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

A Phase III Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Prospectively Evaluate Efficacy of Montelukast in Patients Aged 6 Months to 5 Years With Chronic Asthma

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.

Study Overview

• Status: Withdrawn
• Conditions: Asthma, Bronchial
• Intervention / Treatment: Drug: Montelukast sodium; Drug: Placebo to fluticasone; Drug: Placebo to montelukast; Drug: Fluticasone propionate

Detailed Description

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

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Montelukast sodium; Montelukast 4 mg OG or montelukast 4 mg CT; Other Names: MK-0476; Singulair®; Drug: Placebo to fluticasone; Placebo inhalation aerosol metered dose inhaler
Active Comparator: 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.	Drug: Placebo to montelukast; Placebo OG or CT; Drug: Fluticasone propionate; Fluticasone 50 mcg inhalation aerosol metered dose inhaler

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Percentage of participants without asthma attacks	24 weeks
Percentage of participants without corticosteroid rescues	24 weeks
Caregiver global evaluation	Week 24
Physician global evaluation	Week 24
Percentage of days without individual daytime asthma symptoms (cough, wheeze, trouble breathing, and activity limitation)	24 weeks

Collaborators and Investigators

• Sponsor: Organon and Co

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): March 1, 2008
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: October 4, 2007
• First Submitted That Met QC Criteria: October 4, 2007
• First Posted (Estimate): October 8, 2007

Study Record Updates

• Last Update Posted (Actual): February 14, 2022
• Last Update Submitted That Met QC Criteria: January 31, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Leukotriene Antagonists; Hormone Antagonists; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Anti-Allergic Agents; Montelukast; Fluticasone; Xhance
• Other Study ID Numbers: 0476-303; 2007_583 (Other Identifier: Telerx ID Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No