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

May 12, 2014 updated by: Suzanne Schuh, The Hospital for Sick Children

Can Montelukast Shorten Corticosteroid Therapy In Children With Mild To Moderate Acute Asthma?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We plan a randomized double blind double-dummy trial of 190 previously healthy children 2-17 years of age presenting to the Emergency Department (ED) at the Hospital for Sick Children in Toronto with mild to moderate acute asthma, with the Pulmonary Index score ≤ 11 points and PRAM ≤ 8 points. Asthma will be defined as at least the second episode of wheezing, with signs of lower airway obstruction. All participating children will receive a single dose of oral prednisolone 2mg/kg (max 60 mg) on arrival and standardized inhaled salbutamol in the ED and for five days thereafter. At discharge from ED children will be randomized to two interventional groups. Those in the Montelukast group will get oral Montelukast 4 mg (2-5 year olds), 5 mg (6-14 year olds), and 10 mg (15-17 year olds) as well as daily prednis(ol)one placebo 24 hours after the ED dose of prednisolone and at 48, 72, 96 and 120 hours, while those in the prednisolone group will receive Montelukast placebo and daily oral prednisolone 1mg/kg (max 60 mg) for five further doses at these times.

The primary outcome will be therapeutic failure in the two groups from randomization to day 8. This failure will be defined as unscheduled medical visits for asthma symptoms or hospitalization or treatment with oral corticosteroids outside the experimental protocol. Secondary outcome measures include comparison of the number of salbutamol treatments, changes in the previously validated daytime symptoms scale, nighttime cough/awakening scale, number of asthma-free days within the 8 day observational period in the two groups, changes in the PI and PRAM scores to 48 hours and day 8 as well as the association between the main treatment effect and age, pulmonary index at randomization and history of atopy.

This study will take two 9 months periods. Primary analysis will include a one-sided 95% CI for the difference in failure rate in the prednisolone group minus the Montelukast group. Secondary analyses will include repeated measures ANOVA for differences in changes of continuous variables and the Fisher's Exact test for comparison of proportions. An exploratory sub-group logistic regression analysis will be done for examining interaction between the main treatment effect and possible covariates.

In the event that the patients given a single dose of prednisolone followed by Montelukast have comparable therapeutic failure rate to those given standard extended prednisolone therapy, administration of Montelukast may help us abbreviate the length of corticosteroid therapy in children with acute asthma.

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • The Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age 2-17 years
  • Clinical diagnosis of mild to moderate asthma as a second wheezing episode associated with signs of respiratory distress suggesting lower airway obstruction such as tachypnea and/or use of accessory muscles of respiration.
  • baseline Pulmonary Index Clinical Score (Appendix B) ≤ 11 out of 15 possible points as well as PRAM ≤ 8 out of 12 points.
  • Presenting to the Sick Kids Emergency Department
  • Children capable of FEV1 measurement will have FEV1 more than 60% of the predicted value
  • male or female
  • Willing and able to provide informed consent (or informed consent by parents)

Exclusion Criteria:

  • No previous history of wheezing or bronchodilator therapy. This population may eventually have diagnoses other than asthma or viral induced wheezing
  • Patients who received more than a single dose of oral corticosteroids within 72 hours prior to arrival
  • Patients receiving more than 500 mcg per day of fluticasone for more than 1 month or more than 250 mcg of fluticasone for more than 7 days prior to arrival
  • Patients who have had more than 2 previous visits to the asthma clinic at SickKids
  • Patients who received Montelukast within one week of arrival
  • Critically ill patients requiring airway stabilization
  • Patients with severe asthma, defined as PI 12 to 15 or PRAM 9 to 12.
  • Co-existent co-morbidities such as chronic pulmonary disease and cardiac disease requiring pharmacotherapy, neurologic disease and immune disorders.
  • Previous admission to ICU for asthma.
  • More than 3 hospitalizations for asthma during the past 12 months.
  • Contact with varicella within the previous 21 days.
  • Insufficient command of the English language

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Montelukast plus prednisolone
Single dose of oral prednisolone with a subsequent daily five-day course of oral Montelukast
Active Comparator: 2
Drug: Prednisolone
Six daily doses of oral prednisolone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Therapeutic failure rate
Time Frame: From randomization at discharge from the Emergency Department to day 8
From randomization at discharge from the Emergency Department to day 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of inhaled salbutamol treatments
Time Frame: From randomization to 24, 48, 72, 96, 120, 144 hours and day 8
From randomization to 24, 48, 72, 96, 120, 144 hours and day 8
Change in the daytime asthma symptom scale from randomization
Time Frame: 48 hours and Day 8
48 hours and Day 8
Change in the nighttime cough
Time Frame: 8 days
8 days
Number of days without asthma
Time Frame: 8 days
8 days
Change in the Pulmonary Index Score from baseline
Time Frame: 48 hours and Day 8
48 hours and Day 8
Change in the Pediatric Respiratory Assessment Measure(PRAM)from baseline
Time Frame: 48 hours and Day 8
48 hours and Day 8
Association between the main treatment effect and patients' age, disease severity at randomization (Pulmonary Index and PRAM) and personal/family history of atopy.
Time Frame: 48 hours and Day 8
48 hours and Day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Collaborators

Merck Frosst Canada Ltd.

Investigators

  • Principal Investigator: Suzanne Schuh, MD, The Hospital for Sick Children, Toronto, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

May 13, 2014

Last Update Submitted That Met QC Criteria

May 12, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000007674

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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