A Study to Evaluate the Diagnostic Performance of Portable Oscillometry Across Chronic Respirator… (NCT07631507) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Study to Evaluate the Diagnostic Performance of Portable Oscillometry Across Chronic Respiratory Diseases
4,000 participantsStarted 2026-07-30
Plain-language summary
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.
Who can participate
Age range
3 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
* Ag…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is using a portable oscillometry device to help diagnose COPD and other chronic respiratory conditions — how does oscillometry compare to the standard spirometry test I've already had, and could my doctor explain what extra information it might provide?
2Since this trial is focused on diagnosis rather than treatment, does that mean participating wouldn't change how my current condition is actually managed, and should I still be pursuing standard treatment options alongside it?
3The trial covers several different conditions including COPD, asthma, bronchiectasis, and interstitial lung disease — given my specific diagnosis, does my doctor think my case would be a good fit to discuss with the research team once recruiting begins?
4Because this study is listed as 'not yet recruiting,' how long might it realistically be before it opens, and would waiting to hear more about it delay any important decisions about my current care?
5Since this is listed as a diagnostic performance study with no assigned phase, what does my doctor think about the maturity of oscillometry as a technology — is it something already being used clinically, or is its reliability in conditions like mine still being established??
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate the performance of a diagnostic model for COPD based on oscillometry
Timeframe: one day
Trial details
NCT IDNCT07631507
SponsorThe First Affiliated Hospital of Guangzhou Medical University