COPD (Chronic Obstructive Pulmonary Disease)NCT07888712
A Prospective, Multicenter, Portable Pulmonary Function Comparison Study Aimed at Evaluating the External Clinical Validation of the Chronic Obstructive Pulmonary Disease Auxiliary Diagnostic Software LH-002 (Version: 2.0.0) in Clinical Diagnosis Accuracy
An observational study of COPD (Chronic Obstructive Pulmonary Disease) and Artificial Intelligence, run by Ruijin Hospital at 1 site in China.
Trial summary
Chronic Obstructive Pulmonary Disease (COPD) is widely underdiagnosed in low- and middle-income countries and regions, due to the lack of accessible tools. Conventional spiromery tests for COPD diagnosis are expensive, require trained personnel to operate properly. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease), Artificial Intelligence, Cough
- How many people
- 466 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 30 Jun 2026
- Phase
- Observational
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Definition of suspected COPD or a population at high risk of COPD: individuals aged over 30 years who have established risk factors for COPD (such as a history of smoking or dust exposure) or symptoms consistent with the clinical manifestations of COPD (such as cough, sputum production, or dyspnea).
Who may be able to join
- Age >30 years;
- Presence of established COPD risk factors (such as a history of smoking or dust exposure) or symptoms consistent with the clinical manifestations of COPD (such as cough, sputum production, or dyspnea);
- Voluntary participation in the study and provision of written informed consent. Exclusion Criteria
- A confirmed diagnosis of COPD, asthma, bronchiectasis, or other chronic respiratory diseases;
- Any contraindication to pulmonary function testing;
- Severe cardiac, hepatic, or renal dysfunction, or psychiatric disorders that precluded cooperation with or completion of the study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Chronic Obstructive Pulmonary Disease (COPD) is widely underdiagnosed in low- and middle-income countries and regions, due to the lack of accessible tools. Conventional spiromery tests for COPD diagnosis are expensive, require trained personnel to operate properly. Portable spirometry highly relies on the quality assurance of the tests. Since artificial intelligence (AI)-based cough analysis has demonstrated promising results in COPD diagnosis, this study aimed to evaluate the accuracy of an AI-based cough analysis software (Cough Search) compared to a portable spirometer for the auxiliary diagnosis of COPD.
- Conditions
- COPD (Chronic Obstructive Pulmonary Disease), Artificial Intelligence, Cough, Diagnosis, Spirometry, Screening
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Cough, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Definition of suspected COPD or a population at high risk of COPD | Definition of suspected COPD or a population at high risk of COPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity, specificity, and area under the receiver operating characteristic curve of LH-002 for COPD diagnosis
The diagnostic performance of the LH-002 COPD auxiliary diagnostic software will be evaluated against the clinical reference diagnosis established by independent respiratory physicians according to the GOLD 2024 criteria. The clinical reference diagnosis will incorporate post-bronchodilator spirometry, with an FEV1/FVC ratio of less than 0.70 indicating persistent airflow obstruction, together with relevant clinical information. Sensitivity and specificity will be reported with exact 95% confidence intervals calculated using the Clopper-Pearson method. The area under the receiver operating characteristic curve will be reported with a 95% confidence interval calculated using the DeLong method.
Measured: During the single study visit, after completion of the LH-002 assessment and pre- and post-bronchodilator portable spirometry, up to 1 day
Paired differences in sensitivity and specificity between LH-002 and portable spirometry for COPD diagnosis
The sensitivity and specificity of LH-002 and portable spirometry for COPD diagnosis will be compared using paired data, with the clinical reference diagnosis as the reference standard. Superiority in sensitivity will be evaluated using the difference defined as sensitivity of LH-002 minus sensitivity of portable spirometry. Superiority will be concluded if the lower bound of the 95% confidence interval for this difference is greater than 0. Non-inferiority in specificity will be evaluated using the difference defined as specificity of LH-002 minus specificity of portable spirometry, with a non-inferiority margin of -0.05. Non-inferiority will be concluded if the lower bound of the 95% confidence interval is greater than -0.05. Paired comparisons will be performed using the McNemar test or an equivalent method.
Measured: During the single study visit, after completion of both LH-002 assessment and portable spirometry, up to 1 day
Secondary outcomes (3)
Sensitivity, specificity, and area under the receiver operating characteristic curve of LH-002 for COPD diagnosis in prespecified subgroups
The diagnostic performance of LH-002 will be evaluated in prespecified subgroups defined by age (younger than 40 years, 40 to 64 years, and 65 years or older), sex, smoking history, COPD severity according to GOLD grades 1 to 4, and relevant comorbid respiratory conditions, including asthma, bronchiectasis, acute upper or lower respiratory tract infection, and chronic bronchitis. Sensitivity, specificity, and area under the receiver operating characteristic curve will be reported with 95% confidence intervals for each subgroup.
Measured: During the single study visit, after completion of the diagnostic assessments, up to 1 day
Time required to complete one LH-002 assessment compared with one portable spirometry test
The completion time, measured in minutes, will be recorded for one LH-002 assessment and one portable spirometry test. For LH-002, completion time will be measured from the time the device is ready and cough recording begins until the diagnostic report is generated. For portable spirometry, completion time will be measured from the start of the test procedure until the pulmonary function report is obtained. The paired mean or median difference between the two methods will be reported with a 95% confidence interval. A paired t test will be used for normally distributed data; otherwise, the Wilcoxon signed-rank test will be used.
