Chronic Obstructive Pulmonary Disease (COPD)NCT07447232
Comparing Ultrasonic and Conventional Spirometry in Chronic Respiratory Disease
A study testing Spirometer in people with Chronic Obstructive Pulmonary Disease (COPD) and Spirometry, run by Fu Jen Catholic University at 1 site in Taiwan.
Trial summary
This study compares a handheld ultrasonic spirometer with a standard hospital spirometer in adults with chronic respiratory diseases. Each participant will complete lung function tests using both devices. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), Spirometry
- What is being tested?
- Spirometer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 Jun 2026to 31 Jul 2026
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 80 years.
- Diagnosed with a chronic respiratory disease (e.g., COPD, asthma, bronchiectasis, or interstitial lung disease).
- Willing to follow the instructions for using the ultrasonic spirometer.
- Clinically stable and able to understand the study purpose and procedures, and who provide informed consent.
Who cannot join
- Individuals who, after explanation, are still unable to properly perform the ultrasonic spirometry procedure.
- Individuals who, after explanation, refuse to participate in the study.
- Patients with unstable vital signs.
- Pregnant or suspected pregnant women.
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, 1 recruiting
- Recruiting
Cardinal Tien Hospital
New Taipei City, 23148
Ke-Yun Chao, PhD, +886-905-301-879, 148540@mail.fju.edu.tw
Ke-Yun Chao, PhD
About this study
Official title: A Comparative Study of Ultrasonic and Conventional Spirometers in Patients With Chronic Respiratory Diseases
This study compares a handheld ultrasonic spirometer with a standard hospital spirometer in adults with chronic respiratory diseases. Each participant will complete lung function tests using both devices. The study aims to determine whether the ultrasonic device provides accurate and reliable measurements for use in clinical or home settings.
Read the detailed description
This study aims to compare a new ultrasonic handheld spirometer with the standard hospital spirometer used in lung function testing. We want to find out whether the ultrasonic device can measure breathing strength and lung capacity as accurately and reliably as the traditional machine.
Adults with chronic respiratory diseases-including COPD, asthma, bronchiectasis, and interstitial lung disease-will participate. Each participant will perform lung function tests using both devices in a randomized order. The results from the two methods will then be compared to see how closely they match.
The goal of this study is to determine whether the ultrasonic spirometer can be used as a convenient alternative tool for lung function monitoring in clinics, community settings, or at home.
- Being tested
- Spirometer
- Keywords
- Chronic Obstructive Pulmonary Disease (COPD), Spirometry, Ultrasonic Flow Sensor, Pulmonary Function Test
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpirometerDiagnostic test
The handheld ultrasonic spirometry device uses acoustic flow analysis to measure FEV1, FVC, and PEF and is evaluated for accuracy compared with the conventional spirometer. Participants may perform this test either before or after the conventional spirometry test, depending on the randomized crossover sequence.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Spirometer | Experimental | Standard hospital spirometry performed according to ATS/ERS procedures to obtain FEV1, FVC, and PEF. In this study, spirometry is performed using the Conventional Spirometer first, followed by the Ultrasonic Spirometer. Receives: Diagnostic Test: Spirometer |
| Ultrasonic Spirometer | Experimental | Standard hospital spirometry performed according to ATS/ERS procedures to obtain FEV1, FVC, and PEF. In this study, spirometry is performed using the Ultrasonic Spirometer first, followed by the Conventional Spirometer. Receives: Diagnostic Test: Spirometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement of FEV1 between Ultrasonic and Conventional Spirometers
Agreement of forced expiratory volume in one second (FEV1) measured by the ultrasonic spirometer compared with the conventional spirometer, assessed using Bland-Altman analysis and correlation coefficients.
