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

• Status: Not yet recruiting
• Trial end date: 2023-03-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborator: National Institutes of Health (NIH)
• Treatments: Budesonide

Criteria

Inclusion Criteria:

• Able to understand and provide informed consent.

• Age 18-75 at the time of study enrollment.

• Provider diagnosed mild persistent asthma and prescribed maintenance ICS treatment and as needed SABA for ≥12 months prior to enrollment.

• Poor adherence to prescribed maintenance ICS therapy defined as missing ≥4 expected ICS refills in the prior 12 months based on examination of pharmacy records.

• A Medication Adherence Report Scale for Asthma (MARS-A) score <4.5.

• An Asthma Control Test (ACT) score at enrollment ≥12 but <20 indicating partially controlled or moderately uncontrolled asthma.

• iPhone or Android smartphone with an active data plan and willingness to use the sensor device.

Exclusion Criteria:

• Relevant comorbid pulmonary diseases including, but not limited to, chronic obstructive pulmonary disease (COPD), cystic fibrosis, and alpha 1 anti-trypsin deficiency.

• Current or recent use of a biologic medication or investigational treatment for asthma in the 12 months prior to enrollment.

• Current or recent tobacco or illicit substance use (including e-cigarettes) in the 12 months prior to enrollment. Former smokers should not have >15 pack-year history.

• Asthma that is deemed moderate to severe (GINA Step 3-5) wherein symptom-driven ICS/LABA is no longer recommended.

• History of asthma requiring ICU admission in the last 2 years wherein as-needed ICS/LABA is no longer be recommended.

• Use of an inhaler that is not compatible with a inhaler sensor (Proventil, AirDuo).

• Unwillingness or inability to pay potential inhaler cost. Of note, budesonide/formoterol is formulary tier 1-2 for Missouri Medicaid and most commercial insurances.

• Currently or planning to become pregnant.

• Any clinically significant abnormalities on physical exam, laboratory testing, or baseline diagnostic testing that the study team believes will make the study unsafe.