Study of an Approved Drug in Patients With Asthma (0476-289)(COMPLETED)

A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study to Evaluate the Clinical Effect of Oral MK0476 Vs Placebo During the Allergy Season in Patients With Seasonal Aeroallergen Sensitivity and Chronic Asthma Which is Also Active During Allergy Season

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00092144

Enrollment

500

Registered

2004-09-24

Start date

2004-02-26

Completion date

2004-06-15

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

The purpose of this study is to assess the efficacy and safety of an approved drug on asthma symptoms in patients with chronic asthma which is also active during the allergy season.

Interventions

DRUGMK0476, montelukast sodium / Duration of Treatment: 4 weeks

DRUGComparator: placebo / Duration of Treatment: 4 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Asthma symptoms brought on by allergies

Exclusion criteria

* Patient has any lung disease * Currently have a sinus infection or cold symptoms

Design outcomes

Primary

Measure	Time frame
To assess daytime asthma symptoms as measured by daily diaries over a 3-week treatment period	—

Secondary

Measure	Time frame
nighttime symptoms	—
AM PEFR	—
PM PEFR	—
To assess the following over a 3-week treatment period:	—
asthma attacks	—
discontinuations due to asthma	—
B-agonist use	—

Outcome results

None listed

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