Inhaler Trainer Efficacy Study

NARecruitingINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

October 9, 2025

Primary Completion Date

February 1, 2026

Study Completion Date

February 1, 2026

Conditions
AsthmaCopdAcute Exacerbation of COPD
Interventions
DEVICE

Inhaler 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.

OTHER

Initial Inhaler Use Assessment

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

OTHER

Inhaler 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.

Trial Locations (1)

60637

RECRUITING

University of Chicago, Chicago

All Listed Sponsors
collaborator

University of Chicago

OTHER

collaborator

National Institute on Aging (NIA)

NIH

lead

Koronis Biomedical Technologies

INDUSTRY