A Study of an Intravenous Drug in Pediatric Patients With Acute Asthma (0476-301)

Study Overview
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Brief Summary
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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.

Detailed Description
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The duration of treatment is a one time dose.

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Drug: montelukast sodium
* Drug: Comparator: placebo (unspecified)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo | Drug: Comparator: placebo (unspecified)<br>* Pbo for a study approximately 120 minutes in duration<br>|
| Active Comparator: 2<br>montelukast sodium | Drug: montelukast sodium<br>* 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<br>* Other names: SINGULAIR®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in FEV1 (Forced Expiratory Volume in 1 Second) Over the First 60 Minutes After Administration | Improvement in FEV1 as the time-weighted average change from baseline over 60 minutes following the end of study drug administration. Time-weighted average of the changes from baseline obtained over the 60 minutes (at 60, 45, 30 and 15) with the time interval between any measurement and the measurement prior to it used as the weighting factor. | Baseline and (time weighted average over) 60 Minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Modified Pulmonary Index [mPI] Score | Change from baseline in modified pulmonary index [mPI] score assessed 60 minutes following the end of study drug administration. mPI questionnaire scores each component on a scale of 0 to 3 (low to high) with a total possible score of 12. The components are respiratory rate, wheezing, prolongation of expiration (Inspiratory:Expiratory ratio), and accessory muscle use. | Baseline and 60 minutes | 
| Number of Participants With Treatment Failure (Hospitalization or Time to Decision to Discharge > 2 Hours) | Treatment Failure is defined as a.) patients who required hospitalization, or b.) patients for whom a decision to discharge home has not been reached by 2 hours following the end of study drug administration. | 120 minutes | 
| Time-Weighted Average Change in FEV1 Over 45 Minutes Following the End of Study Drug Administration | Improvement in FEV1 as time-weighted average change from baseline over 45 minutes following the end of study drug administration: Time-weighted average of the changes from baseline obtained over the 45 minutes (at 45, 30 and 15) with the time interval between any measurement and the measurement prior to it used as the weighting factor. | Baseline and (time-weighed average over) 45 Minutes | 
| Time-Weighted Average Change in FEV1 Over 30 Minutes Following the End of Study Drug Administration | Improvement in FEV1 as the time-weighted average change from baseline over 30 minutes following the end of study drug administration. Time-weighted average of the changes from baseline obtained over the 30 minutes (at 30 and 15) with the time interval between any measurement and the measurement prior to it used as the weighting factor. | Baseline and (time-weighted average over) 30 Minutes | 
| Change in FEV1 After 15 Minutes Following the End of Study Drug Administration | Improvement in FEV1 as the time-weighted average change from baseline over the first 15 minutes following the end of study drug administration. Change = 15 minutes value minus Baseline value | Baseline and 15 Minutes | 
| Total Dose of β-agonist Administered Per Patient Over a Period of 2 Hours Following the End of Study Drug Administration | Median total dose of β-agonist administered per patient over a period of 2 hours following the end of study drug administration. | 120 minutes |