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

• Status: Recruiting
• Trial end date: 2022-01-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jason Lang, M.D., M.P.H.
• Collaborators: Nemours Children's Clinic; Thrasher Research Fund
• Treatments: Dexlansoprazole; Lansoprazole

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;

• Plan for family to move from study location within the next 6 months.