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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00935415 |
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Date of registration:
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07/07/2009 |
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Primary sponsor: |
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Public title:
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Time-Effect of Montelukast Protection
TEMPE |
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Scientific title:
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Time-Effect of Montelukast on Protection Against Exercise-Induced Bronchoconstriction |
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Date of first enrolment:
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January 2007 |
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Target sample size:
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69 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00935415 |
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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: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Italy
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Contacts
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Name:
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Attilio Boner, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universita di Verona |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- children with exercise-induced asthma
Exclusion Criteria:
- viral infections
- montelukast treatment
Age minimum:
6 Years
Age maximum:
14 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Asthma
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Exercise-Induced Asthma
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Intervention(s)
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Drug: Montelukast
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Drug: Placebo
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Primary Outcome(s)
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maximal percentage fall in FEV1 after exercise test from the baseline value
[Time Frame: at the first and at the third day of single day drug administration]
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Secondary Outcome(s)
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clinical protection
[Time Frame: at the first and at the third day of single day drug administration]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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