Time-Effect of Montelukast Protection
- Registration Number
- NCT00935415
- Lead Sponsor
- Universita di Verona
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 69
- children with exercise-induced asthma
- viral infections
- montelukast treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Placebo matched placebo Montelukast Montelukast capsules prepared in blindness
- Primary Outcome Measures
Name Time Method maximal percentage fall in FEV1 after exercise test from the baseline value at the first and at the third day of single day drug administration
- Secondary Outcome Measures
Name Time Method clinical protection at the first and at the third day of single day drug administration
Trial Locations
- Locations (1)
Pediatric Dept Hospital of Bolzano
🇮🇹Bolzano, Italy