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Clinical Trials in China / NCT07516184
Recruiting Not applicable

Explore the Diagnostic Value of Bronchodilation Test With Portable Oscillometry in Asthma Diagnosis

NCT07516184 · tracked via the Priya Life Science China tracker
Sponsor
AstraZeneca
Phase
Not applicable
Started
2026-06-10
Last updated
2026-09-14

Condition(s) studied

Suspected Asthma

Investigational drug(s) / intervention(s)

Pulmonary function Test intervention

Pulmonary function Test intervention: enrollment 500 suspect asthma patients

Study summary

This is a multi-center study to explore the positive predictive value of bronchodilation test with portable oscillometry compared to either BDT or BPT with spirometry in asthma diagnosis and to compare it with bronchodilation with spirometry (the current gold standard). In the study, the target patients' profile is the suspected asthma patient with asthmatic symptoms (wheezing, shortness of breath, chest tightness, and/or cough) and aim to enroll 500 participants from 25 sites across different regions in China.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (25)

FacilityCityRegionStatus
Research Site Beijing China Recruiting
Research Site Cangzhou China Not Yet Recruiting
Research Site Changsha China Not Yet Recruiting
Research Site Changsha China Recruiting
Research Site Chengdu China Not Yet Recruiting
Research Site Chongqing China Not Yet Recruiting
Research Site Guangzhou China Recruiting
Research Site Guangzhou China Not Yet Recruiting
Research Site Guangzhou China Not Yet Recruiting
Research Site Guangzhou China Recruiting
Research Site Kunming China Not Yet Recruiting
Research Site Quanzhou China Recruiting
Research Site Shanghai China Not Yet Recruiting
Research Site Shanghai China Recruiting
Research Site Shanghai China Recruiting
Research Site Shanghai China Not Yet Recruiting
Research Site Suzhou China Not Yet Recruiting
Research Site Taiyuan China Recruiting
Research Site Tianjin China Not Yet Recruiting
Research Site Ürümqi China Recruiting
Research Site Wuhan China Recruiting
Research Site Xi'an China Not Yet Recruiting
Research Site Yangzhou China Not Yet Recruiting
Research Site Zhengzhou China Recruiting
Research Site Zhuhai China Recruiting

More AstraZeneca trials in China

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 NCT07516184 on ClinicalTrials.gov ↗ ← All trials in China