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Genotype-tailored Treatment of Symptomatic Acid-Reflux in Children With Uncontrolled Asthma

NCT03015610 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2025-09-09

Study results available
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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.

Conditions

  • Asthma
  • Gastroesophageal Reflux

Interventions

DRUG

commercially available lansoprazole

these participants will receive a one-time dose of lansoprazole followed by PK analysis and then once daily lansoprazole for 24 weeks

DRUG

matched placebo

these participants will receive a one-time dose of lansoprazole followed by PK analysis and then once daily placebo for 24 weeks

Sponsors & Collaborators

  • Thrasher Research Fund

    collaborator OTHER

  • Nemours Children's Clinic

    collaborator OTHER

  • Jason Lang, M.D., M.P.H.

    lead OTHER

Principal Investigators

  • Jason E Lang, MD, MPH · Duke Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-31
Primary Completion
2024-01-18
Completion
2024-01-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03015610 on ClinicalTrials.gov