Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Asthmatic Patients

Verified by: Merck, April 2010
First Received: June 30, 2005 | Last Updated: April 7, 2010 | Phase: Phase 3 | Start Date: December 2005
Overall Status: Completed | Estimated Enrollment: 154
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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...

Brief Summary

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: November 2008

Intervention(s) in this Clinical Trial

  • Drug: montelukast sodium
    • montelukast/Pbo 5 mg chewable tablet once daily montelukast 5 mg 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/placebo (Pbo) 5 mg chewable tablet once daily; inhaled salmeterol Pbo 100 ug (2 puffs, twice daily; inhaled fluticasone 200 ug/day for 4 weeks of treatment; montelukast 5 mg 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 5 mg 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 5 mg 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 5 mg 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 5 mg chewable tablet once daily; inhaled salmeterol 100 ug (2 puffs, twice daily); inhaled fluticasone 200 ug/day for 4 weeks of treatment; montelukast Pbo 5 mg chewable tablet once daily; inhaled salmeterol Pbo 100 ug (2 puffs, twice daily); inhaled fluticasone 200 ug/day for 2 weeks of treatment; montelukast 5 mg chewable tablet once daily; inhaled salmeterol Pbo 100 ug (2 puffs, twice daily; inhaled fluticasone 200 ug/day for 4 weeks of treatment.

Outcome Measures for this Clinical Trial

Primary Measures

  • Maximum Post-exercise Percent Fall in FEV1
    • Time Frame: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
      Safety Issue?: No

Secondary Measures

  • Area Under the Curve for Percent-change From Pre-exercise Baseline FEV1 in Liters (L), From 0 to 20 Minutes (AUC(0-20))
    • Time Frame: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
      Safety Issue?: No
  • Maximum FEV1 Percent Predicted Following First Beta-agonist Use
    • Time Frame: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
      Safety Issue?: No
  • Time to Recovery to Within 5 Percent of Baseline FEV1
    • Time Frame: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
      Safety Issue?: No
  • Average (Avg) Percent (%) Change in FEV1 After First Beta (β)-Agonist Use and Prior to Second Beta-agonist Use
    • Time Frame: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: Merck Industry

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

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

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

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00127166