Phase
Condition
Asthma
Treatment
Symptom-driven budesonide/formoterol combination
Maintenance ICS and Symptom Driven SABA
Clinical Study ID
Ages 12-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Able to understand and provide informed consent.
Age 18-75 at the time of study enrollment.
Provider diagnosed mild or moderate persistent asthma and prescribed maintenance ICStreatment and as needed SABA for at least 6 months prior to enrollment.
Suboptimal adherence to prescribed maintenance ICS therapy defined as missing atleast expected 2 ICS refills in the prior 6 months based on examination of pharmacyrecords or a Medication Adherence Report Scale for Asthma (MARS-A) score <4.5.
An Asthma Control Test (ACT) score at enrollment greater than or equal to 12 butless than or equal to 20 indicating partially controlled or moderately uncontrolledasthma.
iPhone or Android smartphone with an active data plan and willingness to use theAdherium device.
Exclusion
Exclusion Criteria:
Relevant comorbid pulmonary diseases including, but not limited to a diagnosis ofchronic obstructive pulmonary disease (COPD), cystic fibrosis, or alpha 1anti-trypsin deficiency.
Current use of a biologic medication or investigational treatment for asthma.
History of asthma requiring ICU admission in the last year.
Unwillingness to use or pay for an inhaler that is compatible with the Adheriumsensor (fluticasone propionate or budesonide/formoterol). Of note, fluticasone andbudesonide/formoterol are formulary tier 1-2 for Missouri Medicaid and mostcommercial insurances and are believed to be equally or less expensive asalternative inhalers for most patients.
Any clinically significant abnormalities on physical exam, laboratory testing, orbaseline diagnostic testing that the study team believes will make the study unsafe.
Patients who do not complete at least 70% of the twice-daily texts during the twoweeks after screening.
Study Design
Study Description
Connect with a study center
Washington University in St. Louis School of Medicine
Saint Louis, Missouri 63110
United StatesActive - Recruiting
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