Bronchodilation Test with Portable Oscillometry for Asthma Diagnosis

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 multi-center study in China enrolls up to 500 adults with suspected asthma to compare a bronchodilation test using portable oscillometry against the standard bronchodilation tests with spirometry. Participants undergo FeNO, portable oscillometry bronchodilation testing, and spirometry, plus ACQ-5 before any intervention; those with adequate baseline lung function may receive an additional bronchodilation test with spirometry. Diagnosis of asthma is defined by specific positive responses to bronchodilation tests according to established thresholds, with care taken to exclude other lung diseases through pre-test imaging and labs. The study is led by AstraZeneca with multiple Beijing-area sites and aims to clarify the diagnostic value of portable oscillometry in routine practice.

Why it matters

Who can join: the full rules

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.

Where it's running

• Research Site
  Beijing, China Recruiting
• Research Site
  Cangzhou, China Recruiting
• Research Site
  Changsha, China Recruiting
• Research Site
  Chengdu, China Recruiting
• Research Site
  Chongqing, China Recruiting
• Research Site
  Guangzhou, China Recruiting

Study contacts

• Principal investigator: KeWu Huang, Doctor — Beijing Chao-Yang Hospital, 8 Gongren Tiyuchang Nanlu, Chaoyang District, Beijing, China
• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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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.