NCT00337675

Brief Summary

This is a year-long study evaluating the efficacy of both daily and intermittent treatment of asthma in children who experience symptoms episodically (i.e., seasonally, usually in the context of upper respiratory tract infection).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,771

participants targeted

Target at P75+ for phase_3 asthma

Timeline
Completed

Started Oct 2006

Typical duration for phase_3 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

First Submitted

Initial submission to the registry

June 14, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 16, 2006

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
8 months until next milestone

Results Posted

Study results publicly available

March 15, 2010

Completed
Last Updated

May 10, 2024

Status Verified

January 1, 2022

Enrollment Period

2.8 years

First QC Date

June 14, 2006

Results QC Date

February 19, 2010

Last Update Submit

May 7, 2024

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Number of Asthma Episodes Culminating in Asthma Attack Over the 1-year Treatment Period

    The rate per year of asthma episodes culminating in an asthma attack for each of the 3 treatment groups. Asthma attacks were defined as respiratory symptoms requiring healthcare resource utilization (HRU), which comprised unscheduled visits to a physician or emergency department, treatment with corticosteroids (oral, rectal, or inhaled), or hospitalization. Each day during an episode, the patient's legal guardian recorded all the HRU that was required specifically for breathing problems.

    1-year treatment period

Secondary Outcomes (2)

  • Daily Average of Wheeze and Difficulty Breathing in the 3 Days Prior to Start of an Asthma Attack Within an Asthma Episode

    1 Year

  • Daily Average of the Mean Symptom Scores (Wheeze, Difficulty Breathing, Interference With Activity, and Daytime Cough) Assessed Over the 12-day Treatment Period of Asthma Episodes

    1 Year

Study Arms (3)

Arm 1: drug + episodic supplemental placebo

ACTIVE COMPARATOR

Montelukast once a day (qd) + episode driven supplemental placebo qd for 12 days for a 52-wk treatment period

Drug: montelukast sodium

Arm 2: placebo comparator + episodic supplemental drug

ACTIVE COMPARATOR

Placebo qd + episode driven supplemental Montelukast qd for 12 days for a 52-wk treatment period

Drug: montelukast sodium

Arm 3: placebo comparator + episodic supplemental placebo

PLACEBO COMPARATOR

Placebo qd + episode driven supplemental placebo qd for 12 days for a 52-wk treatment period

Drug: Comparator: Placebo (unspecified)

Interventions

montelukast sodiumDRUG

Montelukast 4 mg (or 5 mg, depending on age of patient) qd + episode driven supplemental Pbo qd for 12 days for a 52-wk treatment period.

Also known as: MK0476, Singulair®
Arm 1: drug + episodic supplemental placebo
Comparator: Placebo (unspecified)DRUG

Placebo (Pbo) qd + episode driven supplemental Pbo for 12 days for a 52-wk treatment period.

Arm 3: placebo comparator + episodic supplemental placebo

Eligibility Criteria

Age6 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients aged 6 months to 5 years with episodic (periodic) asthma

You may not qualify if:

  • Patients who are not in otherwise good health
  • Patients who have persistent asthma (continual asthma symptoms)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Valovirta E, Boza ML, Robertson CF, Verbruggen N, Smugar SS, Nelsen LM, Knorr BA, Reiss TF, Philip G, Gurner DM. Intermittent or daily montelukast versus placebo for episodic asthma in children. Ann Allergy Asthma Immunol. 2011 Jun;106(6):518-26. doi: 10.1016/j.anai.2011.01.017. Epub 2011 Mar 4.

    PMID: 21624752RESULT

MeSH Terms

Conditions

Asthma

Interventions

montelukast

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp
1-800-672-6372

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2006

First Posted

June 16, 2006

Study Start

October 1, 2006

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

May 10, 2024

Results First Posted

March 15, 2010

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share