Phase 3 N=276 Randomized Double-blind Treatment

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

Asthma

Bottom Line

View on ClinicalTrials.gov: NCT00117338 ↗

Enrolled (actual)

276

Serious AEs

—

Results posted

Aug 2009

Primary outcome: Primary: Improvement in FEV1 (Forced Expiratory Volume in 1 Second) Over the First 60 Minutes After Administration — 0.08; 0.07 Liters — p=0.775

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: montelukast sodium (Drug); Comparator: placebo (unspecified) (Drug)
Age: Pediatric · 6+ yrs
Sex: All
Sponsor: Organon and Co
Primary completion: Mar 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Improvement in FEV1 (Forced Expiratory Volume in 1 Second) Over the First 60 Minutes After Administration	0.08; 0.07	0.775
SECONDARY Change From Baseline in Modified Pulmonary Index [mPI] Score	-2.95; -2.96	0.931
SECONDARY Number of Participants With Treatment Failure (Hospitalization or Time to Decision to Discharge > 2 Hours)	28; 33; 37; 26	0.975
SECONDARY Time-Weighted Average Change in FEV1 Over 45 Minutes Following the End of Study Drug Administration	0.07; 0.05	0.612
SECONDARY Time-Weighted Average Change in FEV1 Over 30 Minutes Following the End of Study Drug Administration	0.06; 0.05	0.774
SECONDARY Change in FEV1 After 15 Minutes Following the End of Study Drug Administration	0.06; 0.01	0.173
SECONDARY Total Dose of β-agonist Administered Per Patient Over a Period of 2 Hours Following the End of Study Drug Administration	1.0; 0.6	0.580

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00117338). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.