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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Montelukast | Active Comparator | capsules prepared in blindness |
|
| Placebo | Placebo Comparator | matched placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Montelukast | Drug | Montelukast 5 mg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| clinical protection | at the first and at the third day of single day drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Attilio Boner, MD | Universita di Verona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Dept Hospital of Bolzano | Bolzano | Italy |
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| ID | Term |
|---|---|
| D001250 | Asthma, Exercise-Induced |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D000092202 | Exercise-Induced Allergies |
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| ID | Term |
|---|---|
| C093875 | montelukast |
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| Placebo | Drug | capsules of matching placebo |
|
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |