NCT06315374

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 18, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

March 28, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

1.3 years

First QC Date

March 11, 2024

Last Update Submit

February 2, 2026

Conditions

Chronic Pulmonary Disease

Keywords

Soft mist inhalerdevice errorhand strengthfinger muscle powercoordination

Outcome Measures

Primary Outcomes (1)

  • satisfaction survey

    feedback and satisfaction regarding the initiation of SMI medication with 3D-printed aerosolized medication delivery assist device (maximun 35 and minimum 7), higher means a better outcome

    1 month after the intervention

Study Arms (2)

Simply using soft mist inhaler

ACTIVE COMPARATOR

Routine use of soft mist inhaler only

Other: Use soft mist inhaler

Use soft mist inhaler with a 3D assistive device

EXPERIMENTAL

Use soft mist inhaler with a 3D-printed assist device

Device: Use soft mist inhaler with a 3D assistive device

Interventions

Use soft mist inhalerOTHER

Only use soft mist inhaler

Simply using soft mist inhaler
Use soft mist inhaler with a 3D assistive deviceDEVICE

Use soft mist inhaler with a 3D-printed assist device

Use soft mist inhaler with a 3D assistive device

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 45-80 years
  • Patients diagnosed with chronic respiratory diseases requiring the use of SMI medication by a physician
  • Signed informed consent form

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fu Jen Catholic University Hospital, Fu Jen Catholic University

New Taipei City, 24352, Taiwan

Location

Study Officials

  • Ke-Yun Chao, PhD

    Fu Jen Catholic University Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Group leader of Respiratory Therapists

Study Record Dates

First Submitted

March 11, 2024

First Posted

March 18, 2024

Study Start

March 28, 2024

Primary Completion

July 31, 2025

Study Completion

July 31, 2025

Last Updated

February 4, 2026

Record last verified: 2026-02

Locations

TW(1)