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

Not Applicable

Terminated

• Conditions: Asthma

• Registration Number: NCT00353184
• Lead Sponsor: Washington University School of Medicine

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.

Study Timeline

• Study Start: 2001-09
• Primary Completion: 2004-10
• Study Completion: 2005-02
• Study First Submitted: 2006-07-17
• Study First Submitted QC: 2006-07-17
• Study First Posted: 2006-07-18
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-23
• Last Update Posted: 2010-02-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• Seeking care in ED for acute asthma exacerbation
• Age 6-14 years inclusive
• Initial FEV1 = 40-70% predicted (defined as moderate severity)
• Consent to participate in study

Exclusion Criteria

• Severe exacerbation requiring immediate therapy as determined by treating clinician
• Pregnancy by history
• Cystic Fibrosis by history
• Tuberculosis
• Gastroesophageal reflux disease requiring medications
• Acute or chronic liver disease
• Bronchopulmonary dysplasia
• Premature <34 weeks gestational age by history
• Having used leukotriene-modifying medication within 48 hours
• Having used theophylline within four weeks
• Unable to perform FEV1

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Forced Expiratory Volume in One Second (FEV1)

Secondary Outcome Measures

Name	Time	Method
Relapse Visit Rate
Hospitalization Rate

Trial Locations

Locations (1)

St. Louis Children's Hospital; 🇺🇸 St. Louis, Missouri, United States