Clinical trial NCT00353184: Montelukast Added to Standard Therapy for Acute Asthma in Children Age 6-14 Years
Official title: Randomized Controlled Trial of Oral Montelukast Added to Standard Therapy for Acute Asthma Exacerbations in Children Age 6 to 14 Years
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Asthma
Keywords: Acute
Asthma
Child
Pediatric
Emergency
Oral
Montelukast
Forced Expiratory Volume in One Second
FEV1
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: American Academy of Pediatrics
name: Ambulatory Pediatric Association
First posted: 2006-07-18
Enrollment: 27
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Forced Expiratory Volume in One Second (FEV1)
Secondary outcomes:
measure: Hospitalization Rate
measure: Relapse Visit Rate
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
Study officials:
affiliation: Physician in Division of Pediatric Emergency Medicine at Washington University School of Medicine in St. Louis
name: Kyle A Nelson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Senior Advisor for Study, Division Director for Pediatric Emergency Medicine at Washington University School of Medicine
name: David M Jaffe, MD
role: STUDY_CHAIR
References: