A Phase 4 interventional study of Montelukast and Placebo in Exercise-Induced Asthma and Asthma, sponsored by Universita di Verona. Completed at 1 site in Italy. Open to participants aged 6 Years to 14 Years. Per ClinicalTrials.gov, last updated 2009-07-09.
Sponsored by Universita di Verona · Phase 4, Interventional, and Treatment
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.
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.
52 studies on the registry are indexed under Asthma, Exercise-Induced; 3 are open to participants now.
This study's enrollment of 69 is above the median of 47 across 40 interventional studies indexed under Asthma, Exercise-Induced.
Browse Asthma, Exercise-Induced studies →Universita di Verona is the lead sponsor of 125 studies on the registry; 27 are open to participants now.
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Exclusion Criteria:
capsules prepared in blindness
Drug: Montelukast
matched placebo
Drug: Placebo
Montelukast 5 mg
Also known as: Singulair
capsules of matching placebo
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
clinical protection
Time frame: at the first and at the third day of single day drug administration
This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Montelukast