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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00353184
• Other study ID #: WUSM HSC #01-0464
• Status: Terminated
• Phase: N/A
• First received: July 17, 2006
• Last updated: February 23, 2010
• Start date: September 2001
• Est. completion date: February 2005

Study information

• Verified date: February 2010
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: February 2005
• Est. primary completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 14 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Montelukast 5-mg orally added to standard therapy

Locations

Country	Name	City	State
United States	St. Louis Children's Hospital	St. Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	Ambulatory Pediatric Association, American Academy of Pediatrics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced Expiratory Volume in One Second (FEV1)
Secondary	Hospitalization Rate
Secondary	Relapse Visit Rate