A study to assess the clinical effect of montelukast sodium with concomitant administration of inhaled budesonide in asthmatic patients.
Full Title of Study: “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 Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: October 2000
- Drug: MK0476; montelukast sodium/Duration of Treatment: 16 weeks
- Drug: Comparator: placebo / Duration of Treatment: 16 weeks
Clinical Trial Outcome Measures
- Percentage of days of asthma exacerbations
- Percentage of asthma free days
- Percentage of nocturnal awakenings
- Beta agonist use
Participating in This Clinical Trial
- Males or females between the ages of 18 and 70 with asthma
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 70 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Merck Sharp & Dohme Corp.
- Provider of Information About this Clinical Study
- Overall Official(s)
- Medical Monitor, Study Director, Merck Sharp & Dohme Corp.
Citations Reporting on Results
Vaquerizo MJ, Casan P, Castillo J, Perpiña M, Sanchis J, Sobradillo V, Valencia A, Verea H, Viejo JL, Villasante C, Gonzalez-Esteban J, Picado C; CASIOPEA (Capacidad de Singulair Oral en la Prevencion de Exacerbaciones Asmaticas) Study Group. Effect of montelukast added to inhaled budesonide on control of mild to moderate asthma. Thorax. 2003 Mar;58(3):204-10. Erratum in: Thorax. 2003 Apr;58(4):370.
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