NCT00494572

Montelukast With Status Asthmaticus, Ages 6-18

Pharmacokinetics and Pharmacodynamics of Montelukast in Children, Ages 6 Through 18 Years Old, With Status Asthmaticus Unresponsive to Conventional Treatment

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NIH
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if montelukast, in addition to standard treatment is helpful in treating patients ages 6-18 who are in the hospital because of status asthmaticus.

Detailed description

This is a prospective study of montelukast efficacy in addition to standard treatment of status asthmaticus in children who are in the PICU. The study will be stratified in 2 groups: children 6-12 years of age and adolescents 13-18 years of age. Children who meet eligibility requirements will be randomized to receive a rapid-dissolving oral dose of montelukast or placebo. Participants will be given a physical exam, have FEV1 measurements and clinical asthma scores recorded pre- and post- completion of a nebulized albuterol treatment of 0.1 mg/kg/dose (min 2.5 mg/dose). Blood samples for PK analysis will be collected prior to study drug administration and at predetermined time intervals to determine the plasma level of montelukast. In addition, a blood sample will be obtained for genetic study of polymorphisms of CYP3A4, CYP3A5, and CYP2C9.

Conditions

• Status Asthmaticus
• Asthma

Interventions

Type	Name	Description
DRUG	Montelukast	10 mg rapid dissolving granule in sterile water orally once
OTHER	sterile water	sterile water

Timeline

• Start date: 2006-12-01
• Primary completion: 2010-01-01
• Completion: 2010-10-01
• First posted: 2007-06-29
• Last updated: 2008-12-16

Locations

1 site across 1 country: United States