Measured: one day
Secondary outcomes (1)
Test-Retest Reliability of Ultrasonic Spirometer (Reproducibility)
Assessment of within-device repeatability of the ultrasonic spirometer across three forced expiratory maneuvers, evaluated by intraclass correlation coefficients (ICC) and coefficient of variation.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start29 Jun 2026
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Jul 2026 (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 Disease (COPD)Studies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447232
- Sponsor's protocol ID
- FJUH114492
- Status last verified
- Feb 2026
- First submitted
- 21 Nov 2025
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Ultrasonic and Conventional Spirometers in Patients With Chronic Respiratory Diseases
- ClinicalTrials.gov ID
- NCT07447232
- Acronym / sponsor ID
- FJUH114492
- Keywords
- Chronic Obstructive Pulmonary Disease (COPD), Spirometry, Ultrasonic Flow Sensor, Pulmonary Function Test
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fu Jen Catholic UniversityUniversity, hospital or other
- Study start
- 29 Jun 2026 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 3 Mar 2026 (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 compares a handheld ultrasonic spirometer with a standard hospital spirometer in adults with chronic respiratory diseases. Each participant will complete lung function tests using both devices. The study aims to determine whether the ultrasonic device provides accurate and reliable measurements for use in clinical or home settings.
Detailed description
This study aims to compare a new ultrasonic handheld spirometer with the standard hospital spirometer used in lung function testing. We want to find out whether the ultrasonic device can measure breathing strength and lung capacity as accurately and reliably as the traditional machine.
Adults with chronic respiratory diseases-including COPD, asthma, bronchiectasis, and interstitial lung disease-will participate. Each participant will perform lung function tests using both devices in a randomized order. The results from the two methods will then be compared to see how closely they match.
The goal of this study is to determine whether the ultrasonic spirometer can be used as a convenient alternative tool for lung function monitoring in clinics, community settings, or at home.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Spirometer | Experimental | Diagnostic Test: SpirometerStandard hospital spirometry performed according to ATS/ERS procedures to obtain FEV1, FVC, and PEF. In this study, spirometry is performed using the Conventional Spirometer first, followed by the Ultrasonic Spirometer. |
| Ultrasonic Spirometer | Experimental | Diagnostic Test: SpirometerStandard hospital spirometry performed according to ATS/ERS procedures to obtain FEV1, FVC, and PEF. In this study, spirometry is performed using the Ultrasonic Spirometer first, followed by the Conventional Spirometer. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 to 80 years.
- Diagnosed with a chronic respiratory disease (e.g., COPD, asthma, bronchiectasis, or interstitial lung disease).
- Willing to follow the instructions for using the ultrasonic spirometer.
- Clinically stable and able to understand the study purpose and procedures, and who provide informed consent.
Key exclusion criteria (4 listed)
- Individuals who, after explanation, are still unable to properly perform the ultrasonic spirometry procedure.
- Individuals who, after explanation, refuse to participate in the study.
- Patients with unstable vital signs.
- Pregnant or suspected pregnant women.
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 |
|---|---|---|
| SpirometerThe handheld ultrasonic spirometry device uses acoustic flow analysis to measure FEV1, FVC, and PEF and is evaluated for accuracy compared with the conventional spirometer. Participants may perform this test either before or after the conventional spirometry test, depending on the randomized crossover sequence. | Diagnostic test | Conventional Spirometer, Ultrasonic Spirometer |
Primary outcome
Agreement of FEV1 between Ultrasonic and Conventional Spirometers
Time frame: one day
Agreement of forced expiratory volume in one second (FEV1) measured by the ultrasonic spirometer compared with the conventional spirometer, assessed using Bland-Altman analysis and correlation coefficients.
1 secondary outcome
Test-Retest Reliability of Ultrasonic Spirometer (Reproducibility)
Time frame: one day
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 2 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Ke-Yun Chao, PhD principal investigator
Fu Jen Catholic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spirometer in people with Chronic Obstructive Pulmonary Disease (COPD) and Spirometry, 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 2 Jul 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?
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 Ke-Yun Chao, PhD (+886905301879, 148540@mail.fju.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement of FEV1 between Ultrasonic and Conventional Spirometers (time frame: one day). 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 2 Jul 2026.