3D-printed device to help deliver medication for chronic respiratory diseases
Exploring the Benefits of a 3D-Printed Aerosolized Medication Delivery Assist Device in Patients With Chronic Respiratory Diseases
This study is testing a 3D-printed device to see if it can help people with chronic respiratory diseases use their inhalers more easily and stick to their medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 45 Years to 80 Years |
| Sex | All |
| Sponsor | Fu Jen Catholic University Academic / other |
| Locations | 1 site (New Taipei City) |
| Trial ID | NCT06315374 on ClinicalTrials.gov |
What this trial studies
This study investigates the benefits of a 3D-printed assistive device designed to enhance the use of soft-mist inhalers in patients with chronic respiratory diseases. The research focuses on improving medication adherence by addressing challenges related to hand strength and coordination that may hinder proper inhaler use. Conducted over one year at Fu Jen Catholic University Hospital, the study will involve 60 participants who will be randomly assigned to either a control group or an experimental group using the assistive device. Data will be collected at two intervals to assess the effectiveness of the intervention.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 45-80 with chronic respiratory diseases who require soft-mist inhaler medication.
Not a fit: Patients who are not first-time users of soft-mist inhalers or who require assistance from caregivers for inhaler operation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve medication adherence and overall health outcomes for patients with chronic respiratory diseases.
How similar studies have performed: While the use of assistive devices in inhalation therapy is a growing area of interest, this specific approach using 3D-printed devices is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 45-80 years * Patients diagnosed with chronic respiratory diseases requiring the use of SMI medication by a physician * Signed informed consent form Exclusion Criteria: * Not a first-time user of SMI medication * Requires assistance from others (primary caregiver or nurse) for the operation of SMI medication * Refusal to participate in the trial
Where this trial is running
New Taipei City
- Fu Jen Catholic University Hospital, Fu Jen Catholic University — New Taipei City, Taiwan (Recruiting)
Study contacts
- Principal investigator: Ke-Yun Chao, PhD — Fu Jen Catholic University Hospital
- Study coordinator: Ke-Yun Chao
- Email: C00152@mail.fjuh.fju.edu.tw
- Phone: +886-905-301-879
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.