RecruitingNot ApplicableNCT06461403

Inhaler Trainer Efficacy Study

Inhaler Trainer Efficacy Study: Interactive Training Tool Providing Technique Feedback for COPD/Asthma Medication Delivery

Sponsor

Koronis Biomedical Technologies

Enrollment

140 participants

Start Date

Oct 9, 2025

Study Type

INTERVENTIONAL

Conditions

Asthma COPD Acute Exacerbation of COPD

Summary

This will be a randomized, controlled, clinical trial. The investigators aim to determine the feasibility of and efficacy of the Inhaler Trainer Device for ongoing inhaler skill training. The research team will enroll 140 patients from the inpatient or outpatient setting from the University of Chicago Medicine over the course of up to 12 months. Participants will complete assessments, a lung function test via spirometry, and inhaler education via either the Inhaler Trainer Device learning program or Brief Intervention. All participants will return at 6 weeks (window of +/- one week) post-initial inhaler education for an in-person evaluation of their inhaler skills, lung function, and acute care utilization. Finally, a post-study semi-structured interview will be conducted to gather feedback on the device after the 6-week visit has been completed.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria8

Age 18-85
Physician diagnosis of COPD or asthma
Has been prescribed or is being prescribed one of the inhalers listed below (DPI inhaler product, Active pharmaceutical ingredient):
Serevent®Diskus®(GSK), Salmeterol
Incruse Ellipta (GSK), Umeclidinium
Spiriva Handihaler (BIP),Tiotropium
Tudorza Pressair (AstraZeneca), Aclidinium
Inexperienced with inhaler trainer device (defined by never having had inhaler training using an auxiliary tool besides an actual inhaler and spacer)

Exclusion Criteria2

Physician declines to provide assent
Patient unable to provide consent (e.g., history of cognitive impairment, unable to understand English) or declines to provide consent

Interventions

DEVICEInhaler Trainer System

The system consists of an instrumented training inhaler capable of accurately measuring the real-time inspiratory airflow achieved by the user when they perform their inhale maneuver. The inhaler trainer system consists of a detachable/disposable mouthpiece and a reusable electronics module. The electronics module measures flow/pressure achieved by the patient and wirelessly transmits this data to a PC. The PC software analyzes the real-time inhalation flow data to enable the monitoring of the following quantities: Flow Rate, Duration, and Maximum Pressure Slope. These quantities will be used in the computation of the assessment metric, providing the user with real-time feedback about their inhalation technique. In addition, the software includes features to support the human study and provides fully functional inhaler education features for the expert test evaluators.

OTHERInitial Inhaler Use Assessment

Patients will undergo an initial assessment of their respiratory inhaler technique for their respiratory inhaler devices using device-specific checklists

OTHERInhaler Use Instruction

Participants will then be given step-by-step verbal instructions and a copy of written instructions by the trained educator describing appropriate inhaler technique for their respiratory inhalers.