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

A Multicenter, Double-Blind, Randomized, Parallel-Group Study Comparing Montelukast With Placebo in Pediatric Patients Aged 6 to 24 Months With Asthma

A study of Montelukast compared to placebo in asthmatic children aged 6-24 months.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: montelukast sodium; Drug: Comparator: Placebo

• Study Type: Interventional
• Enrollment (Actual): 256
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient is in good, stable health
• Patient has been fed solid foods for at least 1 month
• Patients had at least 3 episodes of asthma or asthma-like symptoms, all occurring after 8 weeks of age; at least one within 6 months of the Prestudy Visit
• Patients had to be in need of a controller therapy according to criteria established in the Global Initiative for Asthma (GINA) guidelines

Exclusion Criteria:

• Patient was hospitalized at the start of the study or required a visit to the emergency room due to asthma with in past 2 weeks

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2; Placebo	Drug: Comparator: Placebo; Placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks
Experimental: 1; Montelukast	Drug: montelukast sodium; Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Clinical Adverse Experiences (CAEs) Reported by Patients During the 6-weeks of Treatment	An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product	During the 6 weeks of treatment

Collaborators and Investigators

• Sponsor: Organon and Co

Publications and helpful links

General Publications

• van Adelsberg J, Moy J, Wei LX, Tozzi CA, Knorr B, Reiss TF. Safety, tolerability, and exploratory efficacy of montelukast in 6- to 24-month-old patients with asthma. Curr Med Res Opin. 2005 Jun;21(6):971-9. doi: 10.1185/030079905X48456.

Study record dates

Study Major Dates

• Study Start: August 1, 2000
• Primary Completion (Actual): February 1, 2001
• Study Completion (Actual): February 1, 2001

Study Registration Dates

• First Submitted: July 21, 2009
• First Submitted That Met QC Criteria: July 21, 2009
• First Posted (Estimate): July 22, 2009

Study Record Updates

• Last Update Posted (Actual): February 3, 2022
• Last Update Submitted That Met QC Criteria: February 1, 2022
• Last Verified: February 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; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Leukotriene Antagonists; Hormone Antagonists; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Montelukast
• Other Study ID Numbers: 0476-176; MK0476-176; 2009_618