Time-Effect of Montelukast Protection

Asthma Clinical Trial

— TEMPE  

Official title:

Time-Effect of Montelukast on Protection Against Exercise-Induced Bronchoconstriction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00935415
• Other study ID #: PPDD1962
• Status: Completed
• Phase: Phase 4
• First received: July 7, 2009
• Last updated: July 8, 2009
• Start date: January 2007
• Est. completion date: August 2008

Study information

• Verified date: July 2009
• Source: Universita di Verona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 14 Years

Eligibility

Inclusion Criteria:

• children with exercise-induced asthma

Exclusion Criteria:

• viral infections

• montelukast treatment

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Asthma, Exercise-Induced
• Exercise-Induced Asthma

Intervention

Drug:
• Montelukast
Montelukast 5 mg
• Placebo
capsules of matching placebo

Locations

Country	Name	City	State
Italy	Pediatric Dept Hospital of Bolzano	Bolzano

Sponsors (1)

Lead Sponsor	Collaborator
Universita di Verona

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximal percentage fall in FEV1 after exercise test from the baseline value		at the first and at the third day of single day drug administration	No
Secondary	clinical protection		at the first and at the third day of single day drug administration	No