Chronic Pulmonary DiseaseNCT06315374
3D-Printed Aerosolized Medication Delivery Assist Device in Patients With Chronic Respiratory Diseases
A study testing Use soft mist inhaler and Use soft mist inhaler with a 3D assistive device in people with Chronic Pulmonary Disease, run by Fu Jen Catholic University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Chronic Pulmonary Disease
- What is being tested?
- Use soft mist inhaler and Use soft mist inhaler with a 3D assistive device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Mar 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 45-80 years
- Patients diagnosed with chronic respiratory diseases requiring the use of SMI medication by a physician
- Signed informed consent form
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Fu Jen Catholic University Hospital, Fu Jen Catholic University
New Taipei City, 24352
About this study
Official title: Exploring the Benefits of a 3D-Printed Aerosolized Medication Delivery Assist Device in Patients With Chronic Respiratory Diseases
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.
Read the 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
- Being tested
- Use soft mist inhaler, Use soft mist inhaler with a 3D assistive device
- Keywords
- Soft mist inhaler, device error, hand strength, finger muscle power, coordination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use soft mist inhalerOther
Only use soft mist inhaler
Use soft mist inhaler with a 3D assistive deviceDevice
Use soft mist inhaler with a 3D-printed assist device
| Study group | Role | What they receive |
|---|---|---|
| Simply using soft mist inhaler | Active comparator | Routine use of soft mist inhaler only Receives: 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 Receives: Device: Use soft mist inhaler with a 3D assistive device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start28 Mar 2024
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Why it stopped: Due to persistent challenges in participant recruitment, the study has been terminated and the protocol has been formally withdrawn.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fu Jen Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ke-Yun, Chao, Fu Jen Catholic University
- Investigators
- Ke-Yun Chao, PhD, Principal investigator, Fu Jen Catholic University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315374
- Sponsor's protocol ID
- FJUH112267
- Status last verified
- Feb 2026
- First submitted
- 11 Mar 2024
- Last updated
- 4 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Benefits of a 3D-Printed Aerosolized Medication Delivery Assist Device in Patients With Chronic Respiratory Diseases
- ClinicalTrials.gov ID
- NCT06315374
- Acronym / sponsor ID
- FJUH112267
- Conditions
- Chronic Pulmonary Disease
- Keywords
- Soft mist inhaler, device error, hand strength, finger muscle power, coordination
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to persistent challenges in participant recruitment, the study has been terminated and the protocol has been formally withdrawn.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fu Jen Catholic UniversityUniversity, hospital or other
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simply using soft mist inhaler | Active comparator | Other: Use soft mist inhalerRoutine use of soft mist inhaler only |
| Use soft mist inhaler with a 3D assistive device | Experimental | Device: Use soft mist inhaler with a 3D assistive deviceUse soft mist inhaler with a 3D-printed assist device |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 45-80 years
- Patients diagnosed with chronic respiratory diseases requiring the use of SMI medication by a physician
- Signed informed consent form
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use soft mist inhalerOnly use soft mist inhaler | Other | Simply using soft mist inhaler |
| Use soft mist inhaler with a 3D assistive deviceUse soft mist inhaler with a 3D-printed assist device | Device | Use soft mist inhaler with a 3D assistive device |
Primary outcome
satisfaction survey
Time frame: 1 month after the intervention
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ke-Yun Chao, PhD principal investigator
Fu Jen Catholic University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use soft mist inhaler and Use soft mist inhaler with a 3D assistive device in people with Chronic Pulmonary Disease, run by Fu Jen Catholic University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
satisfaction survey (time frame: 1 month after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.