NCT00140881

Brief Summary

A 53-week study to determine the effect of montelukast sodium when given to children (with infrequent episodic asthma) at the earliest symptoms of an acute episode of asthma.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P50-P75 for phase_4 asthma

Timeline
Completed

Started Jun 2000

Typical duration for phase_4 asthma

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

June 1, 2000

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2005

Completed
Last Updated

August 14, 2024

Status Verified

February 1, 2022

Enrollment Period

2.7 years

First QC Date

August 30, 2005

Last Update Submit

August 12, 2024

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Composite unscheduled acute health care resource utilisation (specific for asthma; unscheduled visits, GP attendance, ED attendance and hospital admission).

Secondary Outcomes (3)

  • Parent/caregiver QOL endpoints.

  • The safety and tolerability of montelukast when use as an episode modifier.

  • The duration and severity of the episode assessed by the parent/caregiver symptom score and the use of b-agonist and oral corticosteroid.

Interventions

MK0476; montelukast sodiumDRUG
Comparator: placeboDRUG

Eligibility Criteria

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

You may qualify if:

  • Males or females between the ages of 2 and 14 who have infrequent episodic asthma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Robertson CF, Price D, Henry R, Mellis C, Glasgow N, Fitzgerald D, Lee AJ, Turner J, Sant M. Short-course montelukast for intermittent asthma in children: a randomized controlled trial. Am J Respir Crit Care Med. 2007 Feb 15;175(4):323-9. doi: 10.1164/rccm.200510-1546OC. Epub 2006 Nov 16.

    PMID: 17110643BACKGROUND

MeSH Terms

Conditions

Asthma

Interventions

montelukast

Condition Hierarchy (Ancestors)

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

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2005

First Posted

September 1, 2005

Study Start

June 1, 2000

Primary Completion

February 14, 2003

Study Completion

February 14, 2003

Last Updated

August 14, 2024

Record last verified: 2022-02