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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00700661

Enrollment

500

Registered

2008-06-19

Start date

2001-01-31

Completion date

2002-12-31

Last updated

2024-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Brief summary

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

Interventions

DRUGmontelukast

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

DRUGplacebo (unspecified)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

2 Years to 5 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
asthma episodes in 2 - 5 year old children	at 12 months

Secondary

Measure	Time frame
the number of treatments and duration of asthma episodes	at 12 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026