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

A Multicenter, Double-Blind, Placebo Controlled, Randomized, Parallel-Group Study to Evaluate the Clinical Effect of Oral Montelukast Versus Placebo in Persistent Asthma Which is Also Active During Allergy Seasons in Pediatric Patients With Seasonal Aeroallergen Sensitivity

This is a 3-week study to evaluate FEV1 following treatment with drugs in persistent asthma which is also active during allergy seasons in pediatric patients with seasonal aeroallergen sensitivity.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 421
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 14 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and female patients, ages 6 to 14 years, with persistent asthma that is also active during allergy season
• Patients must demonstrate positive skin prick tests to seasonally relevant geographic aeroallergens

Exclusion Criteria:

• Patient cannot have any other acute or chronic pulmonary disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: 2; placebo	Drug: Comparator: Placebo; Placebo. Up to 3 weeks of treatment
EXPERIMENTAL: 1; montelukast	Drug: montelukast sodium; montelukast 5 mg chewable tablet once daily. Up to 3 weeks of treatment.; Other Names: MK0476

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 3	Percent change from baseline in FEV1, a measure of airway function, at Week 3	Baseline and week 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in Mean Daily "as Needed" β-agonist Use Over the 3-week Treatment Period	Percent change from baseline in average daily β-agonist use over the 3-week treatment period	Baseline and Week 3

Collaborators and Investigators

• Sponsor: Organon and Co

Publications and helpful links

General Publications

• Papadopoulos NG, Philip G, Giezek H, Watkins M, Smugar SS, Polos PG. The efficacy of montelukast during the allergy season in pediatric patients with persistent asthma and seasonal aeroallergen sensitivity. J Asthma. 2009 May;46(4):413-20. doi: 10.1080/02770900902847727. Erratum In: J Asthma. 2009 Oct;46(8):858.

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (ACTUAL): July 1, 2007
• Study Completion (ACTUAL): July 1, 2007

Study Registration Dates

• First Submitted: February 7, 2006
• First Submitted That Met QC Criteria: February 8, 2006
• First Posted (ESTIMATE): February 10, 2006

Study Record Updates

• Last Update Posted (ACTUAL): February 2, 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; 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: 0476-336; 2006_001