A Study of an Intravenous Drug in Pediatric Patients With Acute Asthma (0476-301)
- Registration Number
- NCT00117338
- Lead Sponsor
- Organon and Co
- Brief 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.
- Detailed Description
The duration of treatment is a one time dose.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 276
- Children 6-14 years of age seeking treatment in emergency departments with acute asthma attacks
- Other respiratory conditions (including congenital lung abnormalities) or other acute illnesses that would complicate current treatment and response for asthma
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 montelukast sodium montelukast sodium
- Primary Outcome Measures
Name Time Method Improvement in FEV1 (Forced Expiratory Volume in 1 Second) Over the First 60 Minutes After Administration Baseline and (time weighted average over) 60 Minutes 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.
- Secondary Outcome Measures
Name Time Method Change in FEV1 After 15 Minutes Following the End of Study Drug Administration Baseline and 15 Minutes 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
Time-Weighted Average Change in FEV1 Over 30 Minutes Following the End of Study Drug Administration Baseline and (time-weighted average over) 30 Minutes 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.
Total Dose of β-agonist Administered Per Patient Over a Period of 2 Hours Following the End of Study Drug Administration 120 minutes Median total dose of β-agonist administered per patient over a period of 2 hours following the end of study drug administration.
Change From Baseline in Modified Pulmonary Index [mPI] Score Baseline and 60 minutes 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-Weighted Average Change in FEV1 Over 45 Minutes Following the End of Study Drug Administration Baseline and (time-weighed average over) 45 Minutes 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.
Number of Participants With Treatment Failure (Hospitalization or Time to Decision to Discharge > 2 Hours) 120 minutes 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.