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Use of Montelukast to Treat Children With Mild to Moderate Acute Asthma

NCT00213252 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2014-05-13

No results posted yet for this study

Summary

The primary objective of this study is to evaluate if children with acute asthma given a single dose of oral prednisolone with a subsequent daily five-day course of oral Montelukast will achieve a therapeutic failure rate at day 8 not significantly higher than those given six daily doses of oral prednisolone. Secondary objectives include comparison of the two groups with respect to the changes in symptoms, beta2 agonists, clinical asthma score and days without asthma by day 8.

Conditions

  • Asthma, Bronchial

Interventions

DRUG

Montelukast plus prednisolone

Single dose of oral prednisolone with a subsequent daily five-day course of oral Montelukast

DRUG

Prednisolone

Six daily doses of oral prednisolone

Sponsors & Collaborators

  • Merck Frosst Canada Ltd.

    collaborator INDUSTRY

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Suzanne Schuh, MD · The Hospital for Sick Children, Toronto, Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2008-02-29
Completion
2008-02-29

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00213252 on ClinicalTrials.gov