Evaluation Montelukast in the Treatment of Status Asthmaticus

NCT ID: NCT01770899

Last Updated: 2013-02-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31

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.

Detailed 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.

Conditions

Status Asthmaticus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Montelukast

Montelukast 5mg capsules for 2-5 year old every 24h and 8mg capsules for 6-14 year olds every 24h.

Group Type: EXPERIMENTAL

Montelukast

Intervention Type: DRUG

Placebo

One placebo capsule given every 24h

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Gelatin capsule given every 24 hours

Interventions

Montelukast

Intervention Type: DRUG

Placebo

Gelatin capsule given every 24 hours

Intervention Type: DRUG

Other Intervention Names

Singulair

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Corrie Fletcher

OTHER

Sponsor Role: lead

Responsible Party

Corrie Fletcher

Pediatric Resident

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Corrie Fletcher, DO

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Advocate Children's Hospital Oak Lawn

Oak Lawn, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Corrie E Fletcher, DO

Role: CONTACT

corrie.fletcher@advocatehealth.com

708-684-1308

Luis Torero, MD

Role: CONTACT

luis.torero@advocatehealth.com

708-684-5685

Other Identifiers

5441

Identifier Type: -

Identifier Source: org_study_id