Time-Effect of Montelukast Protection

Overview[ - collapse ][ - ]

Purpose 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.
ConditionExercise-Induced Asthma
Asthma
InterventionDrug: Montelukast
Drug: Placebo
PhasePhase 4
SponsorUniversita di Verona
Responsible PartyUniversita di Verona
ClinicalTrials.gov IdentifierNCT00935415
First ReceivedJuly 7, 2009
Last UpdatedJuly 8, 2009
Last verifiedJuly 2009

Tracking Information[ + expand ][ + ]

First Received DateJuly 7, 2009
Last Updated DateJuly 8, 2009
Start DateJanuary 2007
Estimated Primary Completion DateAugust 2008
Current Primary Outcome Measuresmaximal 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] [Designated as safety issue: No]
Current Secondary Outcome Measuresclinical protection [Time Frame: at the first and at the third day of single day drug administration] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleTime-Effect of Montelukast Protection
Official TitleTime-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 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.
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Condition
  • Exercise-Induced Asthma
  • Asthma
InterventionDrug: Montelukast
Montelukast 5 mg
Other Names:
SingulairDrug: Placebo
capsules of matching placebo
Study Arm (s)
  • Active Comparator: Montelukast
    capsules prepared in blindness
  • Placebo Comparator: Placebo
    matched placebo

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment69
Estimated Completion DateAugust 2008
Estimated Primary Completion DateAugust 2008
Eligibility Criteria
Inclusion Criteria:

- children with exercise-induced asthma

Exclusion Criteria:

- viral infections

- montelukast treatment
GenderBoth
Ages6 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesItaly

Administrative Information[ + expand ][ + ]

NCT Number NCT00935415
Other Study ID NumbersPPDD1962
Has Data Monitoring CommitteeNo
Information Provided ByUniversita di Verona
Study SponsorUniversita di Verona
CollaboratorsNot Provided
Investigators Principal Investigator: Attilio Boner, MD Universita di Verona
Verification DateJuly 2009

Locations[ + expand ][ + ]

Pediatric Dept Hospital of Bolzano
Bolzano, Italy