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Handheld breath test could spot lung disease early

NCT ID NCT07631507

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This trial is taking on new participants right now.
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Cancelled before anyone took part.

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Not a trial. The treatment could once be requested outside a study, but no longer can.
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When the status isn't known

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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study evaluates a portable device that measures lung function using oscillometry—a technique that sends gentle sound waves into the lungs—to diagnose chronic respiratory diseases like COPD, asthma, and bronchiectasis. Researchers will enroll about 4,000 adults across 50 centers, including people with known or suspected lung conditions and healthy volunteers. Participants undergo a single visit with breathing tests, and the goal is to see how well the device detects disease compared to standard methods, potentially leading to an AI-based diagnostic tool.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a simple, portable test for diagnosing COPD and other lung diseases without complex equipment.
What could go wrong
This is an observational study, not a treatment trial. The device may not prove accurate enough for widespread use, and results may not apply to all populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 4,000 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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).

Ages

3 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

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