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

NCT03015610 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: Pro00079073
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

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.

Conditions

Asthma; Gastroesophageal Reflux

Keywords

Personalized Medicine; CYP2C19; Lansoprazole; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Change in Asthma Control Questionnaire (ACQ) From Screening Through Week 26

  The ACQ considers a broad set of common indicators of asthma control including use of bronchodilators, cough, nocturnal symptoms, level of activity, and pulmonary function. Scores range between 0 (totally controlled) and 6 (severely uncontrolled). Reported is the change from week 0 to week 26; a negative change value indicates an improvement in asthma control.

  Week 0 (baseline) to week 26

Secondary Outcomes (6)

• Change in GERD (Gastroesophageal Reflux Disease) Symptom Assessment Questionnaire Score (GSAS) From Screening Through Week 26

  Week 0 (baseline) to week 26

• Change in Asthma Symptom Utility Index (ASUI) From Screening Through Week 26

  Week 0 (baseline) to week 26

• Annualized Rate of Asthma Exacerbations

  Up to week 26

• Annualized Rate of Episodes of Poor Asthma Control (EPAC)

  Up to week 26

• Annualized Rate of Respiratory Tract Infection (RTI)

  Up to week 26

Study Arms (2)

Placebo

PLACEBO COMPARATOR

participants will receive oral blinded matched placebo once daily

Drug: matched placebo

Genotype-guided Lansoprazole

EXPERIMENTAL

participants will receive oral blinded commercially available lansoprazole once daily with a dose appropriate for the participant's metabolizer phenotype

Drug: commercially available lansoprazole

Interventions

commercially available lansoprazole DRUG

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

Also known as: once daily

Genotype-guided Lansoprazole

matched placebo DRUG

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

Also known as: once daily

Placebo

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age: 6-17 year olds with documented clinician-diagnosed asthma
• Evidence of recent uncontrolled asthma (must meet at least one of the following). This convention for defining poorly-controlled asthma has been successfully used in a large pediatric trial.
• ACQ \> 1.2
• Use of short-acting beta-agonist for asthma symptoms twice/week or more on average over the past month
• Nocturnal awakenings with asthma symptoms more than once per week on average over the last month
• Two or more emergency department visits, unscheduled provider visits, prednisone courses or hospitalizations for asthma in the past 12 months
• Currently on stable dose of daily inhaled corticosteroid medication (ICS) for asthma control equivalent to 88mcg of fluticasone or greater for at least 6 weeks from the time of enrollment. Participant must be on National Asthma Education and Prevention Program (NAEPP) controller step 2, 3 or 4.
• Currently with mild GERD symptoms reported at V1 defined by a score on the Pediatric GERD Symptom Assessment Score greater than 15 and less than 80. GSAS ranges from 0 to \>440.

You may not qualify if:

• Taking daily CYP2C19 substrates, inducers or inhibitors medication
• Past or current history of moderate-severe GERD or related disorders (erosive esophagitis, peptic ulcer disease, eosinophilic esophagitis) which in the opinion of the pediatric gastroenterology safety specialist/study physician requires treatment with acid-blocking agents;
• Daily use of a PPI for more than 4 consecutive weeks in the past 6 months;
• previous intubation for asthma,
• admission to intensive care unit for more than 24 hours for asthma in the past year,
• Previous surgery involving the esophagus or stomach (anti-reflux surgery, peptic ulcer surgery, trachea-esophageal fistula repair);
• Forced expiratory volume in 1 second (FEV1) \< 60% of predicted at enrollment;
• Any major chronic illness that would interfere with participation in the intervention or completion of the study procedures;
• History of phenylketonuria (PKU);
• Medication use: treatment of GERD symptoms with over-the-counter antacids 4 days/week or more on average over past month;
• Theophylline preparations, azoles, anti-coagulants, insulin for Type 1 diabetes, digitalis, oral iron supplements when administered for iron deficiency within 1 month;
• Any investigational drugs within the past 2 months;
• Drug Allergies: previous allergic reaction from lansoprazole or other proton pump inhibitor medication or adverse reaction to aspartame;
• Inability to complete baseline measurements in a satisfactory manner according to the judgment of the research coordinator or site PI;
• Less than 75% completion of daily diary for asthma symptoms, SABA use and ICS medication adherence during the run-in period;

Sponsors & Collaborators

• Jason Lang, M.D., M.P.H.: lead
• Thrasher Research Fund: collaborator
• Nemours Children's Clinic: collaborator

Study Sites (2)

Nemours Children's Specialty Care

Jacksonville, Florida, 32207, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Asthma; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Jason Lang, MD
• Organization: Duke University

jason.lang@duke.edu

919-684-3364

Study Officials

• Jason E Lang, MD, MPH

  Duke Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: January 10, 2017
• Study Start: October 31, 2017
• Primary Completion: January 18, 2024
• Study Completion: January 18, 2024
• Last Updated: September 9, 2025
• Results First Posted: September 9, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)