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Time-Effect of Montelukast Protection (TEMPE)

This study has been completed.
Sponsor:
Information provided by:
Universita di Verona
ClinicalTrials.gov Identifier:
NCT00935415
First received: July 7, 2009
Last updated: July 8, 2009
Last verified: July 2009

July 7, 2009
July 8, 2009
January 2007
August 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00935415 on ClinicalTrials.gov Archive Site
clinical protection [ Time Frame: at the first and at the third day of single day drug administration ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Time-Effect of Montelukast Protection
Time-Effect of Montelukast on Protection Against Exercise-Induced Bronchoconstriction

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Exercise-Induced Asthma
  • Asthma
  • Drug: Montelukast
    Montelukast 5 mg
    Other Name: Singulair
  • Drug: Placebo
    capsules of matching placebo
  • Active Comparator: Montelukast
    capsules prepared in blindness
    Intervention: Drug: Montelukast
  • Placebo Comparator: Placebo
    matched placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
69
August 2008
August 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • children with exercise-induced asthma

Exclusion Criteria:

  • viral infections
  • montelukast treatment
Both
6 Years to 14 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00935415
PPDD1962
No
Attilio Boner, Universita di Verona
Universita di Verona
Not Provided
Principal Investigator: Attilio Boner, MD Universita di Verona
Universita di Verona
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP