A Study of MK0476 in the Treatment of Asthma Patients Aged 2-5 Years (0476-907)

A study to determine the efficacy of MK0476 in the Treatment of Asthmatic Patients Aged 2 to 5 Years.

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

2 year–5 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 or Female between and including the ages of 2 and 5 years
Patient was treated with steroids for an asthma episode in the last 3 months
Patient was admitted to the hospital or emergency room in the last 3 months
Patient is able to chew a tablet

Exclusion criteria

Patient has been in a research study in the past 4 weeks
Patient has visited the emergency room for an asthma episode in the past week
Patients has a history of stomach, heart, liver, nerve, kidney or blood disease

Treatment and study plan

Montelukast

Drug

One montelukast 4-mg chewable tablet (CT) administered once daily at bedtime. Duration of Treatment: 48 Weeks

Other names: MK0476, SINGULAIR ®

Placebo (unspecified)

Drug

Matching-image Montelukast placebo. Duration of Treatment: 48 Weeks

Primary outcomes

asthma episodes in 2 - 5 year old children

Time frame: at 12 months

Secondary outcomes

the number of treatments and duration of asthma episodes

Time frame: at 12 months

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 Determine the Efficacy of Montelukast in the Treatment of Exacerbations in Asthmatic Patients Aged 2-to-5 Years

Important dates

Study start: 2001
Primary completion: 2002
Study completion: 2002
First posted: Jun 19, 2008
Registry last updated: Aug 15, 2024

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