NCT00213252

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

May 13, 2014

Status Verified

May 1, 2014

Enrollment Period

2.4 years

First QC Date

September 13, 2005

Last Update Submit

May 12, 2014

Conditions

Asthma, Bronchial

Keywords

asthma, randomized trial, pediatrics

Outcome Measures

Primary Outcomes (1)

  • Therapeutic failure rate

    From randomization at discharge from the Emergency Department to day 8

Secondary Outcomes (7)

  • Number of inhaled salbutamol treatments

    From randomization to 24, 48, 72, 96, 120, 144 hours and day 8

  • Change in the daytime asthma symptom scale from randomization

    48 hours and Day 8

  • Change in the nighttime cough

    8 days

  • Number of days without asthma

    8 days

  • Change in the Pulmonary Index Score from baseline

    48 hours and Day 8

  • +2 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL
Drug: Montelukast plus prednisolone

2

ACTIVE COMPARATOR
Drug: Prednisolone

Interventions

Montelukast plus prednisoloneDRUG

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

1
PrednisoloneDRUG

Six daily doses of oral prednisolone

2

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

  • Schuh S, Willan AR, Stephens D, Dick PT, Coates A. Can montelukast shorten prednisolone therapy in children with mild to moderate acute asthma? A randomized controlled trial. J Pediatr. 2009 Dec;155(6):795-800. doi: 10.1016/j.jpeds.2009.06.008. Epub 2009 Aug 4.

    PMID: 19656525RESULT

MeSH Terms

Conditions

Asthma

Interventions

montelukastPrednisolone

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Suzanne Schuh, MD

    The Hospital for Sick Children, Toronto, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

September 1, 2005

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

May 13, 2014

Record last verified: 2014-05

Locations

CA(1)