A Study of an Intravenous Drug in Pediatric Patients With Acute Asthma
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: montelukast sodium (Drug); Comparator: placebo (unspecified) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
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.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Improvement in FEV1 over the first 60 minutes after administration
Detailed description:
The duration of treatment is a one time dose.
Eligibility
Minimum age: 6 Years.
Maximum age: 14 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: August 2005
Ending date: April 2008
Last updated: May 9, 2008
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