Chronic Obstructive Pulmonary DiseasepMDIINCT07305649
The Effectiveness of an Innovative Inhalation Training Device in Improving Medication Accuracy, Dyspnea, and Quality of Life in Elderly Patients With Chronic Obstructive Pulmonary Disease
A study testing Innovative Inhaler Training Device (金犀利) and Standard pMDI Inhaler Education in people with Chronic Obstructive Pulmonary Disease, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
This study aims to evaluate the effectiveness of an innovative inhaler training device, "Golden Rhino" (pMDI Practice Tool), in improving inhalation technique accuracy, dyspnea severity, and quality of life among elderly patients with chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Innovative Inhaler Training Device (金犀利) and Standard pMDI Inhaler Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Dec 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 65 years old
- Clinically diagnosed with Chronic Obstructive Pulmonary Disease (COPD) according to GOLD criteria
- Currently using pressurized Metered Dose Inhaler (pMDI) medications
- Ability to communicate and understand instructions in Mandarin or Taiwanese
- Willing to participate and provide informed consent
Who cannot join
- Diagnosis of severe cognitive impairment (e.g., dementia) that may interfere with participation
- Acute COPD exacerbation requiring hospitalization within the past 30 days
- Concurrent enrollment in another interventional clinical trial
- Severe visual or hearing impairment that may limit the ability to follow inhaler training instructions
- Other diagnosed pulmonary diseases (e.g., lung cancer, pulmonary fibrosis) that may affect the assessment of COPD outcomes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Taipei Veterans General Hospital
Taipei, Taipei City, 11217
Lin Hui-Tzu RN, MSN, +886 2 2875 7142, htlin2@vghtpe.gov.tw
About this study
This study aims to evaluate the effectiveness of an innovative inhaler training device, "Golden Rhino" (pMDI Practice Tool), in improving inhalation technique accuracy, dyspnea severity, and quality of life among elderly patients with chronic obstructive pulmonary disease (COPD). The device integrates a weighted valve and musical cues to guide patients in synchronizing their breath with proper pMDI inhalation technique. Participants will be randomly assigned to either standard nursing guidance or nursing guidance plus device-based training. Outcome measures include pMDI usage accuracy, dyspnea severity, and EQ-5D quality of life scores at baseline and follow-up.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) remains a leading cause of morbidity among older adults. Effective pMDI inhalation technique is critical for symptom control, yet improper use is common among elderly patients, especially those with cognitive decline or low health literacy. To address this, we developed an innovative training tool, "Golden Rhino" (patent number M647974, Taiwan), which utilizes a weight-calculated valve to simulate proper inhalation flow (20-60 L/min) and incorporates music cues to assist in breath timing (inhale, hold, exhale).
This randomized controlled trial investigates whether adding this tool to routine nursing education improves pMDI technique accuracy, alleviates dyspnea (via mMRC and CAT), and enhances quality of life (via EQ-5D-5L) in elderly COPD patients. Eligible participants aged 65 years and above will be enrolled from a medical center. Intervention group patients will use the device under nursing instruction for one week. The control group will receive standard verbal instructions only. Assessments occur at baseline, one week, and one month post-intervention.
The device is a non-commercial, research-use-only prototype with no financial gain or commercialization involved. This study has disclosed all relevant intellectual property in the IRB process and participant consent forms.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Innovative Inhaler Training Device (金犀利), Standard pMDI Inhaler Education
- Keywords
- COPD, Inhaler training, pMDI, Elderly patients, Dyspnea, Quality of life, EQ-5D, CAT, mMRC, Inhaler technique
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Innovative Inhaler Training Device (金犀利)Behavioural
This intervention involves the use of an innovative inhaler training device designed to assist elderly COPD patients in mastering the correct pMDI inhalation technique. The device provides visual and auditory feedback during training and is used in conjunction with individualized nursing instruction. The goal is to improve medication administration accuracy, reduce dyspnea, and enhance quality of life.
Standard pMDI Inhaler EducationBehavioural
Participants receive standard pMDI inhaler education only, based on established clinical nursing guidelines. No additional device or interactive training is provided. The education includes written and verbal instructions on proper pMDI use.
| Study group | Role | What they receive |
|---|---|---|
| Innovative Inhaler Training Device | Experimental | Participants receive standard pMDI inhaler education plus training using the innovative inhalation training device (e.g., 金犀利裝置) for three sessions over two weeks. Receives: Behavioral: Innovative Inhaler Training Device (金犀利); Behavioral: Standard pMDI Inhaler Education |
| Standard Nursing Education | Active comparator | Participants receive standard pMDI inhaler education only, based on established clinical nursing guidelines. No additional device or interactive training is provided. The education includes written and verbal instructions on proper pMDI use. Receives: Behavioral: Standard pMDI Inhaler Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dyspnea severity
Dyspnea severity will be measured using the modified Medical Research Council (mMRC) dyspnea scale. The mMRC is a 5-point scale ranging from 0 (no dyspnea) to 4 (dyspnea on minimal exertion). Participants will self-report their score at baseline, post-intervention, and 4-week follow-up. Reduction of at least 1 point is considered clinically significant.