Measured: During the single study visit, with the completion time recorded for each diagnostic method, up to 1 day
System Usability Scale scores for LH-002 and portable spirometry reported by healthcare professionals
Healthcare professionals operating LH-002 and portable spirometry will complete the System Usability Scale. The System Usability Scale provides a total score ranging from 0 to 100, with higher scores indicating better perceived usability. Scores for each method and the paired difference between methods will be summarized as mean and standard deviation or median and interquartile range, as appropriate, together with 95% confidence intervals. Paired comparisons will use a paired t test for normally distributed data or the Wilcoxon signed-rank test otherwise.
Measured: Immediately after the healthcare professional completes both diagnostic procedures during the single study visit, up to 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start1 Mar 2025
- Primary completion1 Mar 2025
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 466 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07888712
- Sponsor's protocol ID
- 2023-199-02
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 22 Oct 2026
- Results posted
- 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 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Portable Pulmonary Function Comparison Study Aimed at Evaluating the External Clinical Validation of the Chronic Obstructive Pulmonary Disease Auxiliary Diagnostic Software LH-002 (Version: 2.0.0) in Clinical Diagnosis Accuracy
- ClinicalTrials.gov ID
- NCT07888712
- Acronym / sponsor ID
- 2023-199-02
- Conditions
- COPD (Chronic Obstructive Pulmonary Disease), Artificial Intelligence, Cough, Diagnosis, Spirometry, Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 466 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 22 Oct 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.
Chronic Obstructive Pulmonary Disease (COPD) is widely underdiagnosed in low- and middle-income countries and regions, due to the lack of accessible tools. Conventional spiromery tests for COPD diagnosis are expensive, require trained personnel to operate properly. Portable spirometry highly relies on the quality assurance of the tests. Since artificial intelligence (AI)-based cough analysis has demonstrated promising results in COPD diagnosis, this study aimed to evaluate the accuracy of an AI-based cough analysis software (Cough Search) compared to a portable spirometer for the auxiliary diagnosis of COPD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Definition of suspected COPD or a population at high risk of COPD | – | –Definition of suspected COPD or a population at high risk of COPD |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Definition of suspected COPD or a population at high risk of COPD: individuals aged over 30 years who have established risk factors for COPD (such as a history of smoking or dust exposure) or symptoms consistent with the clinical manifestations of COPD (such as cough, sputum production, or dyspnea).
Key inclusion criteria (6 listed)
- Age >30 years;
- Presence of established COPD risk factors (such as a history of smoking or dust exposure) or symptoms consistent with the clinical manifestations of COPD (such as cough, sputum production, or dyspnea);
- Voluntary participation in the study and provision of written informed consent. Exclusion Criteria
- A confirmed diagnosis of COPD, asthma, bronchiectasis, or other chronic respiratory diseases;
- Any contraindication to pulmonary function testing;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity, specificity, and area under the receiver operating characteristic curve of LH-002 for COPD diagnosis
Time frame: During the single study visit, after completion of the LH-002 assessment and pre- and post-bronchodilator portable spirometry, up to 1 day
The diagnostic performance of the LH-002 COPD auxiliary diagnostic software will be evaluated against the clinical reference diagnosis established by independent respiratory physicians according to the GOLD 2024 criteria. The clinical reference diagnosis will incorporate post-bronchodilator spirometry, with an FEV1/FVC ratio of less than 0.70 indicating persistent airflow obstruction, together with relevant clinical information. Sensitivity and specificity will be reported with exact 95% confidence intervals calculated using the Clopper-Pearson method. The area under the receiver operating characteristic curve will be reported with a 95% confidence interval calculated using the DeLong method.
Paired differences in sensitivity and specificity between LH-002 and portable spirometry for COPD diagnosis
Time frame: During the single study visit, after completion of both LH-002 assessment and portable spirometry, up to 1 day
The sensitivity and specificity of LH-002 and portable spirometry for COPD diagnosis will be compared using paired data, with the clinical reference diagnosis as the reference standard. Superiority in sensitivity will be evaluated using the difference defined as sensitivity of LH-002 minus sensitivity of portable spirometry. Superiority will be concluded if the lower bound of the 95% confidence interval for this difference is greater than 0. Non-inferiority in specificity will be evaluated using the difference defined as specificity of LH-002 minus specificity of portable spirometry, with a non-inferiority margin of -0.05. Non-inferiority will be concluded if the lower bound of the 95% confidence interval is greater than -0.05. Paired comparisons will be performed using the McNemar test or an equivalent method.
3 secondary outcomes
Sensitivity, specificity, and area under the receiver operating characteristic curve of LH-002 for COPD diagnosis in prespecified subgroups
Time frame: During the single study visit, after completion of the diagnostic assessments, up to 1 day
Time required to complete one LH-002 assessment compared with one portable spirometry test
Time frame: During the single study visit, with the completion time recorded for each diagnostic method, up to 1 day
System Usability Scale scores for LH-002 and portable spirometry reported by healthcare professionals
Time frame: Immediately after the healthcare professional completes both diagnostic procedures during the single study visit, up to 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD (Chronic Obstructive Pulmonary Disease) and Artificial Intelligence, run by Ruijin Hospital at 1 site in China.
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 6 inclusion and 0 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: finished, as of the sponsor's last update on 22 Oct 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 China. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sensitivity, specificity, and area under the receiver operating characteristic curve of LH-002 for COPD diagnosis (time frame: During the single study visit, after completion of the LH-002 assessment and pre- and post-bronchodilator portable spirometry, up to 1 day). The study lists 2 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 22 Oct 2026.