Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00116324
Status:
COMPLETED
Last Update Posted:
2021-05-18
First Post:
2005-06-28
Brief Title:
Predicting the Response to Montelukast by Genetic Variation in Asthmatics
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Predicting the Bronchoprotective Response to a Leukotriene Modifier by Genetic Polymorphism
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
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 examine a specific variation in the genetic code for an enzyme LTC4 synthase which plays an important role in the airway inflammation associated with asthma We hypothesize that asthmatic patients with this variant gene will have a better response to montelukast than patients with the wild type gene as measured by the ability of montelukast to protect against a hypertonic saline challenge
Detailed Description:
Multiple genetic polymorphisms in the leukotriene pathway have been described but their clinical relevance is unclear A single nucleotide polymorphism in the LTC4 synthase promoter region has been associated with increased LTC4 synthase mRNA and a trend toward improved bronchodilatory response to leukotriene modifiers in severe asthmatics This study will examine mild to moderate asthmatics with the variant gene and evaluate the bronchoprotective response of montelukast in a double-blind placebo-controlled cross-over fashion
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