A Study to Compare Effectiveness of Montelukast Sodium With Comparator in Mild to Moderate Persistent Asthmatics (0476-329)

Organon and Co31 enrolled

Overview

Subjects have 8-week with montelukast sodium or comparator drug administration period, 2-week wash-out period and 8-week comparator drug or the drug administration period (with cross-over design) for assessment of the drug efficacy, safety and tolerability.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Asthma Allergic Rhinitis

Interventions

MK0476; montelukast sodium/Duration of Treatment: 16 weeksDRUG

Comparator: theophylline ER/Duration of Treatment: 16 weeksDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Males or females between the ages of 18 and 60 with mild to moderate asthma

Outcomes

Primary Outcomes

FEV1

Secondary Outcomes

AM-PEFR; daytime symptom score; treatment frequency of beta agonist; global assessment investigator's symptom assessment; Quality of Life Questionnaire for Adult Korean Asthmatics; QLQAKA

Data from ClinicalTrials.gov

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