A Study of Montelukast (MK-0476) Compared With Fluticasone in Pediatric Participants With Chronic Asthma (MK-0476-303)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Evaluate MK0476 and Fluticasone to Control Asthma in Patients With Mild Persistent Asthma (0476-910)

NCT00489346

Asthma, Bronchial

COMPLETED PHASE3

Montelukast in Pediatric Allergic Asthma (0476-336)(COMPLETED)

NCT00289874

Asthma

COMPLETED PHASE3

A Study to Determine the Effect of Montelukast Sodium as an Episode Modifier in the Treatment of Infrequent Episodic Asthma in Children (0476-165)

NCT00140881

Asthma

COMPLETED PHASE4

Montelukast in Pediatric Patients Aged 6 to 24 Months With Asthma--Safety Study (0476-176)

NCT00943683

Asthma

COMPLETED NA

PK Study in 3- to 6- Month-Old Children (0476-268)(COMPLETED)

NCT00394069

Bronchiolitis

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study consists of a 4-week placebo run-in period followed by a 24-week double-blind treatment period.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma, Bronchial

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Montelukast

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.

Group Type EXPERIMENTAL

Montelukast sodium

Intervention Type DRUG

Montelukast 4 mg OG or montelukast 4 mg CT

Placebo to fluticasone

Intervention Type DRUG

Placebo inhalation aerosol metered dose inhaler

Fluticasone

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.

Group Type ACTIVE_COMPARATOR

Placebo to montelukast

Intervention Type DRUG

Placebo OG or CT

Fluticasone propionate

Intervention Type DRUG

Fluticasone 50 mcg inhalation aerosol metered dose inhaler

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Montelukast sodium

Montelukast 4 mg OG or montelukast 4 mg CT

Intervention Type DRUG

Placebo to montelukast

Placebo OG or CT

Intervention Type DRUG

Fluticasone propionate

Fluticasone 50 mcg inhalation aerosol metered dose inhaler

Intervention Type DRUG

Placebo to fluticasone

Placebo inhalation aerosol metered dose inhaler

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MK-0476 Singulair®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

6 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No