New portable device could speed up asthma diagnosis
NCT ID NCT07516184
First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 4 times
Summary
This study aims to see if a portable device that measures lung function can accurately diagnose asthma in people with symptoms like wheezing or coughing. Researchers will compare this new test to the standard breathing tests currently used. The study plans to enroll 500 adults across 25 sites in China.
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.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide 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: Participants must meet all the following criteria and sign an informed consent form (ICF) to be eligible for the study. 1. Patient must be aged 18-75 years old at the time of enrollment. 2. Presented with asthmatic symptoms such as wheezing, shortness of breath, chest tightness and cough ≥2 months prior to enrollment (Day 0), with/without an established asthma diagnosis. Exclusion Criteria: Patients are excluded from the study if any of the following criteria apply: Medical Conditions 1. Respiratory infections within 3 months prior to enrollment (Day 0), including but not limited to: acute bacterial/viral pneumonia, acute bronchitis, Influenza, COVID-19 or acute exacerbation of chronic bronchitis. 2. Current smoker; or cessation from smoking less than 6 months; or cessation smoking for more than 6 months but smoked more than 10 packs/year. 3. History of other chronic respiratory diseases other than asthma, including but not limited to tuberculosis, significant bronchiectasis, established interstitial lung disease, and lung cancer. 4. History of serious comorbidities, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and could: 1. Affect the safety of the patient throughout the study, 2. Confound the study results or impact the scientific validity of the data outcome, 3. Impede the patient's ability to complete the entire duration of study. 5. Positive urine pregnancy test, or breastfeeding women, or any women who are planning to become pregnant (current and within 3 months). Prior/Concomitant Therapy 6. ICS-based medication (including ICS, ICS/LABA, ICS/LABA/LAMA) use within 3 months prior to enrollment (Day 0). ICS=inhaled corticosteroids; LABA=long-acting β2 agonists; LAMA=long-acting muscarinic antagonists. Other Exclusions 7. Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements. 8. Current participation in another interventional clinical trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
25 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Research Site
RECRUITINGBeijing, 100000, China
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Research Site
NOT_YET_RECRUITINGCangzhou, 061000, China
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Research Site
NOT_YET_RECRUITINGChangsha, 410008, China
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Research Site
RECRUITINGChangsha, 430033, China
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Research Site
NOT_YET_RECRUITINGChengdu, 610041, China
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Research Site
NOT_YET_RECRUITINGChongqing, 400016, China
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Research Site
RECRUITINGGuangzhou, 510000, China
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Research Site
NOT_YET_RECRUITINGGuangzhou, 510000, China
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Research Site
NOT_YET_RECRUITINGGuangzhou, 510120, China
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Research Site
RECRUITINGGuangzhou, 510630, China
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Research Site
NOT_YET_RECRUITINGKunming, 650032, China
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Research Site
RECRUITINGQuanzhou, 362000, China
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Research Site
NOT_YET_RECRUITINGShanghai, 200032, China
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Research Site
RECRUITINGShanghai, 200065, China
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Research Site
RECRUITINGShanghai, 200080, China
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Research Site
NOT_YET_RECRUITINGShanghai, 200433, China
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Research Site
NOT_YET_RECRUITINGSuzhou, 215006, China
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Research Site
RECRUITINGTaiyuan, 030001, China
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Research Site
NOT_YET_RECRUITINGTianjin, 300192, China
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Research Site
RECRUITINGÜrümqi, 830054, China
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Research Site
RECRUITINGWuhan, 430048, China
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Research Site
NOT_YET_RECRUITINGXi'an, 710004, China
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Research Site
NOT_YET_RECRUITINGYangzhou, 225001, China
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Research Site
RECRUITINGZhengzhou, 450000, China
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Research Site
RECRUITINGZhuhai, 519000, China
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