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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00353184

Enrollment

Registered

2006-07-18

Start date

2001-09-30

Completion date

2005-02-28

Last updated

2010-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Acute, Asthma, Child, Pediatric, Emergency, Oral, Montelukast, Forced Expiratory Volume in One Second, FEV1

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.

Interventions

DRUGMontelukast 5-mg orally added to standard therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

6 Years to 14 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Forced Expiratory Volume in One Second (FEV1)	—

Secondary

Measure	Time frame
Hospitalization Rate	—
Relapse Visit Rate	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026