NCT05689983

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 12 Years – 17 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 adolescent 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 in Children
• Nonadherence, Medication

Interventions

Type	Name	Description
DRUG	Maintenance ICS and Symptom Driven SABA	In this intervention, patients will be assigned to a standard therapy with a maintenance inhaled corticosteroid (Flovent) and an as needed short-acting beta-agonist and their adherence to this regimen will be assessed and compared to patients taking a regimen with an as needed inhaled corticosteroid and long-acting beta-agonist.
DRUG	Symptom-driven budesonide/formoterol combination	In this intervention, patients will be assigned to a symptom-driven budesonide/formoterol combination therapy (Symbicort) and their adherence to this regimen will be assessed and compared to patients taking a standard therapy with a maintenance inhaled corticosteroid and as needed short-acting beta-agonist.

Timeline

• Start date: 2022-04-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2023-01-19
• Last updated: 2025-09-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study