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NCT07888712Completed

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

Source: ClinicalTrials.gov · Last updated 22 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
466 (actual)
First submitted
17 Sept 2026
Start date
1 Mar 2025
Primary completion date
1 Mar 2025
Lead sponsor
Ruijin Hospital
Diseases
COPD
NCT number
NCT07888712

What you commit to

  • Study type: Observational
  • Participants enrolled: 466
  • From 1 Mar 2025 to the primary completion date, 1 Mar 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • 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.

Age in the registry: 30 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ruijin hospital
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.