Clinical trial NCT05111262: Symptom-driven ICS/LABA Therapy for Patients With Asthma Non-adherent to Daily Maintenance Inhalers
Official title: Symptom-driven Combination Inhaled Corticosteroids and Long-acting Beta Agonist Therapy for Patients With Asthma Who Are Identified as Non-adherent to Daily Maintenance Inhalers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Asthma
Nonadherence, Medication
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2021-11-08
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization will occur using a 1:1 ratio with random numbers generated using SAS 9.4
Primary purpose: OTHER

Brief 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.

Detailed description: While inhaled corticosteroids (ICS) are considered the essential foundation of most asthma therapy, ICS inhaler non-adherence is a notoriously common problem and a significant cause of asthma-related morbidity. Partially acknowledging the problem of non-adherence, international organizations recently made paradigm-shifting recommendations that all patients with mild or mild-to-moderate persistent asthma be considered for symptom-driven ICS-containing inhalers rather than relying on adherence to traditional maintenance ICS inhalers and symptom-driven beta-agonists. With this novel approach, asthma patients are at least exposed to the important anti-inflammatory effects of ICS-containing inhalers when their inhaler is deployed due to symptoms. The proposed study aims to (Aim 1) undertake a pragmatic pilot randomized-controlled trial to evaluate if an inhaler strategy that utilizes symptom-driven ICS inhalers is particularly accepted and beneficial in maintenance ICS inhaler non-adherent asthma patients, and (Aim 2) use a D\&I science conceptual framework to better understand patients' and providers' views of inhaler non-adherence. This study will use an electronic sensor to monitor inhaler adherence and include semi-structured interviews using the Consolidated Framework for Implementation Research (CFIR).

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.

Primary outcomes:
measure: Adherence to inhaler strategy delineated using an electronic inhaler sensor
timeFrame: 24 weeks
Secondary outcomes:
measure: Number of asthma exacerbations
timeFrame: 24 weeks
measure: Time to asthma exacerbation
timeFrame: 24 weeks
measure: ICS exposure
timeFrame: 24 weeks
measure: Adverse and serious adverse events
timeFrame: 24 weeks
measure: Change in Asthma Control Questionnaire (ACQ)
timeFrame: 24 weeks
measure: Change in asthma control test (ACT)
timeFrame: 24 weeks
measure: Change in Asthma Quality of Life Questionnaire (AQLQ)
timeFrame: 24 weeks
measure: Change in Medication Adherence Reporting Scale for Asthma (MARS-A) questionnaire
timeFrame: 24 weeks
measure: Change in IQVIA Treatment Satisfaction Questionnaire for Medication (TSQM)
timeFrame: 24 weeks
measure: Change in The Knowledge, Attitude, and Self-Efficacy Asthma Questionnaire (KASEAQ)
timeFrame: 24 weeks
measure: Change in Feeling of Satisfaction with Inhaler (FSI-10) questionnaire
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: James G Krings, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: