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GenARA: A study for Children with Asthma and Acid-Reflux - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if the daily dosing of the study drug, Lansoprazole, improves with asthma symptoms based on your child's genotype (metabolism).

What is the Condition Being Studied?

Poorly controlled Asthma in Children with GERD

Who Can Participate in the Study?

Children who:
- Are aged 6- 17 years old
- Are diagnosed with poorly controlled asthma
- Have GERD symptoms
- Are taking inhaled corticosteroid greater than twice a week

Age Group
Children

What is Involved?

If you choose to join this study, your child will:
- Be put into one of the 2 groups (like the flip of a coin), you would either get:
-- The study drug, liquid Lansoprazole by mouth
OR
-- the placebo (inactive drug)
- Have two blood draws
- Have nasal samples
- Complete a daily diary card
- Have spirometry testing
- Complete questionnaires in clinic and the phone
- Have 5 clinic visits and 3 telephone calls
- Be involved in this study for 26 weeks

Study Details

Full Title
Genotype-tailored Treatment of Symptomatic Acid-Reflux in Children with Uncontrolled Asthma
Principal Investigator
Protocol Number
IRB:PRO00079073
NCT:NCT03015610
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698