Time-Effect of Montelukast Protection (TEMPE)

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

Condition Intervention Phase
Exercise-Induced Asthma
Drug: Montelukast
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Time-Effect of Montelukast on Protection Against Exercise-Induced Bronchoconstriction

Resource links provided by NLM:

Further study details as provided by Universita di Verona:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • clinical protection [ Time Frame: at the first and at the third day of single day drug administration ] [ Designated as safety issue: No ]

Enrollment: 69
Study Start Date: January 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Montelukast
capsules prepared in blindness
Drug: Montelukast
Montelukast 5 mg
Other Name: Singulair
Placebo Comparator: Placebo
matched placebo
Drug: Placebo
capsules of matching placebo

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.

Ages Eligible for Study:   6 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • children with exercise-induced asthma

Exclusion Criteria:

  • viral infections
  • montelukast treatment
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00935415

Pediatric Dept Hospital of Bolzano
Bolzano, Italy
Sponsors and Collaborators
Universita di Verona
Principal Investigator: Attilio Boner, MD Universita di Verona
  More Information

Responsible Party: Attilio Boner, Universita di Verona
ClinicalTrials.gov Identifier: NCT00935415     History of Changes
Other Study ID Numbers: PPDD1962 
Study First Received: July 7, 2009
Last Updated: July 8, 2009
Health Authority: Italy: Ethics Committee

Keywords provided by Universita di Verona:
exercise-induced bronchoconstriction
clinical protection
time effect

Additional relevant MeSH terms:
Asthma, Exercise-Induced
Bronchial Diseases
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Anti-Asthmatic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 03, 2016