Official Title: “A Multicenter, Double-Blind, Randomized, Crossover Design Study to Evaluate the Effect of Montelukast Vs. Salmeterol on the Inhibition of Exercise-Induced Bronchoconstriction in Asthmatic Patients Aged 6-14 Years”

The purpose of this study is to determine the effect of four weeks of treatment with two investigational drugs (oral versus inhaled administration) plus an inhaled medication in the treatment of airway constriction brought on by exercise in asthmatic patients.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment, Safety/Efficacy Study

Study Primary Completion Date: November 2008

Intervention(s) in this Clinical Trial

• Drug: montelukast sodium
  • montelukast/Pbo 5mg chewable tablet once daily montelukast 5mg chewable tablet once daily
• Drug: Comparator: salmeterol
  • inhaled salmeterol Pbo 100 ug (2 puffs, twice daily inhaled salmeterol 100 ug (2 puffs, twice daily
• Drug: Comparator: fluticasone
  • inhaled fluticasone 200 ug/day

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Crossover Study: Arm 1: montelukast/Pbo 5mg chewable tablet once daily; inhaled salmeterol Pbo 100 ug (2 puffs, twice daily; inhaled fluticasone 200 ug/day for 4 weeks of treatment; montelukast 5mg chewable tablet once daily; inhaled salmeterol Pbo 100 ug (2 puffs, twice daily; inhaled fluticasone 200 ug/day for 4 weeks of treatment; montelukast Pbo 5mg chewable tablet once daily; inhaled salmeterol Pbo 100 ug (2 puffs, twice daily; inhaled fluticasone 200 ug/day for 2 weeks of treatment; montelukast Pbo 5mg chewable tablet once daily; inhaled salmeterol 100 ug (2 puffs, twice daily; inhaled fluticasone 200 ug/day for 4 weeks of treatment.
• Experimental: 2
  • Crossover Study: Arm 2: montelukast Pbo 5mg chewable tablet once daily; inhaled salmeterol Pbo 100 ug (2 puffs, twice daily); inhaled fluticasone 200 ug/day for 4 weeks of treatment; montelukast Pbo 5mg chewable tablet once daily; inhaled salmeterol 100 ug (2 puffs, twice daily); inhaled fluticasone 200 ug/day for 4 weeks of treatment; montelukast Pbo 5mg chewable tablet once daily; inhaled salmeterol Pbo 100 ug (2 puffs, twice daily); inhaled fluticasone 200 ug/day for 2 weeks of treatment; montelukast 5mg chewable tablet once daily; inhaled salmeterol Pbo 100 ug (2 puffs, twice daily; inhaled fluticasone 200 ug/day for 4 weeks of treatment.

Primary Measures

• Maximum Post-exercise Percent Fall in FEV1
  • Time Frame: 4 weeks
    Safety Issue?: No

Secondary Measures

• Area under the curve from 0 to 20 minutes (AUC(0-20))
  • Time Frame: 4 weeks
    Safety Issue?: No
• Maximum FEV1 percent predicted following first beta-agonist use
  • Time Frame: 4 weeks
    Safety Issue?: No
• Time to recovery to within 5% of baseline FEV1
  • Time Frame: 4 weeks
    Safety Issue?: No
• Average percent change in FEV1 after first beta-agonist use and prior to second beta-agonist use
  • Time Frame: 4 weeks
    Safety Issue?: No

Inclusion Criteria:

• 6-14 year old children with a history of asthma for at least 12 months
• Patients must demonstrate airway constriction brought on by exercise

Exclusion Criteria:

• Patient is taking any medications that are not allowed in the study

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: 14 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00127166

Study ID Number: 2004_006

ClinicalTrials.gov Identifier: NCT00127166

Health Authority: Italy: Ministry of Health

MedWatch - FDA maintained medical product safety Information

PhRMA Clinical Study Results Database - web-based repository for clinical study results

Merck: Patient & Caregiver U.S. Product Web Site