Measured: Pre-intervention, immediately post-intervention, 4 weeks, 12 weeks
Correct use of pMDI inhaler
Correct inhaler technique will be assessed using a 10-item standardized checklist. Each item is scored as correct (1) or incorrect (0). Total scores range from 0 to 10. Participants will be observed by trained nursing staff during inhaler use at three time points: baseline, post-intervention (2 weeks), and follow-up (4 weeks). A score ≥9 is considered correct use.
Measured: Pre-intervention, immediately post-intervention, 4 weeks, 12 weeks
Health-related quality of life (HRQoL)
Health-related quality of life will be assessed using the EQ-5D-5L instrument, including both the index score (calculated using the China value set from Luo et al., 2017, DOI: 10.1007/s10198-017-0870-1
) and the EQ-VAS score. The EQ-5D index score ranges from <0 (worse than death) to 1 (perfect health). The EQ-VAS is a visual analog scale from 0 to 100 representing self-rated health
Measured: Pre-intervention, immediately post-intervention, 4 weeks, 12 weeks
Secondary outcomes (3)
Change in peak expiratory flow (PEF)
Peak expiratory flow will be measured using the MIR Smart One digital spirometer. Participants will perform three trials, and the highest value will be recorded in liters per minute (L/min). PEF reflects airway obstruction and inhalation-exhalation efficacy. Measurements will be taken at baseline, post-intervention (2 weeks), and follow-up (4 weeks).
Measured: Pre-intervention, immediately post-intervention, 4 weeks, 12 weeks
Change in forced expiratory volume in one second (FEV₁)
FEV₁ will also be assessed using the MIR Smart One device. Three measurements will be taken, and the highest value recorded in liters (L). FEV₁ is a standard measure of lung function in COPD and will be compared across time points to assess improvement.
Measured: Pre-intervention, immediately post-intervention, 4 weeks, 12 weeks
Change in COPD Assessment Test (CAT) score
The CAT is an 8-item self-administered questionnaire assessing the impact of COPD on health status. Each item is scored from 0 to 5, with a total score range of 0-40. Higher scores indicate worse health status. A reduction of 2 or more points is considered clinically meaningful.
Measured: Pre-intervention, immediately post-intervention, 4 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start19 Dec 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study adopts a parallel-group, two-arm randomized controlled trial design. Eligible elderly patients with COPD are randomly assigned to the control group (standard nursing guidance) or the experimental group (standard guidance plus an innovative inhaler training tool, "GoldSharp"). Outcomes are compared between groups at three time points.
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07305649
- Sponsor's protocol ID
- 2025-06-003B
- Acronym
- pMDII
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of an Innovative Inhalation Training Device in Improving Medication Accuracy, Dyspnea, and Quality of Life in Elderly Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT07305649
- Acronym / sponsor ID
- pMDII / 2025-06-003B
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Inhaler training, pMDI, Elderly patients, Dyspnea, Quality of life, EQ-5D, CAT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 19 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 26 Dec 2025 (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.
This study aims to evaluate the effectiveness of an innovative inhaler training device, "Golden Rhino" (pMDI Practice Tool), in improving inhalation technique accuracy, dyspnea severity, and quality of life among elderly patients with chronic obstructive pulmonary disease (COPD). The device integrates a weighted valve and musical cues to guide patients in synchronizing their breath with proper pMDI inhalation technique. Participants will be randomly assigned to either standard nursing guidance or nursing guidance plus device-based training. Outcome measures include pMDI usage accuracy, dyspnea severity, and EQ-5D quality of life scores at baseline and follow-up.
Detailed description
Chronic obstructive pulmonary disease (COPD) remains a leading cause of morbidity among older adults. Effective pMDI inhalation technique is critical for symptom control, yet improper use is common among elderly patients, especially those with cognitive decline or low health literacy. To address this, we developed an innovative training tool, "Golden Rhino" (patent number M647974, Taiwan), which utilizes a weight-calculated valve to simulate proper inhalation flow (20-60 L/min) and incorporates music cues to assist in breath timing (inhale, hold, exhale).
This randomized controlled trial investigates whether adding this tool to routine nursing education improves pMDI technique accuracy, alleviates dyspnea (via mMRC and CAT), and enhances quality of life (via EQ-5D-5L) in elderly COPD patients. Eligible participants aged 65 years and above will be enrolled from a medical center. Intervention group patients will use the device under nursing instruction for one week. The control group will receive standard verbal instructions only. Assessments occur at baseline, one week, and one month post-intervention.
