Inhaler Trainer to Improve Inhaler Technique
Inhaler Trainer Efficacy Study: Interactive Training Tool Providing Technique Feedback for COPD/Asthma Medication Delivery
This trial will test whether using an Inhaler Trainer device helps adults with asthma or COPD use their dry-powder inhalers more effectively.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Koronis Biomedical Technologies Industry-sponsored |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06461403 on ClinicalTrials.gov |
What this trial studies
This randomized, controlled trial will enroll 140 adults with physician-diagnosed asthma or COPD at the University of Chicago and randomize them to either the Inhaler Trainer learning program or a standard brief education intervention. At baseline participants complete assessments and spirometry, receive instruction (with the trainer device or standard teaching), and those in the trainer arm will use the device at home for six weeks while it monitors inspiratory waveform and gives objective feedback. Participants return at six weeks for an in-person evaluation of inhaler technique, lung function, and acute care use, and a post-study semi-structured interview will gather user feedback. The trial is designed to determine feasibility and efficacy of ongoing device-supported inhaler skill training compared with brief standard instruction.
Who should consider this trial
Good fit: Adults aged 18–85 with a physician diagnosis of asthma or COPD who are prescribed one of the specified dry-powder inhalers and who have not previously used an auxiliary inhaler trainer and can provide informed consent in English.
Not a fit: Patients not prescribed the listed DPI inhalers, those with cognitive impairment or who cannot consent or understand English, or those whose physician declines participation are unlikely to be eligible or to benefit from this intervention.
Why it matters
Potential benefit: If successful, the device could help patients use their inhalers correctly, improve lung function, and reduce emergency visits related to asthma or COPD.
How similar studies have performed: Prior efforts using inhaler training and feedback-based devices have shown modest improvements in technique and some clinical outcomes, but this specific Inhaler Trainer device has limited randomized trial data so far.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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): 1. Serevent®Diskus®(GSK), Salmeterol 2. Incruse Ellipta (GSK), Umeclidinium 3. Spiriva Handihaler (BIP),Tiotropium 4. 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 Criteria: * 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 this trial is running
Chicago, Illinois
- University of Chicago — Chicago, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Leah Traeger
- Email: ltraeger@bsd.uchicago.edu
- Phone: 847-508-3011
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.