Ignite Creation Date:
2024-05-06 @ 9:33 AM
Last Modification Date:
2024-10-26 @ 12:16 PM
Study NCT ID:
NCT03015610
Status:
COMPLETED
Last Update Posted:
2024-06-07
First Post:
2016-12-13
Brief Title:
Genotype-tailored Treatment of Symptomatic Acid-Reflux in Children With Uncontrolled Asthma
Sponsor:
Jason Lang MD MPH
Organization:
Duke University
Study Overview
Official Title:
Genotype-tailored Treatment of Symptomatic Acid-Reflux in Children With Uncontrolled Asthma
Status:
COMPLETED
Status Verified Date:
2024-06
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:
GenARA
Brief Summary:
This study will evaluate the effect of CYP2C19 and ABCB1 genes on pharmacokinetics of lansoprazole in children with mild gastroesophageal reflux GER and uncontrolled asthma It will determine if genotype-guided lansoprazole dosing of lansoprazole improves GER and asthma control
Detailed Description:
BACKGROUND Poorly controlled asthma especially in children remains a major public health problem Many children with poor asthma control experience gastroesophageal reflux GERD The effect of mild GERD on asthma remains controversial despite studies involving proton-pump inhibitors PPIs assessing their effect on asthma Past inconsistent findings regarding the effect of PPIs on asthma control may have resulted from ineffective dosing strategies of proton-pump inhibitors employed in these studies Drug levels and efficacy vary widely in the population and depend on genetics Dosing in children which adjusts for the gene CYP2C19 may improve efficacy and reduce side-effects leading to improved asthma control
HYPOTHESIS 1 The investigators hypothesize that genotype-tailored lansoprazole dosing will reduce asthma symptoms in children with mild symptoms of GERD compared to placebo 2 CYP2C19 and ABCB1 genetic variants influence the pharmacokinetics drug levels of lansoprazole as determined by population pharmacokinetic modeling
METHODS The investigators will conduct a 6-month randomized controlled trial comparing genotype-tailored lansoprazole dosing versus matched placebo in the control of asthma symptoms in 6-17 year olds with asthma and mild reflux All participants will have baseline pharmacokinetics analysis following a single genotype-tailored dose to assess the effects of CYP2C19 and ABCB1
IMPACT These results would be a major advance in the science of safe dosing of proton-pump inhibitors in children and for the management of the millions of children struggling with reflux and asthma
HYPOTHESIS 1 The investigators hypothesize that genotype-tailored lansoprazole dosing will reduce asthma symptoms in children with mild symptoms of GERD compared to placebo 2 CYP2C19 and ABCB1 genetic variants influence the pharmacokinetics drug levels of lansoprazole as determined by population pharmacokinetic modeling
METHODS The investigators will conduct a 6-month randomized controlled trial comparing genotype-tailored lansoprazole dosing versus matched placebo in the control of asthma symptoms in 6-17 year olds with asthma and mild reflux All participants will have baseline pharmacokinetics analysis following a single genotype-tailored dose to assess the effects of CYP2C19 and ABCB1
IMPACT These results would be a major advance in the science of safe dosing of proton-pump inhibitors in children and for the management of the millions of children struggling with reflux and asthma
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None