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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.

調査の概要

研究の種類

観察的

入学 (推定)

4000

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

サンプリング方法

非確率サンプル

調査対象母集団

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).

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
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

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
To evaluate the performance of a diagnostic model for COPD based on oscillometry
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
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.
時間枠: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.
時間枠: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

その他の成果指標

結果測定
メジャーの説明
時間枠
Characterize impulse oscillometry (IOS) features in Chronic respiratory diseases
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年7月30日

一次修了 (推定)

2027年7月30日

研究の完了 (推定)

2027年8月30日

試験登録日

最初に提出

2026年6月2日

QC基準を満たした最初の提出物

2026年6月2日

最初の投稿 (実際)

2026年6月8日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月8日

QC基準を満たした最後の更新が送信されました

2026年6月2日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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