At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 276 enrolled
Drug / intervention
montelukast sodium +1 moredrug
Likely dose
Montelukast IV 5.25 mg lyophilized reconstituted in 20 mL of 3.3% dextrose/0.3% sodium chlorideAI-extracted
Key inclusion· 2
- ✓Age 6 to 14 years
- ✓Acute asthma attack presenting to emergency department
Key exclusion· 2
- ✕Other respiratory conditions or congenital lung abnormalities that would complicate asthma treatment
- ✕Other acute illnesses that would complicate asthma treatment and response assessment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating montelukast sodium and Comparator: placebo (unspecified) for Asthma. Completed, enrolled 276 participants.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2005
First PostedJul 2005
Primary CompletionMar 2008
TodayJul 2026
First PostedJul 6, 2005
Enrollment StartJul 1, 2005
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 21.0 years ago
Interventions
montelukast sodiumdrug
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
Comparator: placebo (unspecified)drug
Pbo for a study approximately 120 minutes in duration