Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
Healthy Volunteers
NCT06461403

Inhaler Trainer Efficacy Study

Led by Koronis Biomedical Technologies · Updated on 2025-10-14

140

Participants Needed

1

Research Sites

16 weeks

Total Duration

On this page

Sponsors

K

Koronis Biomedical Technologies

Lead Sponsor

U

University of Chicago

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Inhaler Trainer Efficacy Study

Who Can Participate

Age: 18Years - 85Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 85 years
  • Physician diagnosis of COPD or asthma
  • Prescribed one of these inhalers: Serevent Diskus (Salmeterol), Incruse Ellipta (Umeclidinium), Spiriva Handihaler (Tiotropium), or Tudorza Pressair (Aclidinium)
  • No prior use of an inhaler trainer device for inhaler training
Not Eligible

You will not qualify if you...

  • Physician declines to provide assent
  • Unable to provide consent due to cognitive impairment or inability to understand English
  • Does not meet inclusion criteria

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Chicago

Chicago, Illinois, United States, 60637

Actively Recruiting

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Research Team

L

Leah Traeger

CONTACT

V

Valerie Press

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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