Clinical Trial: Time-Effect of Montelukast Protection

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Summary: 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.
Sponsor: Universita di Verona

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: clinical protection [ Time Frame: at the first and at the third day of single day drug administration ]

Original Secondary Outcome: Same as current

Information By: Universita di Verona

Dates:
Date Received: July 7, 2009
Date Started: January 2007
Date Completion:
Last Updated: July 8, 2009
Last Verified: July 2009