Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00124176
Status:
COMPLETED
Last Update Posted:
2013-03-14
First Post:
2005-07-25
Brief Title:
Continuous Levalbuterol for Treatment of Status Asthmaticus in Children
Sponsor:
Childrens Hospital of Philadelphia
Organization:
Childrens Hospital of Philadelphia
Study Overview
Official Title:
Continuous Levalbuterol for Treatment of Status Asthmaticus in Children
Status:
COMPLETED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will use a randomized double-blind controlled trial design in order to assess the safety and efficacy of levalbuterol LEV compared to racemic albuterol RAC when delivered continuously in a high-dose regimen for children with severe exacerbations of asthma
Primary hypothesis
Children with severe asthma receiving continuous levalbuterol will have a shorter duration of continuous therapy as compared to racemic albuterol
Secondary hypotheses
Children receiving continuous levalbuterol will have improved lung function measured by forced expiratory volume at 1 second FEV1 as compared to racemic albuterol
Children receiving continuous levalbuterol will have improved clinical asthma score as compared to racemic albuterol
Primary hypothesis
Children with severe asthma receiving continuous levalbuterol will have a shorter duration of continuous therapy as compared to racemic albuterol
Secondary hypotheses
Children receiving continuous levalbuterol will have improved lung function measured by forced expiratory volume at 1 second FEV1 as compared to racemic albuterol
Children receiving continuous levalbuterol will have improved clinical asthma score as compared to racemic albuterol
Detailed Description:
High-dose nebulized albuterol is standard therapy for severe asthma exacerbations at The Childrens Hospital of Philadelphia CHOP and other tertiary care pediatric hospitals throughout the United States For the most severe exacerbations albuterol is provided continuously at high doses until improvement is observed This regimen has been standardized in a treatment protocol that has been used at CHOP for more than 5 years Recently levalbuterol LEV the purified active R-enantiomer of albuterol has been approved for use in acute asthma Preliminary evidence suggests that LEV may improve pulmonary function and clinical outcomes in children with asthma based on studies using standard dosing regimens Laboratory and clinical evidence suggest that the S-enantiomer of albuterol may have detrimental effects that contribute to poor response to racemic albuterol RAC Limited data exist about the efficacy of LEV in high-dose regimens
This study will use a randomized double-blind controlled trial design in order to assess the safety and efficacy of LEV compared to RAC when delivered continuously in a high-dose regimen for severe exacerbations of asthma Children treated for asthma exacerbations in the CHOP emergency department ED will be eligible for study enrollment Those that meet enrollment criteria will be randomized to receive either high dose RAC according to the standard asthma care protocol or equivalent dosing of LEV Approximately 128 patients with 64 in each arm of the study will be enrolled An interim safety analysis will be conducted after the first 40 patients are enrolled This study should be completed in six to nine months The primary outcome will be duration of continuous therapy Secondary outcomes will include improvement of clinical asthma score and change in forced expiratory volume in one second FEV1 In addition R-albuterol and S-albuterol levels will be measured at study entry and at 6-hour intervals in the first 40 patients enrolled These values will be used to determine prior RAC exposure and to determine serum levels of R and S albuterol during continuous therapy
This study will use a randomized double-blind controlled trial design in order to assess the safety and efficacy of LEV compared to RAC when delivered continuously in a high-dose regimen for severe exacerbations of asthma Children treated for asthma exacerbations in the CHOP emergency department ED will be eligible for study enrollment Those that meet enrollment criteria will be randomized to receive either high dose RAC according to the standard asthma care protocol or equivalent dosing of LEV Approximately 128 patients with 64 in each arm of the study will be enrolled An interim safety analysis will be conducted after the first 40 patients are enrolled This study should be completed in six to nine months The primary outcome will be duration of continuous therapy Secondary outcomes will include improvement of clinical asthma score and change in forced expiratory volume in one second FEV1 In addition R-albuterol and S-albuterol levels will be measured at study entry and at 6-hour intervals in the first 40 patients enrolled These values will be used to determine prior RAC exposure and to determine serum levels of R and S albuterol during continuous therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None