Symptom-driven ICS/LABA Therapy for Patients With Asthma Non-adherent to Daily Maintenance Inhalers (NCT05111262) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Symptom-driven ICS/LABA Therapy for Patients With Asthma Non-adherent to Daily Maintenance Inhalers
United States60 participantsStarted 2021-12-16
Plain-language summary
Inhaler nonadherence is a common problem that has been estimated to account for approximately 60% of all asthma-related hospitalizations. Unfortunately, prior interventions to improve inhaler nonadherence have shown a lack of long-term success. This study proposes to assess the problem of non-adherence using a D\&I research lens while testing a new inhaler approach to potentially ameliorate the detrimental consequences of maintenance inhaler nonadherence.
Who can participate
Age range12 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Able to understand and provide informed consent.
✓. Age 12-75 at the time of study enrollment.
✓. Provider diagnosed mild or moderate persistent asthma and prescribed maintenance ICS treatment and as needed SABA for at least 6 months prior to enrollment.
✓. 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.
✓. 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.
✓. iPhone or Android smartphone with an active data plan and willingness to use the Adherium device.
Exclusion criteria
✕. 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.
✕. 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 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.
What they're measuring
1
Adherence to inhaler strategy delineated using an electronic inhaler sensor
✕. Any clinically significant abnormalities on physical exam, laboratory testing, or baseline 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 two weeks after screening.