ICS/LABA for Asthma Nonadherence

Palo Alto (17 mi)

Overseen byJames Krings, MD MSc

Age: < 18

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Washington University School of Medicine

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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

This trial is for people aged 18-75 with mild or moderate persistent asthma who have been non-adherent to their daily maintenance inhalers, missing at least two expected refills in the past six months. Participants must have partially controlled or moderately uncontrolled asthma and be willing to use a smartphone-connected device.

Inclusion Criteria

My asthma is partially controlled, with an ACT score between 12 and 20.

I am between 18 and 75 years old.

Exclusion Criteria

I have completed less than 70% of the required texts after screening.

I am currently using a biologic or experimental treatment for asthma.

I was admitted to the ICU for asthma in the past year.

Treatment Details

The study tests if using budesonide/formoterol only when symptoms occur is as effective as sticking to regular maintenance inhaler therapy combined with symptom-driven SABA. It aims to address the issue of patients not regularly using their prescribed inhalers.

2Treatment groups

Active Control

Placebo Group

Group I: As needed inhaled corticosteroid and long-acting beta-agonistActive Control1 Intervention

Symptom-driven ICS/LABA treatment strategy

Group II: Standard therapy: maintenance inhaled corticosteroid and as needed short-acting beta-agonistPlacebo Group1 Intervention

Continue maintenance ICS and SABA therapy