NCT06315374

3D-Printed Aerosolized Medication Delivery Assist Device in Patients With Chronic Respiratory Diseases

Exploring the Benefits of a 3D-Printed Aerosolized Medication Delivery Assist Device in Patients With Chronic Respiratory Diseases

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Fu Jen Catholic University · Academic / Other
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the auxiliary benefits of three-dimensional printed activating assistive devices for soft-mist inhaler on patients' utilization habit.

Detailed description

Background： The most common treatment for chronic respiratory diseases is inhalation therapy. However, inhalation therapy requires not only correct operating skills, but also exemplary and sustained adherence from the patient. Soft-mist inhaler does not require hand-mouth coordination or minimum inhalation flow rate, and the aerosol release time is longer, which can effectively deliver more medication to the respiratory tract. If the patient is unable to operate the soft-mist inhaler correctly due to abnormal finger joints or weakened hand muscles, it may affect the effectiveness of inhalation. Study Design： This is a one-year, single-centre, prospective randomized controlled, crossover trial. Methods： This study will be conducted in the Chest Medicine Education Room on the 2nd floor of Fu Jen Catholic University Hospital. A total of 60 participants will be recruited and randomly assigned into two groups: the control group and the experimental group. Data collection will be conducted after one month of intervention, followed by a crossover trial. Data will be collected again after the second month of intervention, and statistical analysis will be performed. Effect： This study expect that three-dimensional printed activating assistive devices for soft-mist inhaler will enhance the satisfaction and convenience of elderly patients with chronic respiratory diseases who use soft-mist inhaler, thereby increasing their medication adherence.

Conditions

• Chronic Pulmonary Disease

Interventions

Type	Name	Description
OTHER	Use soft mist inhaler	Only use soft mist inhaler
DEVICE	Use soft mist inhaler with a 3D assistive device	Use soft mist inhaler with a 3D-printed assist device

Timeline

• Start date: 2024-03-28
• Primary completion: 2025-07-31
• Completion: 2025-07-31
• First posted: 2024-03-18
• Last updated: 2026-02-04

Locations

1 site across 1 country: Taiwan