Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00353184
Status:
TERMINATED
Last Update Posted:
2010-02-24
First Post:
2006-07-17
Brief Title:
Montelukast Added to Standard Therapy for Acute Asthma in Children Age 6-14 Years
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Randomized Controlled Trial of Oral Montelukast Added to Standard Therapy for Acute Asthma Exacerbations in Children Age 6 to 14 Years
Status:
TERMINATED
Status Verified Date:
2010-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Results of the interim analysis suggested no significant diff between study groups
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Oral montelukast is helpful in chronic asthma The purpose of this pediatric study was to investigate whether the addition of oral montelukast to standard therapy for acute asthma exacerbations results in further improvement in breathing function over three hours
Detailed Description:
We hypothesized that children with moderate acute asthma exacerbations receiving oral montelukast in addition to standard therapy will have at least 12 greater FEV1 improvement in three hours than those receiving standard therapy alone
In this randomized double-blind placebo-controlled study we enrolled emergency patients aged 6-14 years with moderate acute asthma exacerbations initial PEFR 40-70 predicted Subjects received montelukast 5-mg or placebo orally then standard therapy consisting of weight-based doses of nebulized albuterol nebulized ipratropium bromide and oral corticosteroids We measured FEV1 before study medication administration and hourly for three hours
We conducted a planned an interim analysis after approximately one-half of the estimated sample had been enrolled
In this randomized double-blind placebo-controlled study we enrolled emergency patients aged 6-14 years with moderate acute asthma exacerbations initial PEFR 40-70 predicted Subjects received montelukast 5-mg or placebo orally then standard therapy consisting of weight-based doses of nebulized albuterol nebulized ipratropium bromide and oral corticosteroids We measured FEV1 before study medication administration and hourly for three hours
We conducted a planned an interim analysis after approximately one-half of the estimated sample had been enrolled
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