A Study of an Intravenous Drug in Pediatric Patients With Acute Asthma

Verified by: Merck, April 2010
First Received: June 30, 2005 | Last Updated: April 7, 2010 | Phase: Phase 3 | Start Date: August 2005
Overall Status: Completed | Estimated Enrollment: 276
  • …
  • Tell a FriendPrint

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...

Brief Summary

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

Detailed Clinical Trial Description

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

Outcome Measures for this Clinical Trial

Primary Measures

  • Improvement in FEV1 (Forced Expiratory Volume in 1 Second) Over the First 60 Minutes After Administration
    • Time Frame: Baseline and (time weighted average over) 60 Minutes
      Safety Issue?: No

Secondary Measures

  • Change From Baseline in Modified Pulmonary Index [mPI] Score
    • Time Frame: Baseline and 60 minutes
      Safety Issue?: No
  • Number of Participants With Treatment Failure (Hospitalization or Time to Decision to Discharge > 2 Hours)
    • Time Frame: 120 minutes
      Safety Issue?: No
  • Time-Weighted Average Change in FEV1 Over 45 Minutes Following the End of Study Drug Administration
    • Time Frame: Baseline and (time-weighed average over) 45 Minutes
      Safety Issue?: No
  • Time-Weighted Average Change in FEV1 Over 30 Minutes Following the End of Study Drug Administration
    • Time Frame: Baseline and (time-weighted average over) 30 Minutes
      Safety Issue?: No
  • Change in FEV1 After 15 Minutes Following the End of Study Drug Administration
    • Time Frame: Baseline and 15 Minutes
      Safety Issue?: No
  • Total Dose of β-agonist Administered Per Patient Over a Period of 2 Hours Following the End of Study Drug Administration
    • Time Frame: 120 minutes
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

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 12, 2012

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

  • …
  • Tell a FriendPrint

Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00117338