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

Organon and Co500 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

500

Conditions

Asthma

Interventions

MK0476, montelukast sodium / Duration of Treatment: 4 weeksDRUG

Comparator: placebo / Duration of Treatment: 4 weeksDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Asthma symptoms brought on by allergies Exclusion Criteria: * Patient has any lung disease * Currently have a sinus infection or cold symptoms

Outcomes

Primary Outcomes

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

Secondary Outcomes

To assess the following over a 3-week treatment period:

nighttime symptoms

AM PEFR

PM PEFR

B-agonist use

asthma attacks

discontinuations due to asthma

Data from ClinicalTrials.gov

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