Official Title: “A Multicenter, Randomized, Double-Blind Study Comparing the Clinical Effects of Intravenous Montelukast With Placebo in Pediatric Patients (Ages 6 to 14 Years) With Acute Asthma”

This study will attempt to find out if the addition of an intravenous form of a drug that is already used for treating asthma in children, will help resolve asthma attacks faster than using the current standard care alone.

Study Type: Interventional

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

Study Primary Completion Date: March 2008

The duration of treatment is a one time dose.

Intervention(s) in this Clinical Trial

• Drug: montelukast sodium
  • Montelukast IV 5.25 mg lyophilized (reconstituted in 20 mL of 3.3% dextrose/0.3% sodium chloride) for a study approximately 120 minutes in duration
• Drug: Comparator: placebo (unspecified)
  • Pbo for a study approximately 120 minutes in duration

Arms, Groups and Cohorts in this Clinical Trial

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

Primary Measures

• Improvement in FEV1 over the first 60 minutes after administration
  • Time Frame: 120 Minutes
    Safety Issue?: No

Inclusion Criteria:

• Children 6-14 years of age seeking treatment in emergency departments with acute asthma attacks

Exclusion Criteria:

• Other respiratory conditions (including congenital lung abnormalities) or other acute illnesses that would complicate current treatment and response for asthma

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 August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00117338

Study ID Number: 2005_026

ClinicalTrials.gov Identifier: NCT00117338

Health Authority: United States: Food and Drug Administration