A Study to Determine the Effect of Montelukast Sodium as an Episode Modifier in the Treatment of Infrequent Episodic Asthma in Children (0476-165)

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Determine the Effect of Montelukast Sodium as an Episode Modifier in the Treatment of Infrequent Episodic Asthma in Children

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00140881

Enrollment

220

Registered

2005-09-01

Start date

2000-06-01

Completion date

2003-02-14

Last updated

2024-08-14

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

Conditions

Asthma

Brief summary

A 53-week study to determine the effect of montelukast sodium when given to children (with infrequent episodic asthma) at the earliest symptoms of an acute episode of asthma.

Interventions

DRUGMK0476; montelukast sodium

DRUGComparator: placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

2 Years to 14 Years

Healthy volunteers

Inclusion criteria

* Males or females between the ages of 2 and 14 who have infrequent episodic asthma.

Design outcomes

Primary

Measure	Time frame
Composite unscheduled acute health care resource utilisation (specific for asthma; unscheduled visits, GP attendance, ED attendance and hospital admission).	—

Secondary

Measure	Time frame
Parent/caregiver QOL endpoints.	—
The safety and tolerability of montelukast when use as an episode modifier.	—
The duration and severity of the episode assessed by the parent/caregiver symptom score and the use of b-agonist and oral corticosteroid.	—

Outcome results

None listed

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