Evaluation Montelukast in the Treatment of Status Asthmaticus
| Status: | Recruiting |
|---|---|
| Conditions: | Asthma |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 2 - 14 |
| Updated: | 4/2/2016 |
| Start Date: | January 2013 |
| Contact: | Corrie E Fletcher, DO |
| Email: | corrie.fletcher@advocatehealth.com |
| Phone: | 708-684-1308 |
A Prospective Analysis of the Use of Oral Montelukast in Children With Status Asthmaticus
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.
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.
While new medications have been used to better manage chronic asthma, acute exacerbations
continue to be a significant cause of pediatric morbidity and mortality. Montelukast holds
an established role in the pediatric outpatient management of asthma and while two promising
studies in adults have demonstrated its potential use as an adjunctive therapy for acute
exacerbations, its similar use in pediatrics has yet to be established. This pilot study is
designed as a prospective, double blinded, randomized, controlled, clinical trial comparing
the use of oral montelukast plus standard of care vs. standard of care alone in children
admitted for status asthmaticus to the pediatric intensive care unit (PICU). The primary
outcome the investigators are interested in is the time to reach a Modified Pediatric Asthma
Score (PAS) of < 5, which, per the clinical protocol for the treatment of status
asthmaticus, is the time when patients are able to come off continuous bronchodilator
therapy. If oral montelukast, given with other standard therapies, can reduce the treatment,
emotional, and financial burden (e.g., shortened intensive care stay) associated with
severe, acute asthma exacerbations in children, it would provide a significant therapeutic
advantage, potentially improving both the morbidity and burden of pediatric asthma.
continue to be a significant cause of pediatric morbidity and mortality. Montelukast holds
an established role in the pediatric outpatient management of asthma and while two promising
studies in adults have demonstrated its potential use as an adjunctive therapy for acute
exacerbations, its similar use in pediatrics has yet to be established. This pilot study is
designed as a prospective, double blinded, randomized, controlled, clinical trial comparing
the use of oral montelukast plus standard of care vs. standard of care alone in children
admitted for status asthmaticus to the pediatric intensive care unit (PICU). The primary
outcome the investigators are interested in is the time to reach a Modified Pediatric Asthma
Score (PAS) of < 5, which, per the clinical protocol for the treatment of status
asthmaticus, is the time when patients are able to come off continuous bronchodilator
therapy. If oral montelukast, given with other standard therapies, can reduce the treatment,
emotional, and financial burden (e.g., shortened intensive care stay) associated with
severe, acute asthma exacerbations in children, it would provide a significant therapeutic
advantage, potentially improving both the morbidity and burden of pediatric asthma.
Inclusion criteria:
- Between ages 2-148 years
- Requiring PICU admission for status asthmaticus
- Able to take oral medication
- Pediatric asthma score > 8 on admission
Exclusion criteria:
- 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
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