Evaluation Montelukast in the Treatment of Status Asthmaticus
A Prospective Analysis of the Use of Oral Montelukast in Children With Status Asthmaticus
1 other identifier
interventional
100
1 country
1
Brief Summary
The purpose of this study is to evaluate the effectiveness of oral montelukast (Singulair) given with other standard asthma medications and treatments in the treatment of children with status asthmaticus. Status asthmaticus is an acute asthma attack that does not respond to standard intermittent treatments but requires a continuous medication to aid in breathing. While new medications have been used to better manage chronic asthma, acute asthma exacerbations continue to be a significant cause of hospitalization and even death in children. Oral montelukast is a very safe medication that is used to manage chronic asthma in children, but it has not been studied for use in status asthmaticus. If oral montelukast, given with other standard therapies, can reduce the treatment length associated with severe, acute asthma exacerbations in children, it could potentially improve both the morbidity and burden of pediatric asthma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 15, 2013
CompletedFirst Posted
Study publicly available on registry
January 18, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedFebruary 25, 2013
February 1, 2013
11 months
January 15, 2013
February 22, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement of pediatric asthma score
Measurement of pediatric asthma score hourly from admission assessing for time to improvement of score, an average length of stay predicted 2-4 days.
Hourly during the length of the patient's pediatric ICU hospitalization for status asthmaticus
Study Arms (2)
Montelukast
EXPERIMENTALMontelukast 5mg capsules for 2-5 year old every 24h and 8mg capsules for 6-14 year olds every 24h.
Placebo
PLACEBO COMPARATOROne placebo capsule given every 24h
Interventions
Eligibility Criteria
You may qualify if:
- Between ages 2-148 years
- Requiring PICU admission for status asthmaticus
- Able to take oral medication
- Pediatric asthma score \> 8 on admission
You may not qualify if:
- Intubated patients or other patients unable to take medications by mouth secondary to anatomic or pre-existing craniofacial issues
- Patients already on montelukast as their controller medication
- Patients with a known allergy to montelukast
- Any patient with phenylketonuria (PKU)
- Any patient currently on treatment with rifampin, fluconazole, or Phenobarbital medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Corrie Fletcherlead
Study Sites (1)
Advocate Children's Hospital Oak Lawn
Oak Lawn, Illinois, 60453, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Corrie Fletcher, DO
Wake Forest University Health Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Pediatric Resident
Study Record Dates
First Submitted
January 15, 2013
First Posted
January 18, 2013
Study Start
January 1, 2013
Primary Completion
December 1, 2013
Last Updated
February 25, 2013
Record last verified: 2013-02