Evaluation Montelukast in the Treatment of Status Asthmaticus

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Advocate Center for Pediatric Research
Sponsor:
Information provided by (Responsible Party):
Corrie Fletcher, Advocate Center for Pediatric Research
ClinicalTrials.gov Identifier:
NCT01770899
First received: January 15, 2013
Last updated: February 22, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Status Asthmaticus
Drug: Montelukast
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective Analysis of the Use of Oral Montelukast in Children With Status Asthmaticus

Resource links provided by NLM:


Further study details as provided by Advocate Center for Pediatric Research:

Primary Outcome Measures:
  • Improvement of pediatric asthma score [ Time Frame: Hourly during the length of the patient's pediatric ICU hospitalization for status asthmaticus ] [ Designated as safety issue: No ]
    Measurement of pediatric asthma score hourly from admission assessing for time to improvement of score, an average length of stay predicted 2-4 days.


Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Montelukast
Montelukast 5mg capsules for 2-5 year old every 24h and 8mg capsules for 6-14 year olds every 24h.
Drug: Montelukast
Other Name: Singulair
Placebo Comparator: Placebo
One placebo capsule given every 24h
Drug: Placebo
Gelatin capsule given every 24 hours

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.

  Eligibility

Ages Eligible for Study:   2 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01770899

Contacts
Contact: Corrie E Fletcher, DO 708-684-1308 corrie.fletcher@advocatehealth.com
Contact: Luis Torero, MD 708-684‑5685 luis.torero@advocatehealth.com

Locations
United States, Illinois
Advocate Children's Hospital Oak Lawn Recruiting
Oak Lawn, Illinois, United States, 60453
Principal Investigator: Corrie Fletcher, DO         
Sponsors and Collaborators
Corrie Fletcher
Investigators
Principal Investigator: Corrie Fletcher, DO Advocate Health Care
  More Information

No publications provided

Responsible Party: Corrie Fletcher, Pediatric Resident, Advocate Center for Pediatric Research
ClinicalTrials.gov Identifier: NCT01770899     History of Changes
Other Study ID Numbers: 5441
Study First Received: January 15, 2013
Last Updated: February 22, 2013
Health Authority: United States: Advocate Health Care Institutional Review Board

Keywords provided by Advocate Center for Pediatric Research:
Montelukast
Singulair
status asthmaticus

Additional relevant MeSH terms:
Status Asthmaticus
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Montelukast
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 01, 2014