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Time-Effect of Montelukast Protection (TEMPE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00935415
Recruitment Status : Completed
First Posted : July 9, 2009
Last Update Posted : July 9, 2009
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Exercise-Induced Asthma Asthma Drug: Montelukast Drug: Placebo Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Time-Effect of Montelukast on Protection Against Exercise-Induced Bronchoconstriction
Study Start Date : January 2007
Primary Completion Date : August 2008
Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Montelukast
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. clinical protection [ Time Frame: at the first and at the third day of single day drug administration ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children with exercise-induced asthma

Exclusion Criteria:

  • viral infections
  • montelukast treatment
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00935415


Locations
Italy
Pediatric Dept Hospital of Bolzano
Bolzano, Italy
Sponsors and Collaborators
Universita di Verona
Investigators
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
First Posted: July 9, 2009    Key Record Dates
Last Update Posted: July 9, 2009
Last Verified: July 2009

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

Additional relevant MeSH terms:
Asthma, Exercise-Induced
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Montelukast
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action