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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 March 2015 |
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Main ID: |
NCT01211509 |
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Date of registration:
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28/09/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Montelukast in Bronchiolitis Obliterans Syndrome
MLK002 |
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Scientific title:
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A Randomized, Double Blind, Placebo Controlled Trial With Montelukast to Treat Bronchiolitis Obliterans Syndrome After Lung Transplantation |
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Date of first enrolment:
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October 2010 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01211509 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Belgium
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Contacts
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Name:
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Geert M Verleden, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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UZ gasthuisberg |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of fBOS
- Signed informed consent
- Age at least 18 years old at moment of transplantation
- Able to take oral medication
Exclusion Criteria:
- Retransplantation
- Previous organ transplantation
- Multi organ transplantation
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Graft Rejection
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Bronchiolitis Obliterans
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Lung Transplantation
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Intervention(s)
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Drug: Montelukast
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Primary Outcome(s)
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survival/retransplantation rate after diagnosis of BOS
[Time Frame: 1 year after diagnosis]
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survival/retransplantation rate at 2 years after diagnosis
[Time Frame: 2 years after diagnosis]
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Secondary Outcome(s)
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Bronchoalveolar lavage fluid (BAL)
[Time Frame: during 1 and 2 years of treatment]
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peripheral blood
[Time Frame: during 1 and 2 years of treatment]
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Cytomegalovirus (CMV) and non-CMV infection rates
[Time Frame: during 1 and 2 years of follow up]
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Acute rejection and lymphocytic bronchiolitis rates
[Time Frame: after 1 and 2 years of treatment]
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Obstructive and restrictive pulmonary function evolution
[Time Frame: during 1 and 2 years of treatment]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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