Time-Effect of Montelukast Protection
Overview[ - collapse ][ - ]
Purpose | The aim of this study is to verify MNT time of onset of protection against EIB in asthmatic children by evaluating different time intervals between dosing and challenge, after a single-dose and after three days of once a day MNT administration. |
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Condition | Exercise-Induced Asthma Asthma |
Intervention | Drug: Montelukast Drug: Placebo |
Phase | Phase 4 |
Sponsor | Universita di Verona |
Responsible Party | Universita di Verona |
ClinicalTrials.gov Identifier | NCT00935415 |
First Received | July 7, 2009 |
Last Updated | July 8, 2009 |
Last verified | July 2009 |
Tracking Information[ + expand ][ + ]
First Received Date | July 7, 2009 |
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Last Updated Date | July 8, 2009 |
Start Date | January 2007 |
Estimated Primary Completion Date | August 2008 |
Current Primary Outcome Measures | 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] [Designated as safety issue: No] |
Current Secondary Outcome Measures | clinical protection [Time Frame: at the first and at the third day of single day drug administration] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
Brief Title | Time-Effect of Montelukast Protection |
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Official Title | Time-Effect of Montelukast on Protection Against Exercise-Induced Bronchoconstriction |
Brief Summary | The aim of this study is to verify MNT time of onset of protection against EIB in asthmatic children by evaluating different time intervals between dosing and challenge, after a single-dose and after three days of once a day MNT administration. |
Detailed Description | Within few days after a baseline exercise challenge, children was randomized to a double blind, placebo-controlled, three day doses, crossover study design. In practice each eligible patient was randomized by a computer-generated schedule to receive in sequence double-blind treatments with placebo or MNT (5 mg). Patients in sequence 1 received MNT, then crossed over to matching placebo; vice versa the case was for patients in sequence 2. Placebo and active treatments were separated by a 7-10 day wash-out period. Each child was assigned to one out of seven groups in order to perform the exercise challenge at different time intervals from drug administration which occurred always at 8.00 A.M. On day one the challenge was performed in the different groups 1, 2, 3, 4, 5, 6, and 8 hours after drug administration, respectively. Then treatment was continued as a single day dose for three consecutive days and a third challenge was then performed at the same time of the day. |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
Condition |
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Intervention | Drug: Montelukast Montelukast 5 mg Other Names: SingulairDrug: Placebo capsules of matching placebo |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 69 |
Estimated Completion Date | August 2008 |
Estimated Primary Completion Date | August 2008 |
Eligibility Criteria | Inclusion Criteria: - children with exercise-induced asthma Exclusion Criteria: - viral infections - montelukast treatment |
Gender | Both |
Ages | 6 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Italy |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00935415 |
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Other Study ID Numbers | PPDD1962 |
Has Data Monitoring Committee | No |
Information Provided By | Universita di Verona |
Study Sponsor | Universita di Verona |
Collaborators | Not Provided |
Investigators | Principal Investigator: Attilio Boner, MD Universita di Verona |
Verification Date | July 2009 |
Locations[ + expand ][ + ]
Pediatric Dept Hospital of Bolzano | Bolzano, Italy |
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