Time-Effect of Montelukast Protection

NCT ID: NCT00935415

Last Updated: 2009-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2008-08-31

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.

Conditions

Exercise-Induced Asthma; Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Montelukast

capsules prepared in blindness

Group Type: ACTIVE_COMPARATOR

Montelukast

Intervention Type: DRUG

Montelukast 5 mg

Placebo

matched placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

capsules of matching placebo

Interventions

Montelukast

Montelukast 5 mg

Intervention Type: DRUG

Placebo

capsules of matching placebo

Intervention Type: DRUG

Other Intervention Names

Singulair

Eligibility Criteria

Inclusion Criteria

• children with exercise-induced asthma

Exclusion Criteria

• viral infections
• montelukast treatment

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universita di Verona

OTHER

Sponsor Role: lead

Responsible Party

Universita di Verona

Principal Investigators

Attilio Boner, MD

Role: PRINCIPAL_INVESTIGATOR

Universita di Verona

Locations

Pediatric Dept Hospital of Bolzano

Bolzano, , Italy

Countries

Italy

Other Identifiers

PPDD1962

Identifier Type: -

Identifier Source: org_study_id