Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00393367
Status:
COMPLETED
Last Update Posted:
2012-08-10
First Post:
2006-10-25
Brief Title:
Budesonide Inhalation Suspension for Acute Asthma in Children
Sponsor:
Childrens Hospital of Philadelphia
Organization:
Childrens Hospital of Philadelphia
Study Overview
Official Title:
Budesonide Inhalation Suspension for Acute Asthma in Children
Status:
COMPLETED
Status Verified Date:
2012-08
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:
The purpose of this study is to determine whether the addition of budesonide inhalation suspension BIS to the standard therapy of albuterol ipratropium bromide and systemic corticosteroids SCS for moderate to severe asthma flares in children reduces asthma severity more rapidly than standard therapy alone
Detailed Description:
Context Acute asthma is a leading cause of emergency department ED visits and hospitalizations Although standard therapy for acute asthma includes systemic corticosteroids SCS these drugs take many hours to have an effect Recent studies demonstrate that inhaled corticosteroids ICS may improve patients asthma severity more rapidly than SCS and may decrease hospitalizations Only a few small studies have evaluated ICS added to standard therapy for acute asthma in children
Objective To determine if adding the nebulized steroid budesonide to standard therapy including SCS improves patients asthma severity faster than standard therapy alone and leads to fewer hospitalizations
Study DesignSettingParticipants A double-blind randomized controlled trial of budesonide inhalation suspension BIS versus placebo for children 2 to 18 years of age who present to a tertiary care urban pediatric ED with a moderate to severe asthma flare
Intervention Participants will receive standard therapy including SCS albuterol and ipratropium bromide and will be randomly assigned to also receive either nebulized BIS or saline
Study Measures Differences in asthma scores vital signs and the need for hospitalization will be compared between treatment groups
Objective To determine if adding the nebulized steroid budesonide to standard therapy including SCS improves patients asthma severity faster than standard therapy alone and leads to fewer hospitalizations
Study DesignSettingParticipants A double-blind randomized controlled trial of budesonide inhalation suspension BIS versus placebo for children 2 to 18 years of age who present to a tertiary care urban pediatric ED with a moderate to severe asthma flare
Intervention Participants will receive standard therapy including SCS albuterol and ipratropium bromide and will be randomly assigned to also receive either nebulized BIS or saline
Study Measures Differences in asthma scores vital signs and the need for hospitalization will be compared between treatment groups
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