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.
Following the completion of informed consent procedures, patients with asthmatic symptoms will proceed to enrollment for inclusion and exclusion criteria review. In addition, blood tests, include complete blood count (CBC) and C-reactive protein (CRP), and chest Computed Tomography (CT) will be done for eligible participants prior to all assessments in the study to ensure excluding participants with respiratory infections and any lung diseases (other than asthma). All the included participants will undergo Fractional exhaled nitric oxide (FeNO) test, BDT with portable oscillometry and spirometry in sequence and complete the Asthma Control Questionnaire-5 (ACQ-5) assessment during Visit 1. For participants with pre-BD FEV1% ≥ 70% will undergo BPT with spirometry as the last assessment in the study. The diagnosis of asthma will be defined as positive BDT (after bronchodilator inhalation, FEV1 increased by ≥12%, and the absolute value of FEV1 increased by ≥200 mL) or positive BPT with spirometry (FEV1% decrease ≥20% after methacholine inhalation). Oscillometry BDT positive is defined as R5 decrease 40%, or X5 increase 50%, or AX decrease 80% after bronchodilator inhalation as recommended in ERS consensus.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
500
enrollment 500 suspect asthma patients
Research Site
Beijing, China
Research Site
Changsha, China
Research Site
Chengdu, China
To explore the diagnostic value of portable oscillometry in suspected asthma patients
PPV (Positive predictive value)(spiro diagnosed asthma/osci BDT ve+) of BDT(Bronchodilation test) with portable oscillomtery in asthma diagnosis
Time frame: day 0~7
To evaluate the consistency of portable oscillometry BD test with spirometry BDT/BPT in suspected asthma patients
Kappa coefficient between oscillometry BDT and spirometry BDT/BPT and NPV (non-asthma diagnosed by spiro/osci BDT ve-) of BDT with portable oscillometry in asthma diagnosis
Time frame: day 0~7
To evaluate the diagnostic performance of portable oscillometry in suspected asthma patients
Sensitivity (osci BDT ve+/spiro diagnosed asthma) and specificity (osci BDT ve-/non-asthma diagnosed by spiro) of BDT with portable oscillometry in asthma diagnosis. The proportion of osci BDT ve+ who have spiro BPT positive.
Time frame: day 0~7
To evaluate the diagnostic performance of spirometry in suspected asthma patients
Sensitivity (spiro BDT ve+/spiro diagnosed asthma) of BDT with spirometry in asthma diagnosis. The proportion of spiro BDT ve+ who have spiro BPT positive.
Time frame: day 0~7
To evaluate if performing BDT with spirometry and with oscillometry is superior to either test alone
The proportion of osci BDT ve+ who have spiro BDT positive. The proportion of osci BDT ve+ (excluding who have spiro BDT positive) who have spiro BPT positive. The number of asthma patients based on spiro BPT/BDT ve+, who have only osci BDT ve+ or spiro BDT ve+.
Time frame: day 0~7
To evaluate the diagnostic performance of portable oscillometry in asthma patients by lung functions impairment status
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Research Site
Chongqing, China
Research Site
Guangzhou, China
Research Site
Guangzhou, China
Research Site
Guangzhou, China
Research Site
Kunming, China
Research Site
Quanzhou, China
Research Site
Shanghai, China
...and 9 more locations
PPV and NPV of BDT with portable oscillometry in asthma patients with FEV1%≥70% and FEV1%\<70%, respectively.
Time frame: day 0~7
To explore the diagnostic value of single parameter or combination of parameters in asthma patients
Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) for individual or combination of any parameter of portable oscillometry together with or without FeNO and/or EOS in asthma diagnosis.
Time frame: day 0~7
To explore the diagnostic performance of BDT with portable oscillometry based on thresholds from other studies
The proportion of osci BDT ve+ according to the following thresholds reported in other studies. R5 decrease ≥32% or X5 increase ≥44% or AX decrease ≥65%. R5 decrease ≥29% or X5 increase ≥45%. Healthy population study in China.
Time frame: day 0~7
To describe the change in pulmonary function parameters measured by portable oscillometry before and after bronchodilator use in diagnosed asthma patients
Mean ± SD and percentile ranges (P₂.₅-P₉₇.₅) of the optimal oscillometry BDT variables (e.g., ΔRrs, ΔXrs, ΔAX) in diagnosed asthma patients.
Time frame: day 0~7