Bronchiolitis ObliteransNCT00563251
Effectiveness of Azithromycin Therapy in Improvement of Symptoms and Lung Function in Patients With Bronchiolitis Obliterans After Bone Marrow Transplantation
A study testing Azithromycin in people with Bronchiolitis Obliterans and Bone Marrow Transplantation, run by Hospital Authority, Hong Kong at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiolitis Obliterans, Bone Marrow Transplantation
- What is being tested?
- Azithromycin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Apr 2005to Mar 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Confirmed BOS post BMT
- Informed consent
Who cannot join
- Women currently pregnant or nursing
- Allergy to macrolide
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Azithromycin Therapy for Bronchiolitis Obliterans Syndrome After Allogenic 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.
- Being tested
- Azithromycin, Placebo tablet
- Keywords
- Bronchiolitis obliterans in bone marrow transplant recipients
- Medical subject headings
- Bronchiolitis Obliterans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
Placebo tabletDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life assessment by questionnaires
Measured: 3 months after treatment
Spirometry
Measured: 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2007 (estimated)
- Study startApr 2005
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiolitis ObliteransStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Collaborators
- The University of Hong Kong, Pfizer
- Investigators
- Albert Lie, Dr, Principal investigator, Department of Medicine, Queen Mary Hospital/ The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00563251
- Sponsor's protocol ID
- UW 04-165 T/487
- Other IDs
- HARECCTR0500038
- Status last verified
- Jun 2011
- First submitted
- 21 Nov 2007
- Last updated
- 16 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Azithromycin Therapy for Bronchiolitis Obliterans Syndrome After Allogenic Bone Marrow Transplantation
- ClinicalTrials.gov ID
- NCT00563251
- Acronym / sponsor ID
- UW 04-165 T/487
- Keywords
- Bronchiolitis obliterans in bone marrow transplant recipients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Collaborators
- The University of Hong Kong, Pfizer
- Study start
- Apr 2005
- Study completion
- Mar 2007 (actual)
- First posted
- 26 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Confirmed BOS post BMT
- Informed consent
Key exclusion criteria (2 listed)
- Women currently pregnant or nursing
- Allergy to macrolide
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azithromycin | Drug | – |
| Placebo tablet | Drug | – |
Primary outcome
Quality of life assessment by questionnaires
Time frame: 3 months after treatment
Spirometry
Time frame: 3 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Albert Lie, Dr principal investigator
Department of Medicine, Queen Mary Hospital/ The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Azithromycin in people with Bronchiolitis Obliterans and Bone Marrow Transplantation, run by Hospital Authority, Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life assessment by questionnaires (time frame: 3 months after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2011.