Results of the interim analysis suggested no significant diff between study groups.

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.

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