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ACTIVE NOT RECRUITING
NCT05689983
PHASE1/PHASE2

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

Sponsor: Washington University School of Medicine

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

12 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2022-04-01

Completion Date

2025-12-01

Last Updated

2025-09-17

Healthy Volunteers

No

Interventions

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.

Locations (1)

Washington University in St. Louis School of Medicine

St Louis, Missouri, United States