About: Genotype Tailored Treatment of Mild Symptomatic Acid Reflux in Children with Uncontrolled Asthma (GenARA): Rationale and Methods

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About: Genotype Tailored Treatment of Mild Symptomatic Acid Reflux in Children with Uncontrolled Asthma (GenARA): Rationale and Methods Goto Sponge NotDistinct Permalink

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
title	Genotype Tailored Treatment of Mild Symptomatic Acid Reflux in Children with Uncontrolled Asthma (GenARA): Rationale and Methods
Creator	Cobbaert, Marjan Franciosi, James Schmidt, Stephan Tang, Monica Blake, Kathryn Fischer, Bernard Hossain, Jobayer Lang, Jason Lima, John Mougey, Edward
source	Elsevier; Medline; PMC
abstract	Asthma causes enormous suffering and cost for children in the US and around the world [1-3]. Co-morbid gastroesophageal reflux disease (GERD) makes asthma management more difficult due to increased symptoms. Proton pump inhibitor (PPI) drugs are effective at improving to GERD symptoms, however they have demonstrated only modest and variable effects on asthma control in the setting of co-morbid GERD. Importantly, PPI metabolism and efficacy depend on CYP2C19 genotype. The Genotype Tailored Treatment of Symptomatic Acid Reflux in Children with Uncontrolled Asthma (GenARA) study is a randomized, double-blind, placebo-controlled trial to determine if genotype-tailored PPI dosing improves asthma symptoms among children with inadequately controlled asthma and GERD symptoms. This study has an innovative design to both assess the efficacy of genotype-tailored PPI dosing and perform pharmacokinetic modeling of the oral PPI Lansoprazole. Children ages 6-17 years old with clinician-diagnosed asthma and mild GERD symptoms will submit a saliva sample for CYP2C19 genotyping. Participants will undergo a two-step randomization to: (1) genotype-tailored versus conventional dosing of open-label oral lansoprazole for pharmacokinetic modeling, and (2) genotype-tailored lansoprazole daily versus placebo for 24 weeks to determine the effect of genotype-tailored PPI dosing on asthma control. Measures of asthma control, spirometry, and nasal washes during acute illnesses will be collected at 8-week intervals throughout the study. GenARA will better define the effects of CYP2C19 genotype on the dose response of lansoprazole in children and adolescents and assess if a novel dosing regimen improves GERD and asthma control.
has issue date	2019-03-01(xsd:dateTime)
bibo:doi	10.1016/j.cct.2019.01.009
bibo:pmid	30659924
has license	green-oa
sha1sum (hex)	b699e59df4a745526b2c3b358535eee106d8045d
schema:url	https://doi.org/10.1016/j.cct.2019.01.009
resource representing a document's title	Genotype Tailored Treatment of Mild Symptomatic Acid Reflux in Children with Uncontrolled Asthma (GenARA): Rationale and Methods
has PubMed Central identifier	PMC7039713
has PubMed identifier	30659924
schema:publication	Contemporary Clinical Trials
resource representing a document's body	covid:b699e59df4a745526b2c3b358535eee106d8045d#body_text
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