The device is a non-commercial, research-use-only prototype with no financial gain or commercialization involved. This study has disclosed all relevant intellectual property in the IRB process and participant consent forms.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study adopts a parallel-group, two-arm randomized controlled trial design. Eligible elderly patients with COPD are randomly assigned to the control group (standard nursing guidance) or the experimental group (standard guidance plus an innovative inhaler training tool, "GoldSharp"). Outcomes are compared between groups at three time points.
| Arm | Type | Receives |
|---|---|---|
| Innovative Inhaler Training Device | Experimental | Behavioral: Innovative Inhaler Training Device (金犀利), Behavioral: Standard pMDI Inhaler EducationParticipants receive standard pMDI inhaler education plus training using the innovative inhalation training device (e.g., 金犀利裝置) for three sessions over two weeks. |
| Standard Nursing Education | Active comparator | Behavioral: Standard pMDI Inhaler EducationParticipants receive standard pMDI inhaler education only, based on established clinical nursing guidelines. No additional device or interactive training is provided. The education includes written and verbal instructions on proper pMDI use. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age ≥ 65 years old
- Clinically diagnosed with Chronic Obstructive Pulmonary Disease (COPD) according to GOLD criteria
- Currently using pressurized Metered Dose Inhaler (pMDI) medications
- Ability to communicate and understand instructions in Mandarin or Taiwanese
- Willing to participate and provide informed consent
Key exclusion criteria (5 listed)
- Diagnosis of severe cognitive impairment (e.g., dementia) that may interfere with participation
- Acute COPD exacerbation requiring hospitalization within the past 30 days
- Concurrent enrollment in another interventional clinical trial
- Severe visual or hearing impairment that may limit the ability to follow inhaler training instructions
- Other diagnosed pulmonary diseases (e.g., lung cancer, pulmonary fibrosis) that may affect the assessment of COPD outcomes
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 |
|---|---|---|
| Innovative Inhaler Training Device (金犀利)This intervention involves the use of an innovative inhaler training device designed to assist elderly COPD patients in mastering the correct pMDI inhalation technique. The device provides visual and auditory feedback during training and is used in conjunction with individualized nursing instruction. The goal is to improve medication administration accuracy, reduce dyspnea, and enhance quality of life. | Behavioural | Innovative Inhaler Training Device |
| Standard pMDI Inhaler EducationParticipants receive standard pMDI inhaler education only, based on established clinical nursing guidelines. No additional device or interactive training is provided. The education includes written and verbal instructions on proper pMDI use. | Behavioural | Innovative Inhaler Training Device, Standard Nursing Education |
Primary outcome
Change in dyspnea severity
Time frame: Pre-intervention, immediately post-intervention, 4 weeks, 12 weeks
Dyspnea severity will be measured using the modified Medical Research Council (mMRC) dyspnea scale. The mMRC is a 5-point scale ranging from 0 (no dyspnea) to 4 (dyspnea on minimal exertion). Participants will self-report their score at baseline, post-intervention, and 4-week follow-up. Reduction of at least 1 point is considered clinically significant.
Correct use of pMDI inhaler
Time frame: Pre-intervention, immediately post-intervention, 4 weeks, 12 weeks
Correct inhaler technique will be assessed using a 10-item standardized checklist. Each item is scored as correct (1) or incorrect (0). Total scores range from 0 to 10. Participants will be observed by trained nursing staff during inhaler use at three time points: baseline, post-intervention (2 weeks), and follow-up (4 weeks). A score ≥9 is considered correct use.
Health-related quality of life (HRQoL)
Time frame: Pre-intervention, immediately post-intervention, 4 weeks, 12 weeks
Health-related quality of life will be assessed using the EQ-5D-5L instrument, including both the index score (calculated using the China value set from Luo et al., 2017, DOI: 10.1007/s10198-017-0870-1 ) and the EQ-VAS score. The EQ-5D index score ranges from <0 (worse than death) to 1 (perfect health). The EQ-VAS is a visual analog scale from 0 to 100 representing self-rated health
3 secondary outcomes
Change in peak expiratory flow (PEF)
Time frame: Pre-intervention, immediately post-intervention, 4 weeks, 12 weeks
Change in forced expiratory volume in one second (FEV₁)
Time frame: Pre-intervention, immediately post-intervention, 4 weeks, 12 weeks
Change in COPD Assessment Test (CAT) score
Time frame: Pre-intervention, immediately post-intervention, 4 weeks, 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Innovative Inhaler Training Device (金犀利) and Standard pMDI Inhaler Education in people with Chronic Obstructive Pulmonary Disease, run by Taipei Veterans General Hospital, Taiwan 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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 26 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lin Hui-Tzu RN, MSN (+886 2 2875 7142, htlin2@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in dyspnea severity (time frame: Pre-intervention, immediately post-intervention, 4 weeks, 12 weeks). The study lists 3 primary outcomes in all. 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 26 Dec 2025.