NCT00491790

Montelukast With Status Asthmaticus, Ages 2-5

• 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: 2 Years – 5 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 2-5 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 from 2-5 years old who are in the PICU. Children who meet eligibility requirements will be randomized to receive a rapid-dissolving oral dose of montelukast or placebo. Once enrolled, a baseline modified Wood's-Downes clinical asthma severity score will be recorded pre and post completion of a standard nebulized albuterol treatment of 0.15 mg/kg/dose (min2.5mg/dose). Patients who are able will have FEV1 measurements obtained at predetermined intervals for determination of clinical asthma severity score. 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	Montelukast 4 mg rapid dissolving granules in sterile water given orally once
OTHER	Sterile water	Sterile water

Timeline

• Start date: 2006-12-01
• Primary completion: 2010-01-01
• Completion: 2010-10-01
• First posted: 2007-06-26
• Last updated: 2008-12-16

Locations

1 site across 1 country: United States