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

Last updated: July 22, 2024
Sponsor: Washington University School of Medicine
Overall Status: Active - Recruiting

Phase

1/2

Condition

Asthma

Treatment

Symptom-driven budesonide/formoterol combination

Maintenance ICS and Symptom Driven SABA

Clinical Study ID

NCT05689983
202203033
UL1TR002345
KL2TR002346
  • Ages 12-17
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Able to understand and provide informed consent.

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

  3. Provider diagnosed mild or moderate persistent asthma and prescribed maintenance ICStreatment and as needed SABA for at least 6 months prior to enrollment.

  4. Suboptimal adherence to prescribed maintenance ICS therapy defined as missing atleast expected 2 ICS refills in the prior 6 months based on examination of pharmacyrecords 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 butless than or equal to 20 indicating partially controlled or moderately uncontrolledasthma.

  6. iPhone or Android smartphone with an active data plan and willingness to use theAdherium device.

Exclusion

Exclusion Criteria:

  1. Relevant comorbid pulmonary diseases including, but not limited to a diagnosis ofchronic obstructive pulmonary disease (COPD), cystic fibrosis, or alpha 1anti-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 Adheriumsensor (fluticasone propionate or budesonide/formoterol). Of note, fluticasone andbudesonide/formoterol are formulary tier 1-2 for Missouri Medicaid and mostcommercial insurances and are believed to be equally or less expensive asalternative inhalers for most patients.

  5. Any clinically significant abnormalities on physical exam, laboratory testing, orbaseline 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 twoweeks after screening.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Symptom-driven budesonide/formoterol combination
Phase: 1/2
Study Start date:
April 01, 2022
Estimated Completion Date:
December 01, 2024

Study 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 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).

Connect with a study center

  • Washington University in St. Louis School of Medicine

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

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