Evaluation Montelukast in the Treatment of Status Asthmaticus

C

Corrie Fletcher

Status

Unknown

Conditions

Status Asthmaticus

Treatments

Drug: Montelukast
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01770899
5441

Details and patient eligibility

About

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.

Full description

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.

Enrollment

100 estimated patients

Sex

All

Ages

2 to 14 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

100 participants in 2 patient groups, including a placebo group

Montelukast
Experimental group
Description:
Montelukast 5mg capsules for 2-5 year old every 24h and 8mg capsules for 6-14 year olds every 24h.
Treatment:
Drug: Montelukast
Placebo
Placebo Comparator group
Description:
One placebo capsule given every 24h
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Central trial contact

Corrie E Fletcher, DO; Luis Torero, MD

Data sourced from clinicaltrials.gov

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