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

Launched by WASHINGTON UNIVERSITY SCHOOL OF MEDICINE · Jan 9, 2023

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ClinConnect Summary

This clinical trial is studying a new approach to help adolescents and adults with asthma who have trouble sticking to their prescribed inhaler treatments. Inhaler nonadherence is a major issue, leading to many asthma-related hospital visits. The researchers want to see if using a new inhaler method can improve the situation and help patients manage their asthma better. They are looking for participants aged 18 to 75 who have been diagnosed with mild to moderate asthma and have not been consistently using their maintenance inhalers. To qualify, participants should have missed at least two inhaler refills in the last six months and have a specific asthma control score.

If you decide to join the trial, you will be using a special inhaler that works with a device to track your usage. You will also receive reminders through text messages to help you stay on track with your medication. This study is currently recruiting participants, so if you or someone you know fits the eligibility criteria and is interested, it could be a great opportunity to contribute to research that may improve asthma care for others. Remember, it's essential to have a smartphone and be willing to use the tracking device as part of the study.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Able to understand and provide informed consent.
• • 2. Age 18-75 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.
• • 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.