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

NCT05111262 | Active Not Recruiting Phase 1 FDA Drug

• 3 other identifiers: 202108173KL2TR002346UL1TR002345
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Nonadherence, Medication

Outcome Measures

Primary Outcomes (1)

• 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).

  24 weeks

Secondary Outcomes (11)

• Number of asthma exacerbations

  24 weeks

• Time to asthma exacerbation

  24 weeks

• ICS exposure

  24 weeks

• Adverse and serious adverse events

  24 weeks

• Change in Asthma Control Questionnaire (ACQ)

  24 weeks

Study Arms (2)

As needed inhaled corticosteroid and long-acting beta-agonist

ACTIVE COMPARATOR

Symptom-driven ICS/LABA treatment strategy

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

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

NO INTERVENTION

Continue maintenance ICS and SABA therapy

Interventions

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

As needed inhaled corticosteroid and long-acting beta-agonist

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand and provide informed consent.
• Age 12-75 at the time of study enrollment.
• Provider diagnosed mild or moderate persistent asthma and prescribed maintenance ICS treatment and as needed SABA for at least 6 months prior to enrollment.
• 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.
• 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.
• iPhone or Android smartphone with an active data plan and willingness to use the Adherium device.

You may not qualify if:

• 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.
• Current use of a biologic medication or investigational treatment for asthma.
• History of asthma requiring ICU admission in the last year.
• 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.
• Any clinically significant abnormalities on physical exam, laboratory testing, or baseline diagnostic testing that the study team believes will make the study unsafe.
• Patients who do not complete at least 70% of the twice-daily texts during the two weeks after screening.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institutes of Health (NIH): collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Washington University in St. Louis School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• Krings JG, Wojcik KM, Chen V, Sekhar TC, Harris K, Zulich A, Sumino K, Brownson R, Lenze E, Castro M. Symptom-driven inhaled corticosteroid/long-acting beta-agonist therapy for adult patients with asthma who are non-adherent to daily maintenance inhalers: a study protocol for a pragmatic randomized controlled trial. Trials. 2022 Dec 5;23(1):975. doi: 10.1186/s13063-022-06916-3.

  PMID: 36471430 DERIVED

MeSH Terms

Conditions

Asthma; Medication Adherence

Interventions

Formoterol Fumarate

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Officials

• James G Krings, MD MSc

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

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

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: November 8, 2021
• Study Start: December 16, 2021
• Primary Completion: September 30, 2025
• Study Completion: November 30, 2025
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)