IOS-based platform to screen, diagnose, and manage COPD and asthma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter observational study aims to develop and validate an IOS-based platform for screening, diagnosing, and managing chronic airway diseases. Phase 1 uses IOS measurements to build diagnostic models for COPD and asthma, with clinical diagnoses as the reference standard. Phase 2 follows participants for 48 weeks to create a prognostic model predicting acute exacerbations using IOS parameters. Approximately 2,800 adults across hospital, physical exam, and community centers in China will be enrolled. The study seeks to demonstrate the clinical utility of IOS as a noninvasive, patient-friendly tool that complements spirometry in routine care.

Why it matters

Who can join: the full rules

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.

Where it's running

• eijing Chao-Yang Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Kewu Huang, MD
• Email: kewuhuang@126.com
• Phone: +86-13601234681

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.