Status:
TERMINATED
Montelukast Added to Standard Therapy for Acute Asthma in Children Age 6-14 Years
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
American Academy of Pediatrics
Ambulatory Pediatric Association
Conditions:
Asthma
Eligibility:
All Genders
6-14 years
Phase:
NA
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 result...
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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2005
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00353184
Start Date
September 1 2001
End Date
February 1 2005
Last Update
February 24 2010
Active Locations (1)
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1
St. Louis Children's Hospital
St Louis, Missouri, United States, 63110