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

Condition(s) targeted: Asthma

Intervention: Montelukast 5-mg orally added to standard therapy (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Washington University School of Medicine

Official(s) and/or principal investigator(s):
Kyle A Nelson, MD, Principal Investigator, Affiliation: Physician in Division of Pediatric Emergency Medicine at Washington University School of Medicine in St. Louis
David M Jaffe, MD, Study Chair, Affiliation: Senior Advisor for Study, Division Director for Pediatric Emergency Medicine at Washington University School of Medicine

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.

Official title: Randomized Controlled Trial of Oral Montelukast Added to Standard Therapy for Acute Asthma Exacerbations in Children Age 6 to 14 Years

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Forced Expiratory Volume in One Second (FEV1)

Secondary outcome:

Hospitalization Rate

Relapse Visit Rate

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.

Minimum age: 6 Years. Maximum age: 14 Years. Gender(s): Both.

Criteria:

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

St. Louis Children's Hospital, St. Louis, Missouri 63110, United States

Starting date: September 2001
Ending date: May 2004
Last updated: July 17, 2006