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

Phase 4

Completed

• Conditions: Asthma; Allergic Rhinitis

• Registration Number: NCT00157937
• Lead Sponsor: Organon and Co

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-02
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-12
• Status Verified: 2022-01
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Males or females between the ages of 18 and 60 with mild to moderate asthma

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
FEV1

Secondary Outcome Measures

Name	Time	Method
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