NCT00540839

Brief Summary

A study to determine the effects of montelukast (MK-0476) on pediatric participants with chronic asthma compared with fluticasone. The primary hypotheses are that, over 24 weeks of treatment, montelukast will provide at least the same level of asthma control as inhaled fluticasone as measured by the percentage of days without asthma and that, over 24 weeks of treatment, daily administration of montelukast will be safe and well tolerated in children aged 6 months to 5 years with chronic asthma. This trial was stopped at a time before any participants had actually entered the trial. Based on input from regulatory agencies, it is not necessary to conduct this study; a separate ongoing study was sufficient for regulatory purposes.

Trial Health

10
At Risk

Trial Health Score

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

Status
withdrawn

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Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 8, 2007

Completed
24 days until next milestone

Study Start

First participant enrolled

November 1, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Last Updated

February 14, 2022

Status Verified

January 1, 2022

Enrollment Period

4 months

First QC Date

October 4, 2007

Last Update Submit

January 31, 2022

Conditions

Asthma, Bronchial

Outcome Measures

Primary Outcomes (3)

  • Percentage of days without asthma

    A day without asthma is defined as a day with all of the following: no daytime symptoms, no nighttime cough, no β-agonist use, and no asthma attack (defined as a visit to a doctor, urgent care clinic, emergency room, or hospital for asthma \[other than a scheduled visit to a doctor\], or treatment with systemic corticosteroid during the previous 24 hours).

    24 weeks

  • Number of participants who experience at least one adverse event (AE)

    Up to 26 weeks

  • Number of participants who discontinue study drug due to an AE

    Up to 24 weeks

Secondary Outcomes (3)

  • Percentage of days without daytime symptoms

    24 weeks

  • Percentage of days without nighttime cough

    24 weeks

  • Percentage of days without β-agonist use

    24 weeks

Other Outcomes (5)

  • Percentage of participants without asthma attacks

    24 weeks

  • Percentage of participants without corticosteroid rescues

    24 weeks

  • Caregiver global evaluation

    Week 24

  • +2 more other outcomes

Study Arms (2)

Montelukast

EXPERIMENTAL

Participants receive montelukast 4 mg oral granules (OG) or 4 mg chewable tablets (CT) once daily (QD) for 24 weeks and placebo to fluticasone 50 mcg inhalation aerosol twice daily (BID) for 24 weeks. Participants aged \>6 months to \<2 years receive montelukast 4 mg packet of OG QD for 24 weeks. Participants aged \>2 years to \<64 months receive montelukast 4 mg CT QD for 24 weeks.

Drug: Montelukast sodiumDrug: Placebo to fluticasone

Fluticasone

ACTIVE COMPARATOR

Participants receive fluticasone 50 mcg inhalation aerosol twice daily (BID) for 24 weeks and placebo to montelukast 4 mg QD for 24 weeks. Participants aged \>6 months to \<2 years receive placebo packet of OG QD for 24 weeks. Participants aged \>2 years to \<64 months receive placebo CT QD for 24 weeks.

Drug: Placebo to montelukastDrug: Fluticasone propionate

Interventions

Montelukast sodiumDRUG

Montelukast 4 mg OG or montelukast 4 mg CT

Also known as: MK-0476, Singulair®
Montelukast
Placebo to montelukastDRUG

Placebo OG or CT

Fluticasone
Fluticasone propionateDRUG

Fluticasone 50 mcg inhalation aerosol metered dose inhaler

Fluticasone
Placebo to fluticasoneDRUG

Placebo inhalation aerosol metered dose inhaler

Montelukast

Eligibility Criteria

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

You may qualify if:

  • Between 6 months and 5 years, 4 months of age
  • Diagnosed with asthma by a doctor
  • At least 3 episodes of asthma symptoms within the last 6 months

You may not qualify if:

  • Active or chronic breathing disease, other than asthma
  • Required insertion of a breathing tube for asthma
  • Major surgery within the last 4 weeks
  • Currently in the hospital
  • Allergic to certain drugs, and for children under 2 years of age, apples, applesauce and formula

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Interventions

montelukastFluticasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

AndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Medical Director

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR
0

Study Design

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

Study Record Dates

First Submitted

October 4, 2007

First Posted

October 8, 2007

Study Start

November 1, 2007

Primary Completion

March 1, 2008

Last Updated

February 14, 2022

Record last verified: 2022-01