Trial · 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
NCT07888712, Completed, Ruijin Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT07888712. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07888712
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- 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
- NCT number
- NCT07888712
- Status
- Completed
- Enrollment
- 466 participants, actual
- Lead sponsor
- Ruijin Hospital
- Conditions
- COPD (Chronic Obstructive Pulmonary Disease), Artificial Intelligence, Cough, Diagnosis, Spirometry, Screening
- First posted
- 2026-10-22
- Last updated
- 2026-10-22
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Sensitivity, specificity, and area under the receiver operating characteristic curve of LH-002 for COPD diagnosis | 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. |
| Primary | Paired differences in sensitivity and specificity between LH-002 and portable spirometry for COPD diagnosis | 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. |
| Secondary | Sensitivity, specificity, and area under the receiver operating characteristic curve of LH-002 for COPD diagnosis in prespecified subgroups | During the single study visit, after completion of the diagnostic assessments, up to 1 day | 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. |
| Secondary | Time required to complete one LH-002 assessment compared with one portable spirometry test | During the single study visit, with the completion time recorded for each diagnostic method, up to 1 day | 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. |
| Secondary | System Usability Scale scores for LH-002 and portable spirometry reported by healthcare professionals | Immediately after the healthcare professional completes both diagnostic procedures during the single study visit, up to 1 day | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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GET https://conductscience.org/api/trials/v1/NCT07888712
GET https://conductscience.org/api/trials/v1/NCT07888712/registered