Genotype-tailored Treatment of Symptomatic Acid-Reflux in Children With Uncontrolled Asthma (NCT03015610) | Clinical Trial Compass
CompletedPhase 3
Genotype-tailored Treatment of Symptomatic Acid-Reflux in Children With Uncontrolled Asthma
United States41 participantsStarted 2017-10-31
Plain-language 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.
Who can participate
Age range6 Years – 17 Years
SexALL
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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;
* Dail…
What they're measuring
1
Change in Asthma Control Questionnaire (ACQ) From Screening Through Week 26