A Study to Compare Effectiveness of Montelukast Sodium With Comparator in Mild to Moderate Persistent Asthmatics
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma; Allergic Rhinitis
Intervention: MK0476; montelukast sodium/Duration of Treatment: 16 weeks (Drug); Comparator: theophylline ER/Duration of Treatment: 16 weeks (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
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.
Clinical Details
Official title: A Randomized, Open Label, Cross-Over Study Comparing Effectiveness for the Montelukast Sodium With Comparator in Mild to Moderate Persistent Asthmatics
Study design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Primary outcome: FEV1
Secondary outcome: 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
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Males or females between the ages of 18 and 60 with mild to moderate asthma
Locations and Contacts
MSD Korea Ltd., Seoul 121-705, Korea, Republic of
Additional Information
Starting date: May 2003
Last updated: February 2, 2007
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