A Study to Evaluate MK0476 and Fluticasone to Control Asthma in Patients With Mild Persistent Asthma
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma, Bronchial
Intervention: MK0476, montelukast sodium / Duration of Treatment: 1 Year (Drug); Comparator : fluticasone propionate / Duration of Treatment: 1 Year (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
A study to evaluate MK0476 and Fluticasone to control asthma in patients with mild persistent
asthma.
Clinical Details
Official title: A Double-Blind, Randomized, Double-Dummy, Multicenter Study to Evaluate and Compare Oral Montelukast and Inhaled Fluticasone in the Control of Asthma for 6- to 14-Year-Olds With Mild Persistent Asthma
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Improvement of asthma with MK0476 and Fluticasone as measured by number of asthma rescue-free days
Secondary outcome: Improved effect of MK0476 and fluticasone on FEV1 values
Eligibility
Minimum age: 6 Years.
Maximum age: 14 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patient is male or female, 6-14 years of age with mild persistent asthma
- Patient has a history of the following symptoms: wheezing, chest tightness, cough,
etc.
- Patient has asthma diagnosed by a doctor
Exclusion Criteria:
- Patient is hospitalized
- Patient has had major surgery or participated in another clinical trial in the last 4
weeks
- Patient has been on a breathing tube for asthma
Locations and Contacts
Additional Information
Related publications: Garcia Garcia ML, Wahn U, Gilles L, Swern A, Tozzi CA, Polos P. Montelukast, compared with fluticasone, for control of asthma among 6- to 14-year-old patients with mild asthma: the MOSAIC study. Pediatrics. 2005 Aug;116(2):360-9. Erratum in: Pediatrics. 2005 Oct;116(4):1058.
Starting date: July 2001
Ending date: June 2003
Last updated: October 8, 2007
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