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.
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 adolescent 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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
40
In this intervention, patients will be assigned to a standard therapy with a maintenance inhaled corticosteroid (Flovent) and an as needed short-acting beta-agonist and their adherence to this regimen will be assessed and compared to patients taking a regimen with an as needed inhaled corticosteroid and long-acting beta-agonist.
In this intervention, patients will be assigned to a symptom-driven budesonide/formoterol combination therapy (Symbicort) and their adherence to this regimen will be assessed and compared to patients taking a standard therapy with a maintenance inhaled corticosteroid and as needed short-acting beta-agonist.
Washington University in St. Louis School of Medicine
St Louis, Missouri, United States
Adherence to inhaler strategy delineated using an electronic inhaler sensor
The primary outcome will be adherence with an inhaler management strategy delineated using the Adherium inhaler sensor and smartphone application as compared between groups. Adherence to the treatment strategy for the maintenance ICS inhaler group will be calculated as the proportion of maintenance ICS actuations per prescription recommendation. Adherence for the symptom-based ICS treatment strategy will be calculated as the proportion of ICS/LABA actuations per recommendation based on self-report of symptoms (definition: ICS/LABA inhaler actuation during a day or night period divided by a period wherein a patient identified symptoms as \>1 on REDCap-delivered smartphone questionnaire).
Time frame: 24 weeks
Number of asthma exacerbations
Frequency of study-defined asthma exacerbations between groups (adjusted for time on treatment). Asthma exacerbations will be defined as an urgent medical visit for asthma symptoms, prescription of oral corticosteroids for asthma symptoms, or high use of a rescue inhaler (\>16 actuations of SABA or \>8 actuations of ICS/LABA within 24 hours on two consecutive days as assessed via the Adherium device).
Time frame: 24 weeks
Time to asthma exacerbation
Time to first exacerbation between groups. Asthma exacerbations will be defined as an urgent medical visit for asthma symptoms, prescription of oral corticosteroids for asthma symptoms, or high use of a rescue inhaler (\>16 actuations of SABA or \>8 actuations of ICS/LABA within 24 hours on two consecutive days as assessed via the Adherium device)
Time frame: 24 weeks
ICS exposure
Converted cumulative dose of ICS between groups.
Time frame: 24 weeks
Adverse and serious adverse events
Occurrence of any severe and non-severe adverse events between groups.
Time frame: 24 weeks
Change in Asthma Control Questionnaire (ACQ)
Change in Asthma Control Questionnaire (ACQ) from baseline to the final study visit. This is measured using the Asthma Control Questionnaire (ACQ) which is scaled from a minimum of 0 to a maximum of 6 for each question with higher scores indicating greater asthma control.
Time frame: 24 weeks
Change in asthma control test (ACT)
Change in Asthma Control Test (ACT) from baseline to the final study visit. This is measured using the Asthma Control Test (ACT) is scaled on a 5 point Likert scale from a minimum of 1 to a maximum of 5 for each question with higher scores indicating greater asthma control.
Time frame: 24 weeks
Change in Asthma Quality of Life Questionnaire (AQLQ)
Change in Asthma Quality of Life Questionnaire (AQLQ) from baseline to the final study visit. This is measured using the Asthma Quality of Life Questionnaire (AQLQ) which is scaled on a 7 point Likert scale from a minimum of 1 to a maximum of 7 for each question with higher scores indicating no impairment in activities due to asthma.
Time frame: 24 weeks
Change in Medication Adherence Reporting Scale for Asthma (MARS-A) questionnaire
Change in Medication Adherence Reporting Scale for Asthma (MARS-A) questionnaire from baseline to the final study visit. This is measured using the Medication Adherence Reporting Scale for Asthma (MARS-A) questionnaire which is scaled on a 5 point Likert scale from a minimum of 1 to a maximum of 5 for each question with higher scores indicating better adherence to medication.
Time frame: 24 weeks
Change in IQVIA Treatment Satisfaction Questionnaire for Medication (TSQM)
Change in IQVIA Treatment Satisfaction Questionnaire for Medication (TSQM) from baseline to the final study visit. This is measured using the IQVIA Treatment Satisfaction Questionnaire for Medication Version II (TSQM-2) which has 11 questions, 10 of which are scaled on a Likert scale from a minimum of 1 (Extremely Dissatisfied) to a maximum of 7 (Extremely Satisfied) with the exception of one question that asks about the experience of side effects in patients with answer choices of yes or no with higher scores indicating greater patient satisfaction with their medications.
Time frame: 24 weeks
Change in The Knowledge, Attitude, and Self-Efficacy Asthma Questionnaire (KASEAQ)
Change in The Knowledge, Attitude, and Self-Efficacy Asthma Questionnaire (KASEAQ) from baseline to the final study visit. This is measured using the Knowledge, Attitude, and Self-Efficacy Asthma Questionnaire (KASEAQ) which contains a series of statements in the domains of knowledge, attitude, and self-efficacy with answer choices of True, Mostly True, Sometimes True and Sometimes False, Mostly False, and False. Higher scores indicated greater knowledge of asthma and asthma management, greater optimism and willingness in self-management of asthma, and greater confidence in the ability to manage and control asthma.
Time frame: 24 weeks
Change in Feeling of Satisfaction with Inhaler (FSI-10) questionnaire
Change in Feeling of Satisfaction with Inhaler (FSI-10) questionnaire from baseline to the final study visit. This is measured using the Feeling of Satisfaction with Inhaler questionnaire (FSI-10) which contains 10 questions that are scaled on a 5 point Likert scale with answer options ranging from 1 (hardly at all) to 5 (very) with higher scores indicating greater satisfaction with the inhaler.
Time frame: 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.