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

NCT ID: NCT00353184

Last Updated: 2010-02-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-09-30
• Study Completion Date: 2005-02-28

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Montelukast 5-mg orally added to standard therapy

Intervention Type: DRUG

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Academy of Pediatrics

OTHER

Sponsor Role: collaborator

Ambulatory Pediatric Association

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Washington University

Principal Investigators

Kyle A Nelson, MD

Role: PRINCIPAL_INVESTIGATOR

Physician in Division of Pediatric Emergency Medicine at Washington University School of Medicine in St. Louis

David M Jaffe, MD

Role: STUDY_CHAIR

Senior Advisor for Study, Division Director for Pediatric Emergency Medicine at Washington University School of Medicine

Locations

St. Louis Children's Hospital

St Louis, Missouri, United States

Countries

United States

Other Identifiers

WUSM HSC #01-0464

Identifier Type: -

Identifier Source: org_study_id