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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Bronchiectasis; COPD; Interstitial Lung Disease (ILD); Upper Airway Obstruction; Chronic Respiratory Diseases; Asthma (Diagnosis)

• Study Type: Observational
• Enrollment (Estimated): 4000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study 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).

Description

Inclusion Criteria:

• COPD group:

  • 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：
  • Age：≥3
  • Suspected asthma：Patients with chronic respiratory symptoms but no evidence of variable airflow limitation
  • Confirmed asthma：According to the diagnostic criteria in the 2024 Chinese Guidelines for the Prevention and Treatment of Bronchial Asthma and the 2025 GINA Report, diagnosis requires the presence of recurrent symptoms (such as wheezing, shortness of breath, chest tightness, and cough) that resolve spontaneously or with treatment; evidence of variable airflow limitation (e.g., a positive bronchodilator reversibility test, a positive bronchial provocation test, or an average daily diurnal PEF variability of >10% over at least 7 consecutive days); and the exclusion of alternative diagnoses.

Healthy subjects:

• Age ≥ 3 (See Table 1 for details)
• No respiratory symptoms（cough, expectoration, shortness of breath, wheezing, etc）
• No history of serious cardiopulmonary or other systemic diseases, especially no history of respiratory diseases and surgery
• No history of respiratory infection within the past 4 weeks; non-smoker or total lifetime smoking < 100 cigarettes
• No history of occupational exposure to harmful gases or dust, or serious pollution of the work or living environment
• No abnormalities on chest physical examination
• No abnormalities were found on chest imaging (X-ray, CT) records within the past year.
• Body mass index within the normal range (18.5~24.9) Confirmed Bronchiectasis Group：
• Age ≥ 3 years
• Clinical history consistent with bronchiectasis, confirmed by CT scan
• No other concurrent or accompanying respiratory diseases at present Confirmed ILD Group：
• Age ≥ 3 years
• Fibrotic interstitial lung disease: HRCT scan shows fibrotic lung disease, defined as reticular abnormalities and traction bronchiectasis with or without honeycombing, and the disease extent > 10%; or lung tissue biopsy indicates fibrotic interstitial changes
• No other concurrent or accompanying respiratory diseases at present Confirmed Upper Airway Obstruction Group：
• Age ≥ 3 years, gender not restricted
• History of upper airway inflammation, injury, endotracheal intubation or tracheotomy, burns, foreign body aspiration, tracheal tumor, or other conditions that can cause large airway obstruction
• Clinical manifestations are mainly dyspnea and shortness of breath, which are significantly aggravated after activity, and sometimes symptom exacerbation is related to body position
• Pulmonary function test shows significant limitation of inspiratory or expiratory flow in the F-V curve, presenting a characteristic plateau pattern
• At least one of the following evidences: chest CT scan or upper airway three-dimensional reconstruction confirms upper airway stenosis; laryngoscopy or bronchoscopy reveals tracheal/bronchial wall thickening and/or stenosis, intratracheal nodules or neoplasms, tumor infiltration, tracheal mucosal congestion, tracheal cartilage collapse, etc

Exclusion Criteria:

• • 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;
  • Participants deemed unlikely by the researcher to comply with research procedures and restrictions.

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort
Health Group; Age ≥ 3 (See Table 1 for details); No respiratory symptoms（cough, expectoration, shortness of breath, wheezing, etc）; No history of serious cardiopulmonary or other systemic diseases, especially no history of respiratory diseases and surgery; No history of respiratory infection within the past 4 weeks; non-smoker or total lifetime smoking < 100 cigarettes; No history of occupational exposure to harmful gases or dust, or serious pollution of the work or living environment; No abnormalities on chest physical examination; No abnormalities were found on chest imaging (X-ray, CT) records within the past year.; Body mass index within the normal range (18.5~24.9)
COPD group; 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; Age：≥3; Suspected asthma：Patients with chronic respiratory symptoms but no evidence of variable airflow limitation; Confirmed asthma：According to the diagnostic criteria in the 2024 Chinese Guidelines for the Prevention and Treatment of Bronchial Asthma and the 2025 GINA Report, diagnosis requires the presence of recurrent symptoms (such as wheezing, shortness of breath, chest tightness, and cough) that resolve spontaneously or with treatment; evidence of variable airflow limitation (e.g., a positive bronchodilator reversibility test, a positive bronchial provocation test, or an average daily diurnal PEF variability of >10% over at least 7 consecutive days); and the exclusion of alternative diagnoses.
Confirmed Bronchiectasis Group; Age ≥ 3 years; Clinical history consistent with bronchiectasis, confirmed by CT scan; No other concurrent or accompanying respiratory diseases at present
Confirmed ILD Group; Age ≥ 3 years; Fibrotic interstitial lung disease: HRCT scan shows fibrotic lung disease, defined as reticular abnormalities and traction bronchiectasis with or without honeycombing, and the disease extent > 10%; or lung tissue biopsy indicates fibrotic interstitial changes; No other concurrent or accompanying respiratory diseases at present
Confirmed Upper Airway Obstruction Group; Age ≥ 3 years, gender not restricted; History of upper airway inflammation, injury, endotracheal intubation or tracheotomy, burns, foreign body aspiration, tracheal tumor, or other conditions that can cause large airway obstruction; Clinical manifestations are mainly dyspnea and shortness of breath, which are significantly aggravated after activity, and sometimes symptom exacerbation is related to body position; Pulmonary function test shows significant limitation of inspiratory or expiratory flow in the F-V curve, presenting a characteristic plateau pattern; At least one of the following evidences: chest CT scan or upper airway three-dimensional reconstruction confirms upper airway stenosis; laryngoscopy or bronchoscopy reveals tracheal/bronchial wall thickening and/or stenosis, intratracheal nodules or neoplasms, tumor infiltration, tracheal mucosal congestion, tracheal cartilage collapse, etc

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	one day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	one day
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	one day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	one day

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): July 30, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): August 30, 2027

Study Registration Dates

• First Submitted: June 2, 2026
• First Submitted That Met QC Criteria: June 2, 2026
• First Posted (Actual): June 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Respiratory Insufficiency; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; Asthma; Disease; Lung Diseases, Interstitial; Airway Obstruction; Bronchiectasis
• Other Study ID Numbers: D589BL00079

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The informed consent form signed by participants did not include provisions for sharing individual participant data with researchers outside the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No