Symptom-driven ICS/LABA Therapy for Patients With Asthma Non-adherent to Daily Maintenance Inhalers

Launched by WASHINGTON UNIVERSITY SCHOOL OF MEDICINE · Oct 27, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help people with asthma who struggle to use their daily inhalers as prescribed. Many asthma patients miss taking their medication, which can lead to serious health issues and hospital visits. The study aims to understand why some patients don’t follow their treatment plans and to test a new inhaler method that could help them manage their asthma more effectively.

To participate, you should be between 12 and 75 years old, have mild to moderate asthma, and have not been taking your prescribed daily inhaler regularly. You'll need to have a smartphone and be open to using a special device that tracks your inhaler usage. If you join, you can expect to receive support and guidance throughout the trial to help improve your asthma management. It's important to remember that this study is focused on finding better solutions for patients like you who face challenges with their inhaler use.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Able to understand and provide informed consent.
• • 2. Age 12-75 at the time of study enrollment.
• • 3. Provider diagnosed mild or moderate persistent asthma and prescribed maintenance ICS treatment and as needed SABA for at least 6 months prior to enrollment.
• • 4. Suboptimal adherence to prescribed maintenance ICS therapy defined as missing at least expected 2 ICS refills in the prior 6 months based on examination of pharmacy records or a Medication Adherence Report Scale for Asthma (MARS-A) score \<4.5.
• • 5. An Asthma Control Test (ACT) score at enrollment greater than or equal to 12 but less than or equal to 20 indicating partially controlled or moderately uncontrolled asthma. Adolescents age 12-17 with an ACT score 12-25 will be considered eligible.
• • 6. iPhone or Android smartphone with an active data plan and willingness to use the Adherium device.
• Exclusion Criteria:
• • 1. Relevant comorbid pulmonary diseases including, but not limited to a diagnosis of chronic obstructive pulmonary disease (COPD), cystic fibrosis, or alpha 1 anti-trypsin deficiency.
• • 2. Current use of a biologic medication or investigational treatment for asthma.
• • 3. History of asthma requiring ICU admission in the last year.
• • 4. Unwillingness to use or pay for an inhaler that is compatible with the Adherium sensor (fluticasone propionate or budesonide/formoterol). Of note, fluticasone and budesonide/formoterol are formulary tier 1-2 for Missouri Medicaid and most commercial insurances and are believed to be equally or less expensive as alternative inhalers for most patients.
• • 5. Any clinically significant abnormalities on physical exam, laboratory testing, or baseline diagnostic testing that the study team believes will make the study unsafe.
• • 6. Patients who do not complete at least 70% of the twice-daily texts during the two weeks after screening.