Phase 3
Completed N=276
A Study of an Intravenous Drug in Pediatric Patients With Acute Asthma (0476-301)
Source: ClinicalTrials.gov NCT00117338 ↗Enrolled (actual)
276
Serious AEs
—
Results posted
Aug 2009
Primary outcomePrimary: Improvement in FEV1 (Forced Expiratory Volume in 1 Second) Over the First 60 Minutes After Administration — 0.08; 0.07 Liters — p=0.775
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.
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 |
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
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. Informational only — not medical advice.