A Study to Assess the Effect of Montelukast Sodium With Concomitant Administration of Inhaled Budesonide in Asthmatic Patients.
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: MK0476; montelukast sodium/Duration of Treatement: 16 weeks (Drug); Comparator: placebo / Duration of Treatment: 16 weeks (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
A study to assess the clinical effect of montelukast sodium with concomitant administration
of inhaled budesonide in asthmatic patients.
Clinical Details
Official title: A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Two-Period, Parallel-Group Study to Assess the Effect of Montelukast Sodium With Concomitant Administration of Inhaled Budesonide in Asthmatic Patients.
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Percentage of days of asthma exacerbations
Secondary outcome: Percentage of asthma free daysPercentage of nocturnal awakenings Beta agonist use
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Males or females between the ages of 18 and 70 with asthma
Locations and Contacts
Merck Sharp & Dohme De Espana, S.A.E., Madrid 28027, Spain
Additional Information
Starting date: March 1998
Last updated: October 25, 2005
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