- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07631507
A Study to Evaluate the Diagnostic Performance of Portable Oscillometry Across Chronic Respiratory Diseases
Aperçu de l'étude
Statut
Type d'étude
Inscription (Estimé)
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
|---|
|
Health Group
|
|
COPD group
|
|
Asthma group
|
|
Confirmed Bronchiectasis Group
|
|
Confirmed ILD Group
|
|
Confirmed Upper Airway Obstruction Group
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
To evaluate the performance of a diagnostic model for COPD based on oscillometry
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
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.
Délai: 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.
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Characterize impulse oscillometry (IOS) features in Chronic respiratory diseases
Délai: 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
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Maladie chronique
- Attributs de la maladie
- Maladies du système immunitaire
- Maladies des voies respiratoires
- Maladies pulmonaires
- Troubles respiratoires
- Maladies bronchiques
- Maladies pulmonaires obstructives
- Hypersensibilité respiratoire
- Hypersensibilité immédiate
- Hypersensibilité
- Insuffisance respiratoire
- Conditions pathologiques, signes et symptômes
- Maladie pulmonaire obstructive chronique
- Asthme
- Maladie
- Maladies pulmonaires interstitielles
- Obstruction des voies respiratoires
- Bronchiectasie
Autres numéros d'identification d'étude
- D589BL00079
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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