Back to resultsMontelukast Added to Standard Therapy for Acute Asthma in Children Age 6-14 Years
Primary Purpose
Asthma
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Montelukast 5-mg orally added to standard therapy
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Acute, Asthma, Child, Pediatric, Emergency, Oral, Montelukast, Forced Expiratory Volume in One Second, FEV1
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
Sites / Locations
- St. Louis Children's Hospital
Outcomes
Primary Outcome Measures
Forced Expiratory Volume in One Second (FEV1)
Secondary Outcome Measures
Hospitalization Rate
Relapse Visit Rate
Full Information
NCT ID
NCT00353184
First Posted
July 17, 2006
Last Updated
February 23, 2010
Sponsor
Washington University School of Medicine
Collaborators
American Academy of Pediatrics, Ambulatory Pediatric Association
1. Study Identification
Unique Protocol Identification Number
NCT00353184
Brief Title
Montelukast Added to Standard Therapy for Acute Asthma in Children Age 6-14 Years
Official Title
Randomized Controlled Trial of Oral Montelukast Added to Standard Therapy for Acute Asthma Exacerbations in Children Age 6 to 14 Years
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Terminated
Why Stopped
Results of the interim analysis suggested no significant diff between study groups.
Study Start Date
September 2001 (undefined)
Primary Completion Date
October 2004 (Actual)
Study Completion Date
February 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Washington University School of Medicine
Collaborators
American Academy of Pediatrics, Ambulatory Pediatric Association
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Acute, Asthma, Child, Pediatric, Emergency, Oral, Montelukast, Forced Expiratory Volume in One Second, FEV1
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Montelukast 5-mg orally added to standard therapy
Primary Outcome Measure Information:
Title
Forced Expiratory Volume in One Second (FEV1)
Secondary Outcome Measure Information:
Title
Hospitalization Rate
Title
Relapse Visit Rate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyle A Nelson, MD
Organizational Affiliation
Physician in Division of Pediatric Emergency Medicine at Washington University School of Medicine in St. Louis
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David M Jaffe, MD
Organizational Affiliation
Senior Advisor for Study, Division Director for Pediatric Emergency Medicine at Washington University School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
St. Louis Children's Hospital
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
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Montelukast Added to Standard Therapy for Acute Asthma in Children Age 6-14 Years
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