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Genotype tailored treatment of mild symptomatic acid reflux in children with uncontrolled asthma (GenARA): Rationale

Monica Tang1, Kathryn V Blake2, John J Lima2

  • 1Division of Allergy/Immunology and Pulmonary Medicine, Duke University School of Medicine, Duke Children's Hospital and Health Center, Durham, NC, United States.

Contemporary Clinical Trials
|January 20, 2019
PubMed

Insights

This study investigates if tailoring proton pump inhibitor (PPI) doses based on CYP2C19 genotype improves asthma control in children with GERD. Genotype-tailored PPI treatment may offer a more effective approach for managing these co-occurring conditions.

Area of Science:

  • Pediatric Pulmonology
  • Clinical Pharmacology
  • Gastroenterology

Background:

  • Asthma and gastroesophageal reflux disease (GERD) are common in children, with GERD complicating asthma management.
  • Proton pump inhibitors (PPIs) improve GERD but show variable effects on asthma control.
  • PPI efficacy and metabolism are influenced by CYP2C19 genetic variations.

Purpose of the Study:

  • To evaluate if genotype-tailored PPI dosing improves asthma control in children with inadequately controlled asthma and GERD.
  • To conduct pharmacokinetic modeling of lansoprazole in pediatric patients.
  • To assess the impact of CYP2C19 genotype on lansoprazole dose-response.

Main Methods:

  • The Genotype Tailored Treatment of Symptomatic Acid Reflux in Children with Uncontrolled Asthma (GenARA) study is a randomized, double-blind, placebo-controlled trial.
  • Participants (6-17 years) with asthma and GERD symptoms undergo CYP2C19 genotyping.
  • A two-step randomization assigns participants to genotype-tailored vs. conventional lansoprazole dosing for pharmacokinetics, and genotype-tailored lansoprazole vs. placebo for 24 weeks to assess asthma control.

Main Results:

  • Study is ongoing; results are pending.
  • Pharmacokinetic modeling will define lansoprazole dose-response based on CYP2C19 genotype.
  • Asthma control, spirometry, and nasal wash data will be collected at 8-week intervals.

Conclusions:

  • GenARA aims to clarify the role of CYP2C19 genotype in lansoprazole pharmacokinetics and efficacy in children.
  • This research may lead to personalized medicine approaches for managing pediatric asthma and GERD.
  • Determining if genotype-tailored PPI dosing improves both GERD and asthma control is the primary objective.

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