3D-Printed Aerosolized Medication Delivery Assist Device... | NCT06315374

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

NCT06315374

Sponsor

Fu Jen Catholic University

Status

Withdrawn

Last Update Posted

Feb 4, 2026Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Chronic Pulmonary Disease

Interventions

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

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to persistent challenges in participant recruitment, the study has been terminated and the protocol has been formally withdrawn.

Expanded Access Info

Start Date

Mar 28, 2024Actual

Primary Completion Date

Jul 31, 2025Actual

Completion Date

Jul 31, 2025Actual

First Submitted Date

Mar 11, 2024

First Submission Date that Met QC Criteria

Mar 11, 2024

First Posted Date

Mar 18, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2026

Last Update Posted Date

Feb 4, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ke-Yun, Chao, Group leader of Respiratory Therapists, Fu Jen Catholic UniversityPrincipal Investigator

Lead Sponsor

Fu Jen Catholic UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Use soft mist inhaler	Other	Only use soft mist inhaler	Simply using soft mist inhaler

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ke-Yun Chao, PhD	Fu Jen Catholic University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fu Jen Catholic University Hospital, Fu Jen Catholic University		New Taipei City		24352	Taiwan