Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

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

2 de junho de 2026 atualizado por: Yi Gao, The First Affiliated Hospital of Guangzhou Medical University
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.

Visão geral do estudo

Tipo de estudo

Observacional

Inscrição (Estimado)

4000

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Método de amostragem

Amostra Não Probabilística

População do estudo

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).

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
To evaluate the performance of a diagnostic model for COPD based on oscillometry
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
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.
Prazo: 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.
Prazo: 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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Characterize impulse oscillometry (IOS) features in Chronic respiratory diseases
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

30 de julho de 2026

Conclusão Primária (Estimado)

30 de julho de 2027

Conclusão do estudo (Estimado)

30 de agosto de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

2 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

2 de junho de 2026

Primeira postagem (Real)

8 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

8 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

2 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

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

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever