Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00494572
Status:
UNKNOWN
Last Update Posted:
2008-12-16
First Post:
2007-06-28
Brief Title:
Montelukast With Status Asthmaticus Ages 6-18
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Pharmacokinetics and Pharmacodynamics of Montelukast in Children Ages 6 Through 18 Years Old With Status Asthmaticus Unresponsive to Conventional Treatment
Status:
UNKNOWN
Status Verified Date:
2008-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 01 mgkgdose min 25 mgdose 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None