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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.

Studie Overzicht

Studietype

Observationeel

Inschrijving (Geschat)

4000

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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).

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
To evaluate the performance of a diagnostic model for COPD based on oscillometry
Tijdsspanne: one day
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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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.
Tijdsspanne: one day
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.
Tijdsspanne: one day
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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Characterize impulse oscillometry (IOS) features in Chronic respiratory diseases
Tijdsspanne: one day
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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

30 juli 2026

Primaire voltooiing (Geschat)

30 juli 2027

Studie voltooiing (Geschat)

30 augustus 2027

Studieregistratiedata

Eerst ingediend

2 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

2 juni 2026

Eerst geplaatst (Werkelijk)

8 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

8 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

2 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

The informed consent form signed by participants did not include provisions for sharing individual participant data with researchers outside the study.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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