NCT00196547

Brief Summary

The purpose of the study is to determine if Montelukast added to other therapy, if any, will reduce the severity of asthma symptoms in children during the high incidence of respiratory viral infections that occur in children in the post Labor Day school return period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P50-P75 for phase_4 asthma

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_4 asthma

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
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

March 16, 2012

Status Verified

March 1, 2012

First QC Date

September 12, 2005

Last Update Submit

March 15, 2012

Conditions

Asthma

Keywords

AsthmaRespiratory viral infectionsExacerbationsPediatricLeukotriene receptor antagonistsSchool

Outcome Measures

Primary Outcomes (1)

  • Daily asthma symptom score

Secondary Outcomes (2)

  • Unscheduled physician visits (including ER)

  • Oral-cortico-steroid use

Interventions

Montelukast (drug)DRUG

Eligibility Criteria

Age2 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 2-14 years inclusive
  • Doctor-diagnosed asthma
  • Needing a beta-agonist inhaler at least once weekly on average for symptom relief
  • At least one day lost from school in the past year, or significantly limited activity, because of asthma
  • A history of asthma exacerbations associated with apparent respiratory viral infections
  • Parent or guardian who is willing to provide informed consent
  • Willing to give assent

You may not qualify if:

  • Non-English speaking
  • Unable to understand purpose of study and give consent
  • Concomitant respiratory or other major illness e.g. cystic fibrosis, cardiac disease
  • Currently using montelukast or other leukotriene receptor antagonist
  • Using regular oral corticosteroid
  • An asthma exacerbation requiring medical intervention during August 2005

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Firestone Institute for Respiratory Health

Hamilton, Ontario, L8N 4A6, Canada

Location

Related Publications (3)

  • Johnston NW, Johnston SL, Duncan JM, Greene JM, Kebadze T, Keith PK, Roy M, Waserman S, Sears MR. The September epidemic of asthma exacerbations in children: a search for etiology. J Allergy Clin Immunol. 2005 Jan;115(1):132-8. doi: 10.1016/j.jaci.2004.09.025.

    PMID: 15637559BACKGROUND

  • Bisgaard H, Zielen S, Garcia-Garcia ML, Johnston SL, Gilles L, Menten J, Tozzi CA, Polos P. Montelukast reduces asthma exacerbations in 2- to 5-year-old children with intermittent asthma. Am J Respir Crit Care Med. 2005 Feb 15;171(4):315-22. doi: 10.1164/rccm.200407-894OC. Epub 2004 Nov 12.

    PMID: 15542792BACKGROUND

  • Johnston NW, Mandhane PJ, Dai J, Duncan JM, Greene JM, Lambert K, Sears MR. Attenuation of the September epidemic of asthma exacerbations in children: a randomized, controlled trial of montelukast added to usual therapy. Pediatrics. 2007 Sep;120(3):e702-12. doi: 10.1542/peds.2006-3317.

    PMID: 17766511DERIVED

MeSH Terms

Conditions

Asthma

Interventions

montelukastPharmaceutical Preparations

Condition Hierarchy (Ancestors)

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

Study Officials

  • Malcolm R Sears, MB. ChB

    Firestone Institute for Respiratory Health, St. Joseph's Healthcare, Hamilton

    PRINCIPAL INVESTIGATOR

  • Neil W Johnston, MSc

    Firestone Institute for Respiratory Health, St. Joseph's Healthcare, Hamilton

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

September 1, 2005

Study Completion

November 1, 2005

Last Updated

March 16, 2012

Record last verified: 2012-03

Locations

CA(1)