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

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: t
View:

• 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)

Locations
United States
Illinois
University of Chicago
RECRUITING
Chicago
Contact Information
Primary
Leah Traeger
ltraeger@bsd.uchicago.edu
847-508-3011
Backup
Valerie Press
vpress@bsd.uchicago.edu
734-717-1131
Time Frame
Start Date: 2025-10-09
Estimated Completion Date: 2026-02-01
Participants
Target number of participants: 140
Treatments
Experimental: Inhaler Trainer Device
The Inhaler Trainer Device will monitor patients' inspiratory waveform to confirm technique compliance based on objective metrics and provide feedback on how to better perform technique. This intervention utilizes an instrumented training inhaler capable of accurately measuring the real-time inspiratory airflow achieved by the user when they perform their inhale maneuver. If a user's inspiratory flow fails to produce an inspiratory waveform with sufficient airflow parameters, the inhaler device may not optimally aerosolize the medication, and the delivered dosage to the lung will be negatively affected. The device measures the most important flow parameters in the users' real-time inspiration performance and translates them into an estimation of the dose delivered to the lung, based on detailed characterization of the user's inhaler product.
Active_comparator: Brief Interventions (BI)
During inpatient admission, participants randomized to the BI condition will receive the following: First, they will undergo an initial assessment of their respiratory inhaler technique using device-specific checklists. 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. The educator will not demonstrate the appropriate use of each inhaler to the patient, though the educator will be free to answer questions about appropriate use if posed by the study subject.
Sponsors
Leads: Koronis Biomedical Technologies
Collaborators: National Institute on Aging (NIA), University of Chicago

This content was sourced from clinicaltrials.gov