Construction and Validation of an Impulse Oscillometry (IOS)-Based Platform for Screening, Diagnosis, and Management of Chronic Airway Diseases

NCT07910409 · tracked via the Priya Life Science China tracker

Sponsor

Beijing Chao Yang Hospital

Phase

Observational

Started

2026-04-01

Last updated

2026-11-02

Condition(s) studied

Chronic Obstructive Pulmonary Disease (COPD)Asthma (Diagnosis)

Study summary

This is a multicenter, observational study aiming to construct and validate an Impulse Oscillometry (IOS)-based platform for the screening, diagnosis, and management of chronic airway diseases (COPD and asthma). The study consists of two phases. Phase 1 is a cross-sectional study to build and validate diagnostic models for COPD and asthma using IOS parameters, with respiratory specialists' clinical diagnosis as the gold standard. Phase 2 is a 48-week prospective cohort study to develop a prognostic model for predicting acute exacerbation risk based on IOS parameters. Approximately 2,800 participants will be enrolled from hospitals, physical examination centers, and community health centers across China. The results will provide evidence for the clinical application of IOS technology in chronic airway disease management.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Accepted

Inclusion Criteria: * Age 18 to 80 years. * Phase 1: Participants from respiratory and critical care medicine outpatient clinics, physical examination centers, and community health centers; conscious, with basic communication and comprehension ability, able to cooperate with questionnaires and IOS/spirometry examinations; willing to sign written informed consent. * Phase 2: Patients with confirmed stable COPD (meeting GOLD criteria) or asthma (meeting GINA criteria); stable disease defined as no acute exacerbation within the past 4 weeks, without the need for systemic glucocorticoids or increased routine medication; willing to sign written informed consent. Exclusion Criteria: * Phase 1: Respiratory infection within the past 4 weeks; other severe pulmonary diseases affecting lung function (e.g., active tuberculosis, extensive bronchiectasis, pulmonary fibrosis, chest wall deformity, lung cancer); severe dysfunction of heart, brain, liver, or kidney (e.g., NYHA class III-IV, severe arrhythmia, uremia) or uncontrolled malignancy; cognitive impairment or psychiatric disorders; pregnancy or lactation; contraindications to pulmonary function tests. * Phase 2: Comorbid severe respiratory diseases (e.g., bronchiectasis, pulmonary fibrosis, lung cancer, active tuberculosis); severe heart, liver, or kidney dysfunction (e.g., NYHA class III-IV, end-stage liver disease, dialysis-dependent renal disease); conditions affecting pulmonary function test accuracy (e.g., chest wall deformity, pneumothorax, recent thoracic or abdominal surgery); severe cognitive impairment, psychiatric disorders, or communication barriers; planned relocation within 1 year or inability to complete regular follow-up; pregnancy or lactation.

Primary outcome measure(s)

Diagnostic performance of IOS-based models for COPD and asthma — At enrollment (cross-sectional assessment)
Area under the receiver operating characteristic curve (AUC), sensitivity, specificity, positive predictive value, negative predictive value, and optimal diagnostic cutoff values of IOS-based diagnostic models for COPD and asthma, using respiratory specialists' clinical diagnosis as the gold standard.
Acute exacerbation events — Baseline to 48 weeks
Acute exacerbation events, defined as symptom deterioration requiring systemic glucocorticoid use, antibiotic use, emergency department visits, or hospitalization. Frequency, severity, and duration of emergency department visits or hospitalizations will be recorded.

Trial sites (1)

Facility	City	Region	Status
eijing Chao-Yang Hospital, Capital Medical University	Beijing	Beijing Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07910409 on ClinicalTrials.gov ↗ ← All trials in China