Evidence map›Paper›PMID 30659924›Full record

ArticleContemporary clinical trials2019

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

Monica Tang, Kathryn V Blake, John J Lima, Edward B Mougey, James Franciosi, Stephan Schmidt, Md Jobayer Hossain, Marjan Cobbaert, Bernard M Fischer, Jason E Lang

Abstract readClinical Trial Protocol
In one paragraph

Article in Contemporary clinical trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
1.3field-weighted citation impact, top 20% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Review
  4. Association betweenFrontiers in pharmacology · 2025
    Review
  5. Review
  6. Review
  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 5 institutions in 1 country.

Monica TangDivision of Allergy/Immunology and Pulmonary Medicine, Duke University School of Medicine, Duke Children's Hospital and Health Center, Durham, NC, United States.
Kathryn V BlakeCenter for Pharmacogenomics and Translational Research, Nemours Children's Health System, Jacksonville, FL, United States.
John J LimaCenter for Pharmacogenomics and Translational Research, Nemours Children's Health System, Jacksonville, FL, United States.
Edward B MougeyCenter for Pharmacogenomics and Translational Research, Nemours Children's Health System, Jacksonville, FL, United States.
James FranciosiDepartment of Pediatrics, Nemours Children's Hospital, Nemours Children's Health System, Orlando, FL, United States.
Stephan SchmidtCenter for Pharmacometrics and Systems Pharmacology, College of Pharmacy, University of Florida, Orlando, FL, United States.
Md Jobayer HossainDepartment of Biomedical Research, Nemours/Alfred I. DuPont Hospital for Children, Wilmington, DE, United States.
Marjan CobbaertDepartment of Pharmacometrics, Duke Clinical Research Institute, Durham, NC, United States.
Bernard M FischerDivision of Allergy/Immunology and Pulmonary Medicine, Duke University School of Medicine, Duke Children's Hospital and Health Center, Durham, NC, United States.
Jason E LangDivision of Allergy/Immunology and Pulmonary Medicine, Duke University School of Medicine, Duke Children's Hospital and Health Center, Durham, NC, United States. Electronic address: jason.lang@duke.org.
Nemours Children's Health System · USDuke University · USAlfred I. duPont Hospital for Children · USClinical Research Institute · USUniversity of Florida · US

Funding

RESEARCH TRAINING IN ALLERGY AND CLINICAL IMMUNOLOGYT32AI007062 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI David B. Peden, John W. Sleasman · 1985 to 2026
$6.1M
NIAID NIH HHS T32 AI007062
6 · The paper itself

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.

Indexed as

AsthmaGastroesophageal RefluxLansoprazolePrecision MedicineProton Pump InhibitorsAdolescentBody Weights and MeasuresChildComorbidityCytochrome P-450 CYP2C19Double-Blind MethodFemaleGenotypeHumansMaleModels, BiologicalCYP2C19 protein, humanCytochrome P-450 CYP2C19LansoprazoleProton Pump Inhibitors

Identifiers

PMID30659924
PMCPMC7039713
OpenAlexW2908896005

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.