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

NCT ID: NCT05689983

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2025-12-01

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 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).

Conditions

Asthma in Children; Nonadherence, Medication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

As needed inhaled corticosteroid and long-acting beta-agonist

Symptom-driven ICS/LABA treatment strategy

Group Type: ACTIVE_COMPARATOR

Symptom-driven budesonide/formoterol combination

Intervention Type: DRUG

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.

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

Continue maintenance ICS and SABA therapy

Group Type: PLACEBO_COMPARATOR

Maintenance ICS and Symptom Driven SABA

Intervention Type: DRUG

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.

Interventions

Maintenance ICS and Symptom Driven SABA

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.

Intervention Type: DRUG

Symptom-driven budesonide/formoterol combination

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.

Intervention Type: DRUG

Eligibility Criteria

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 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.

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: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Krings, MD MSc

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University in St. Louis School of Medicine

St Louis, Missouri, United States

Countries

United States

Other Identifiers

KL2TR002346

Identifier Type: NIH

Identifier Source: secondary_id

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UL1TR002345

Identifier Type: NIH

Identifier Source: secondary_id

View Link

202203033

Identifier Type: -

Identifier Source: org_study_id