A Study to Assess the Effect of Montelukast Sodium With Concomitant Administration of Inhaled Budesonide in Asthmatic Patients (0476-075)


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

  • 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

Primary Measures

  • Percentage of days of asthma exacerbations

Secondary Measures

  • Percentage of asthma free days
  • Percentage of nocturnal awakenings
  • Beta agonist use

Participating in This Clinical Trial

Inclusion Criteria

  • 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

Investigator Details

  • Lead Sponsor
    • Merck Sharp & Dohme Corp.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Monitor, Study Director, Merck Sharp & Dohme Corp.

Citations Reporting on Results

Vaquerizo MJ, Casan P, Castillo J, PerpiƱa 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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