Ignite Creation Date:
2024-05-05 @ 9:39 PM
Last Modification Date:
2024-10-26 @ 10:07 AM
Study NCT ID:
NCT00935415
Status:
COMPLETED
Last Update Posted:
2009-07-09
First Post:
2009-07-07
Brief Title:
Time-Effect of Montelukast Protection
Sponsor:
Universita di Verona
Organization:
Universita di Verona
Study Overview
Official Title:
Time-Effect of Montelukast on Protection Against Exercise-Induced Bronchoconstriction
Status:
COMPLETED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TEMPE
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 800 AM 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None