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

• Status: Terminated
• Trial end date: 2005-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborators: Ambulatory Pediatric Association; American Academy of Pediatrics
• Treatments: Montelukast

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