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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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12 December 2020 |
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Main ID: |
NCT03133299 |
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Date of registration:
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21/04/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study Evaluating Vitamin D in Allergic Bronchopulmonary Aspergillosis Complicating Asthma
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Scientific title:
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A Study Evaluating Vitamin D in Allergic Bronchopulmonary Aspergillosis Complicating Asthma |
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Date of first enrolment:
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December 1, 2016 |
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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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https://clinicaltrials.gov/show/NCT03133299 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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India
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of ABPA as per the International Society for Human and Animal Mycology
Working group criteria
- Treatment naïve
Exclusion Criteria:
- Failure to provide informed consent
- Enrollment in another trial of ABPA
- Pregnancy
- Creatinine more than or equal to 1.5 mg/dL
- Immunosuppressive states like chronic liver disease, chronic renal failure, cytotoxic
therapy, uncontrolled diabetes mellitus and others
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Allergic Bronchopulmonary Aspergilloses
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Intervention(s)
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Drug: Glucocorticoids
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Drug: Vitamin D
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Primary Outcome(s)
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Decline in total IgE
[Time Frame: Two months]
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Secondary Outcome(s)
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Th1/Th2 cytokines
[Time Frame: Two months]
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Decline in total IgE
[Time Frame: Four months]
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Time to first exacerbation
[Time Frame: One year]
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Th1/Th2 cytokines
[Time Frame: Four months]
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Decline in total IgE
[Time Frame: Six months]
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Th1/Th2 cytokines
[Time Frame: Six months]
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Secondary ID(s)
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Pulm.Med/2017/002
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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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