A Study to Evaluate MK0476 and Fluticasone to Control Asthma in Patients With Mild Persistent Asthma (0476-910)

A Double-Blind, Randomized, Double-Dummy, Multicenter Study to Evaluate and Compare Oral Montelukast and Inhaled Fluticasone in the Control of Asthma for 6- to 14-Year-Olds With Mild Persistent Asthma

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00489346

Enrollment

994

Registered

2007-06-21

Start date

2001-10-31

Completion date

2002-06-30

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, Bronchial

Brief summary

A study to evaluate MK0476 and Fluticasone to control asthma in patients with mild persistent asthma.

Interventions

DRUGMK0476, montelukast sodium / Duration of Treatment: 1 Year

DRUGComparator : fluticasone propionate / Duration of Treatment: 1 Year

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

6 Years to 14 Years

Healthy volunteers

Inclusion criteria

* Patient is male or female, 6-14 years of age with mild persistent asthma * Patient has a history of the following symptoms: wheezing, chest tightness, cough, etc. * Patient has asthma diagnosed by a doctor

Exclusion criteria

* Patient is hospitalized * Patient has had major surgery or participated in another clinical trial in the last 4 weeks * Patient has been on a breathing tube for asthma

Design outcomes

Primary

Measure	Time frame
Improvement of asthma with MK0476 and Fluticasone as measured by number of asthma rescue-free days	Duration of Trial

Secondary

Measure	Time frame
Improved effect of MK0476 and fluticasone on FEV1 values	Duration of Trial

Outcome results

None listed

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