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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-16

Study Completion Date

2025-11-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Asthma Nonadherence, Medication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomization will occur using a 1:1 ratio with random numbers generated using SAS 9.4

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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As needed inhaled corticosteroid and long-acting beta-agonist

Symptom-driven ICS/LABA treatment strategy

Group Type ACTIVE_COMPARATOR

Adherence to symptom driven budesonide/formoterol as compared to adherence to maintenance ICS and symptom-driven SABA

Intervention Type DRUG

In this study, we propose a pragmatic, pilot, open-label trial where we are comparing adherence to different inhaler regimens. Patients who were previously sub-optimally adherent to maintenance ICS inhalers will either continue receiving maintenance ICS inhalers and symptom-driven SABA inhalers or symptom-driven ICS/LABA inhalers only.

Standard therapy: maintenance inhaled corticosteroid and as needed short-acting beta-agonist

Continue maintenance ICS and SABA therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Adherence to symptom driven budesonide/formoterol as compared to adherence to maintenance ICS and symptom-driven SABA

In this study, we propose a pragmatic, pilot, open-label trial where we are comparing adherence to different inhaler regimens. Patients who were previously sub-optimally adherent to maintenance ICS inhalers will either continue receiving maintenance ICS inhalers and symptom-driven SABA inhalers or symptom-driven ICS/LABA inhalers only.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No