Evaluation Montelukast in the Treatment of Status Asthmaticus

Status Recruiting

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.

Clinical Trial 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. ;

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

Clinical Trial Details

NCT number	NCT01770899
Study type	Interventional
Source	Advocate Center for Pediatric Research
Contact	Corrie E Fletcher, DO
Phone	708-684-1308
Email	corrie.fletcher@advocatehealth.com
Status	Recruiting
Phase	N/A
Start date	January 2013

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02872597` - Phase I, Placebo-Controlled, Blinded Pilot Study of Ipratropium in Children Admitted to the ICU With Status Asthmaticus	Phase 1
Terminated	`NCT02966184` - Comparison of Albuterol for Status Asthmaticus	Phase 4
Enrolling by invitation	`NCT00750568` - Intravenous Terbutaline in Severe Status Asthmaticus	N/A
Completed	`NCT00124995` - Trial of Terbutaline for the Treatment of Status Asthmaticus in Children	Phase 4
Recruiting	`NCT05819541` - Treating Exacerbations of Asthma With Oral Montelukast in Children	Phase 2
Completed	`NCT01524198` - The Use of Inhaled Corticosteroids in the Treatment of Asthma is Children in the Emergency Room	Phase 2/Phase 3
Terminated	`NCT02780479` - Steroids in Children Hospitalized With Asthma	Phase 4
Withdrawn	`NCT01403428` - Non Invasive Positive Pressure Ventilation in Status Asthmaticus	Phase 2
Terminated	`NCT00683449` - Study Evaluating the Safety and Effects of MN-221 in Subjects Experiencing an Acute Exacerbation of Asthma	Phase 2
Withdrawn	`NCT03219736` - NiPPV in the Treatment of Acute Asthma Exacerbations	N/A
Completed	`NCT00722020` - HFCWO in Hospitalized Asthmatic Children	N/A
Withdrawn	`NCT03338205` - The Role of Ketamine as an Adjuvant Therapy for Children With Acute Status Asthmaticus	Phase 3
Completed	`NCT02302261` - Pleth Variability and Asthma Severity in Children	N/A
Withdrawn	`NCT01188473` - Early Noninvasive Positive Pressure Ventilation in Children With Status Asthmaticus	Phase 1
Withdrawn	`NCT04656587` - BPAP in Pediatric Asthma Pilot Study	N/A
Completed	`NCT04929626` - Different Doses of Nebulized Magnesium Sulphate in Status Asthmaticus	Phase 1
Completed	`NCT00623688` - Effectiveness and Cost Study Comparing Two Ways to Deliver Albuterol for the Treatment of Asthma in the Hospital	N/A
Recruiting	`NCT00494572` - Montelukast With Status Asthmaticus, Ages 6-18	Phase 2/Phase 3
Recruiting	`NCT00491790` - Montelukast With Status Asthmaticus, Ages 2-5	Phase 2/Phase 3
Completed	`NCT00279786` - B2-Adrenergic Receptor Polymorphisms

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.