Title
Montelukast Added to Standard Therapy for Acute Asthma in Children Age 6-14 Years
Randomized Controlled Trial of Oral Montelukast Added to Standard Therapy for Acute Asthma Exacerbations in Children Age 6 to 14 Years
Phase
N/ALead Sponsor
Washington University in St. LouisStudy Type
InterventionalStatus
TerminatedIndication/Condition
AsthmaIntervention/Treatment
montelukast ...Study Participants
27Oral 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
