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

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.

Completed

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

montelukast sodium

Drug

montelukast 5 mg chewable tablet once daily. Up to 3 weeks of treatment.

Other names: MK0476

Comparator: placebo

Drug

Placebo. Up to 3 weeks of treatment

Primary outcomes

Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 3

Time frame: Baseline and week 3

Percent change from baseline in FEV1, a measure of airway function, at Week 3

Secondary outcomes

Percent Change From Baseline in Mean Daily "as Needed" β-agonist Use Over the 3-week Treatment Period

Time frame: Baseline and Week 3

Percent change from baseline in average daily β-agonist use over the 3-week treatment period

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2007
Study completion: 2007
First posted: Feb 10, 2006
Registry last updated: Feb 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed