A Study to Evaluate the Diagnostic Performance of Portable Oscillometry Across Chronic Respiratory Diseases

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3+
SponsorThe First Affiliated Hospital of Guangzhou Medical University

About this trial

This is a prospective, multicenter, observational cohort study enrolling approximately 4,000 subjects across about 50 centers, including patients with COPD (confirmed and suspected), asthma (confirmed and suspected), bronchiectasis, interstitial lung disease (ILD), upper airway obstruction (UAO), and healthy controls. Participants will undergo standardized clinical assessments, cough search, FENO, ETCO2, impulse oscillometry, spirometry, and/or bronchodilator test, and/or bronchoprovocation test, and/or diffusion capacity test at a single baseline visit, with no investigational intervention or treatment assignment. The primary objective is to evaluate the diagnostic performance of portable impulse oscillometry in Chronic respiratory diseases and to develop an artificial intelligence diagnostic model for COPD based on oscillometry. The study duration per subject is limited to the screening/baseline visit, with no follow-up visits planned.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age:≥40

Suspected COPD:COPD-SQ≥16,and no evidence of airflow limitation after bronchodilators

Confirmed COPD:According to the diagnostic criteria in the 2021 Revised Edition of the Chinese Guidelines for the Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease and the 2026 GOLD Report, a diagnosis requires the presence of symptoms (such as dyspnea, chronic cough, or sputum production), a history of exposure to risk factors (e.g., smoking, biomass fuels, occupational exposures, or air pollution), evidence of persistent airflow limitation (post-bronchodilator FEV1/FVC < 0.70), and the exclusion of alternative diagnoses.

Exclude acute exacerbation within the last month Asthma group:

Disqualifiers

• Contraindications for oscillometry testing and spirometry testing: Oscillometry testing: Severe and intolerable dyspnea, acute exacerbation of respiratory infection, uncontrolled epilepsy, oral or facial diseases or deformities preventing proper latching, tympanic membrane perforation, need for continuous oxygen therapy, indwelling gastric tube, tracheotomy with inability to close the tube, currently undergoing artificial ventilation and unable to temporarily stop the procedure; Spirometry testing: Recent severe cardiovascular disease, epileptic seizures, uncontrolled hypertension, aortic aneurysm, severe hyperthyroidism, heart rate >120 bpm, tympanic membrane perforation, other respiratory infectious diseases, etc.;

Other respiratory diseases that affect lung function results: such as lung cancer, pneumonia, active pulmonary tuberculosis, pulmonary embolism, etc.; Recent surgical history that affects lung function results, including open-chest surgery, pleural effusion surgery, etc.;

Poor cooperation during basic lung function tests, failing to meet quality control requirements;

Breastfeeding women;

Trial population

A total of 4,000 participants will be enrolled, comprising 1,000 healthy individuals(≥3 years), 1,400 patients with suspected or confirmed chronic obstructive pulmonary disease (COPD) (ratio 400:1,000, ≥40 years), 1,000 patients with suspected or confirmed asthma (ratio 500:500, ≥3 years), 300 patients with bronchiectasis(≥3 years), 250 patients with interstitial lung disease (ILD)(≥3 years), and 50 patients with upper airway obstruction(≥3 years).

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

4,000 Participants
are grouped into 6 trial groups

6

Trial groups

See each trial group below.

Group A: Health Group
Group B: COPD group
Group C: Asthma group
Group D: Confirmed Bronchiectasis Group
Group E: Confirmed ILD Group
Group F: Confirmed Upper Airway Obstruction Group

Trial outcomes

Primary outcomes

1

To evaluate the performance of a diagnostic model for COPD based on oscillometry

Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) with others(such sensitivity, specificity, Youden's index, accuracy, positive predictive value, and negative predictive value) for individual or combination of any parameters of oscillometry for COPD

Time frame
one day

Secondary outcomes

1

To evaluate the performance of a diagnostic model for COPD based on oscillometry with questionaires and/or cough search and/or Feno and/or ETCO2 etc.

Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) with others(such sensitivity, specificity, Youden's index, accuracy, positive predictive value, and negative predictive value) for individual or combination of any parameters of oscillometry with questionaires and/or cough search and/or FeNO and/or ETCO2 etc.for COPD

Time frame
one day
2

To evaluate the performance of a diagnostic model for asthma based on with/without questionaires and/or cough search and/or Feno etc.

Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) with others(such sensitivity, specificity, Youden's index, accuracy, positive predictive value, and negative predictive value) for individual or combination of any parameters of oscillometry with/without questionaires and/or cough search and/or Feno etc. for asthma

Time frame
one day

Other outcomes

1

Characterize impulse oscillometry (IOS) features in Chronic respiratory diseases

Measures of central tendency (mean or median) and dispersion (standard deviation or interquartile range) of key IOS parameters (e.g., R5, R20, R5-R20, X5, Fres, AX) in patients with COPD, asthma, ILD,bronchiectasis and upper airway obstruction

Time frame
one day

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: