablet in Bronchiolitis Obliterans and Bone Marrow Transplantation, sponsored by Hospital Authority, Hong Kong. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-06-16.

Sponsored by Hospital Authority, Hong Kong · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Bronchiolitis Obliterans
  • Bone Marrow Transplantation

Keywords

  • Bronchiolitis obliterans in bone marrow transplant recipients
03

In context

Bronchiolitis Obliterans

89 studies on the registry are indexed under Bronchiolitis Obliterans; 11 are open to participants now.

This study's planned enrollment of 30 is close to the median of 30 across 61 interventional studies indexed under Bronchiolitis Obliterans.

Browse Bronchiolitis Obliterans studies →

Lead sponsor

Hospital Authority, Hong Kong is the lead sponsor of 79 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Confirmed BOS post BMT
  • Informed consent

Exclusion criteria

Exclusion Criteria:

  • Women currently pregnant or nursing
  • Allergy to macrolide
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
30 participants (estimated)

Interventions

06

What researchers measure

Primary outcomes

  1. Quality of life assessment by questionnaires

    Time frame: 3 months after treatment

  2. Spirometry

    Time frame: 3 months after treatment

07

Study locations

1 site
  • Queen Mary Hospital
    Hong Kong, China
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2005 and a completion of Mar 2007. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 21, 2007
First posted
Nov 26, 2007
Start
Apr 2005
CompletionActual
Mar 2007
Last update
Jun 16, 2011
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 16, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00563251
Lead sponsor
Hospital Authority, Hong Kong
First posted
Nov 26, 2007
Start date
Apr 2005
Completion
Mar 2007
Last update
Jun 16, 2011

Study contacts

Albert Lie, Dr
principal investigator · Department of Medicine, Queen Mary Hospital/ The University of Hong Kong
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Azithromycin

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