Evaluation Montelukast in the Treatment of Status Asthmaticus

Status Asthmaticus Clinical Trial

Official title:

A Prospective Analysis of the Use of Oral Montelukast in Children With Status Asthmaticus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01770899
• Other study ID #: 5441
• Status: Recruiting
• Phase: N/A
• First received: January 15, 2013
• Last updated: February 22, 2013
• Start date: January 2013

Study information

• Verified date: February 2013
• Source: Advocate Center for Pediatric Research
• Contact: Corrie E Fletcher, DO
• Phone: 708-684-1308
• Email: corrie.fletcher[@]advocatehealth.com
• Is FDA regulated: No
• Health authority: United States: Advocate Health Care Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 14 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Status Asthmaticus

Intervention

Drug:
• Montelukast

• Placebo
Gelatin capsule given every 24 hours

Locations

Country	Name	City	State
United States	Advocate Children's Hospital Oak Lawn	Oak Lawn	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Corrie Fletcher

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No