NCT05111262

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

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

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 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
• Nonadherence, Medication

Interventions

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

Timeline

• Start date: 2021-12-16
• Primary completion: 2025-09-30
• Completion: 2025-11-30
• First posted: 2021-11-08
• Last updated: 2025-09-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study