COPDNCT07631507
A Study to Evaluate the Diagnostic Performance of Portable Oscillometry Across Chronic Respiratory Diseases
An observational study of COPD and Asthma (Diagnosis), run by The First Affiliated Hospital of Guangzhou Medical University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- COPD, Asthma (Diagnosis), Chronic Respiratory Diseases
- How many people
- 4,000 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2026to 30 Aug 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
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 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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).
Who may be able to join
- 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
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- 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
Who cannot join
- • 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.
About this study
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.
- Conditions
- COPD, Asthma (Diagnosis), Chronic Respiratory Diseases, Bronchiectasis, Interstitial Lung Disease (ILD), Upper Airway Obstruction
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma, Disease, Bronchiectasis, Lung Diseases, Interstitial, Airway Obstruction
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 |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one day
Secondary outcomes (2)
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
Measured: 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
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start30 Jul 2026 (estimated)
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Gao, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07631507
- Sponsor's protocol ID
- D589BL00079
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The informed consent form signed by participants did not include provisions for sharing individual participant data with researchers outside the study.