Pediatric Allergic Asthma Study

This is a 3-week study to evaluate FEV1 following treatment with drugs in persistent asthma which is also active during allergy seasons in pediatric patients with seasonal aeroallergen sensitivity...

Date First Received: February 7, 2006

Last Updated: June 26, 2009

Verified by: Merck, June 2009

Clinical Trial Phase: Phase 3 | Start Date: March 2006

Overall Status: Completed

Estimated Enrollment: 421

Brief Summary

Official Title: “A Multicenter, Double-Blind, Placebo Controlled,Randomized, Parallel-Group Study to Evaluate the Clinical Effect of Oral Montelukast Versus Placebo in Persistent Asthma Which is Also Active During Allergy Seasons in Pediatric Patients With Seasonal Aeroallergen Sensitivity”

Condition Keyword(s):

This is a 3-week study to evaluate FEV1 following treatment with drugs in persistent asthma which is also active during allergy seasons in pediatric patients with seasonal aeroallergen sensitivity.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: July 2007

Intervention(s) in this Clinical Trial

  • Drug: montelukast sodium
    • Arm 1: montelukast 5mg chewable tablet once daily. Up to 3 weeks of treatment.
  • Drug: Comparator: Placebo (unspecified)
    • Arm 2: Placebo. Up to 3 weeks of treatment.

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: 1
    • montelukast
  • Placebo Comparator: 2
    • Placebo

Outcome Measures for this Clinical Trial

Primary Measures

  • Percent change from baseline in Forced Expiratory Volume in 1 minute (FEV1)
    • Time Frame: 3 Weeks
      Safety Issue?: No

Secondary Measures

  • Percent change from baseline in mean daily "as needed" rescue medication use
    • Time Frame: 3 Weeks
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Male and female patients, ages 6 to 14 years, with persistent asthma that is also active during allergy season. Patients must demonstrate positive skin prick tests to seasonally relevant geographic aeroallergens

Exclusion Criteria:

  • Patient cannot have any other acute or chronic pulmonary disorder

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 Sponsor Information

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Related Publications

References

Papadopoulos NG, Philip G, Giezek H, Watkins M, Smugar SS, Polos PG. The efficacy of montelukast during the allergy season in pediatric patients with persistent asthma and seasonal aeroallergen sensitivity. J Asthma. 2009 May;46(4):413-20.

Additional Information

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00289874

Study ID Number: 2006_001

ClinicalTrials.gov Identifier: NCT00289874

Health Authority: United States: Food and Drug Administration

Clinical Trials Authorship and Review

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