Inhaler Trainer Efficacy Study
Completed · Not applicable
Conditions studied: Asthma, Copd, Acute Exacerbation of COPD
In brief
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.
Key facts
- Study ID
- NCT06461403
- Run by
- Koronis Biomedical Technologies
- People needed
- 10
- Starts
- 2025-10-09
- Expected to finish
- 2026-04-28
- Last updated by the study team
- 2026-06-08
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
- Does not meet inclusion criteria
Where it is running
- University of Chicago — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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