Montelukast Added to Standard Therapy for Acute Asthma in Children Age 6-14 Years

Asthma Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

• NCT number: NCT00353184
• Study type: Interventional
• Source: Washington University School of Medicine
• Status: Terminated
• Phase: N/A
• Start date: September 2001
• Completion date: February 2005