New inhaler approach for asthma patients who struggle with daily medication adherence

Symptom-driven Combination Inhaled Corticosteroids and Long-acting Beta Agonist Therapy for Patients With Asthma Who Are Identified as Non-adherent to Daily Maintenance Inhalers

This study is testing a new inhaler method that lets asthma patients use their medication only when they have symptoms to see if it helps them stick to their treatment better.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 12 Years to 75 Years
• Sex: All
• Sponsor: Washington University School of Medicine (other)
• Locations: 1 site (Saint Louis, Missouri)
• Trial ID: NCT05111262 on ClinicalTrials.gov

What this trial studies

This study evaluates a novel inhaler strategy that allows asthma patients to use symptom-driven inhaled corticosteroids (ICS) instead of relying solely on daily maintenance inhalers. It aims to address the high rates of non-adherence to maintenance ICS therapy, which significantly contribute to asthma-related hospitalizations. The study will involve a pragmatic pilot randomized-controlled trial to assess the acceptance and benefits of this approach among patients with mild to moderate persistent asthma. Additionally, it will utilize electronic sensors to monitor inhaler use and conduct interviews to understand the perspectives of patients and providers regarding inhaler non-adherence.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 12-75 with mild to moderate persistent asthma who have demonstrated suboptimal adherence to prescribed maintenance ICS therapy.

Not a fit: Patients with relevant comorbid pulmonary diseases or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve asthma management and reduce hospitalizations for patients who struggle with adherence to daily inhalers.

How similar studies have performed: While there have been interventions aimed at improving inhaler adherence, this specific symptom-driven approach is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

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.

Where this trial is running

Saint Louis, Missouri

• Washington University in St. Louis School of Medicine — Saint Louis, Missouri, United States (RECRUITING)

Study contacts

• Principal investigator: James G Krings, MD MSc — Washington University School of Medicine
• Study coordinator: Abigail Zulich

Conditions: Asthma, Nonadherence, Medication