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

Organon and Co276 enrolled

Overview

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.

The duration of treatment is a one time dose.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

276

Conditions

Asthma

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

Eligibility

Sex: ALLMin age: 6 YearsMax age: 14 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Baseline and (time weighted average over) 60 Minutes

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline and (time-weighed average over) 45 Minutes

Data from ClinicalTrials.gov

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