- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00563251
Effectiveness of Azithromycin Therapy in Improvement of Symptoms and Lung Function in Patients With Bronchiolitis Obliterans After Bone Marrow Transplantation
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Hong Kong, China
- Queen Mary Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Confirmed BOS post BMT
- Informed consent
Exclusion Criteria:
- Women currently pregnant or nursing
- Allergy to macrolide
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quality of life assessment by questionnaires
Time Frame: 3 months after treatment
|
3 months after treatment
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Spirometry
Time Frame: 3 months after treatment
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3 months after treatment
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Albert Lie, Dr, Department of Medicine, Queen Mary Hospital/ The University of Hong Kong
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UW 04-165 T/487
- HARECCTR0500038
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bronchiolitis Obliterans
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Washington University School of MedicineThe Foundation for Barnes-Jewish Hospital; Mallinckrodt; Centers for Medicare...Active, not recruitingBronchiolitis Obliterans Syndrome (BOS)United States
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Renovion, Inc.RecruitingPre-Bronchiolitis Obliterans SyndromeUnited States
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Children's Hospital Medical Center, CincinnatiRecruitingBronchiolitis Obliterans (BO) | Hematopoietic Stem Cell Transplant (HSCT)United States
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University of ChicagoCompletedBronchiolitis Obliterans SyndromeUnited States
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Zambon SpATerminatedStem Cell Transplant Complications | GVHD, Chronic | Bronchiolitis Obliterans Syndrome (BOS)Spain, France, Germany
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University Hospital RegensburgClinAssess GmbHUnknownSteroid-refractory Bronchiolitis ObliteransGermany
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KU LeuvenUniversity Hospital, Gasthuisberg; Fund for Scientific Research, Flanders,...CompletedGraft Rejection | Respiratory Infection | Bronchiolitis Obliterans Syndrome | Lymphocytic BronchiolitisBelgium
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Hopital FochCompletedBronchiolitis Obliterans SyndromeFrance
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Zambon SpAEnrolling by invitationBronchiolitis Obliterans | Bronchiolitis Obliterans Syndrome | Obliterative BronchiolitisFrance, United States, Spain, Israel, Belgium, Denmark, Germany, United Kingdom, Austria
Clinical Trials on Azithromycin
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PfizerCompletedTonsillitis | PharyngitisBelgium, India, Germany, United States, France, United Kingdom, Netherlands, Finland, Italy, Norway
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Sheba Medical CenterUnknown
-
PfizerCompletedBacterial Infections
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Thomas Jefferson UniversityChristiana Care Health ServicesCompletedPreterm Premature Rupture of MembraneUnited States
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GlaxoSmithKlineCompletedAutoimmune DiseasesUnited Kingdom
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Emory UniversityThe Carter CenterSuspended
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University of Alabama at BirminghamMerck Sharp & Dohme LLCCompletedPostpartum Sepsis | Postpartum Endometritis | Postpartum FeverCameroon
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University of Alabama at BirminghamCompletedRespiratory Syncytial VirusUnited States