An interventional study of Montelukast 5-mg orally added to standard therapy in Asthma, sponsored by Washington University School of Medicine. Terminated at 1 site in United States. Open to participants aged 6 Years to 14 Years. Per ClinicalTrials.gov, last updated 2010-02-24.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Treatment
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.
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 27 is below the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Forced Expiratory Volume in One Second (FEV1)
Hospitalization Rate
Relapse Visit Rate
This study is terminated, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.
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Washington University School of Medicine