New inhaler approach for adolescents with asthma who struggle with daily medication

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

This study is testing a new inhaler method for teenagers with asthma who have trouble using their daily inhalers to see if using it only when they have symptoms helps them manage their asthma better.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 12 Years to 17 Years
• Sex: All
• Sponsor: Washington University School of Medicine (other)
• Locations: 1 site (Saint Louis, Missouri)
• Trial ID: NCT05689983 on ClinicalTrials.gov

What this trial studies

This study evaluates a novel inhaler strategy that allows adolescents with asthma, who have difficulty adhering to daily maintenance inhalers, to use symptom-driven inhalers containing inhaled corticosteroids (ICS). The approach aims to provide anti-inflammatory benefits when symptoms arise, potentially improving asthma management. The study will include a pragmatic pilot randomized-controlled trial and utilize electronic sensors to monitor adherence, along with semi-structured interviews to understand patient and provider perspectives on inhaler non-adherence. The goal is to assess the acceptance and effectiveness of this new inhaler strategy in improving asthma control among non-adherent patients.

Who should consider this trial

Good fit: Ideal candidates are adolescents aged 18-75 with mild to moderate persistent asthma who have shown suboptimal adherence to prescribed maintenance ICS therapy.

Not a fit: Patients with relevant comorbid pulmonary diseases such as COPD or cystic fibrosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve asthma management and reduce hospitalizations for adolescents who struggle with medication adherence.

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

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.

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

Conditions: Asthma in Children, Nonadherence, Medication