A Study to Evaluate the Consistency of Oscillometry and Spirometry Test Results in Patients With Confirmed or Suspected Asthma or COPD

Study Overview
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Brief Summary
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The study to evaluate the consistency of oscillometry and spirometry test results in patients with confirmed or suspected asthma or COPD, it is a multi-centre clinical study. sponsor by Astrazeneca Investment(China) Co.,LTD.

Detailed Description
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800 patients, including suspected or confirmed asthma, suspected or confirmed COPD, will be enrolled in nationwide multiple study centres. Enrolling suspected and confirmed subject in an approximate1:1 rate in centre-level. About 100 subjects were enrolled at the leader site, while about 14 subjects were enrolled at other sites. To evaluate the consistency of oscillometry and spirometry test results in patients with confirmed or suspected asthma or COPD.

Official Title
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A Study to Evaluate the Consistency of Oscillometry and Spirometry Test Results in Patients With Confirmed or Suspected Asthma or COPD

Conditions
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Asthma/ COPD

Intervention / Treatment
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* Diagnostic Test: suspected asthma
* Diagnostic Test: suspected COPD
* Diagnostic Test: confirmed asthma
* Diagnostic Test: confirmed COPD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply and signed informed content : Suspected and confirmed asthma Participant must be≥18 years old. Present symptom such as wheezing, cough, chest tightness, shortness of breath, but not confirmed-asthma (without evidence of variable airflow restriction) or confirmed-asthma with evidence of variable airflow restriction (such as positive bronchodilation test, positive bronchial challenge test, variability >10% in twice daily PEF over 2 weeks, et al) Suspected and confirmed COPD 1 Participant must be ≥45 years old. 2 Present symptom such as chronic cough, sputum production, dyspnoea, but not confirmed-COPD (without evidence of persistent airflow restriction) or confirmed- COPD with evidence of persistent airflow restriction (post-bronchodilator FEV1/FVC<0.7) Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: Any diseases that influence lung function result such as lung cancer, pneumonia, active pulmonary tuberculosis, pulmonary embolism and interstitial lung disease, etc; history of recent surgery that affect lung function results, including thoracotomy surgery, pneumothorax surgery, thoracic drainage, etc Contraindication to spirometry or oscillometry test, or allergic to bronchodilator. Currently pregnant or breast-feeding women Judge by the investigator if the participant is unlikely to comply with study procedures, restrictions, and requirements, will not be enrolled .
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| suspected asthma<br>enrollment 200 subjects | Diagnostic Test: suspected asthma<br>* enrollment 200 asthma patients<br>|
| Suspected COPD<br>enrollment 200 subjects | Diagnostic Test: suspected COPD<br>* enrollment 200 COPD patients<br>|
| confirmed asthma<br>enrollment 200 subjects | Diagnostic Test: confirmed asthma<br>* enrollment 200 patients<br>|
| confirmed COPD<br>enrollment 200 subjects. | Diagnostic Test: confirmed COPD<br>* enrollment 200 patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kappa coefficient of normal result and abnormal result between oscillometry and spirometry pre-BDT in the overall population. | The consistency between oscillometry and spirometry results pre-bronchodilator test (BDT) in overall population. | 30Dec2024 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the time required from attempting to complete the test and number of attemptsB before completing the test. | To compare the physician and patient acceptability to complete the first test of oscillometry and spirometry | 30Dec2024 | 
| Kappa coefficient of bronchodilator test positive result C between oscillometry and spirometry in the overall population. | To evaluate the bronchodilator test result consistent of oscillometry with spirometry in overall population | 31Dec2024 | 
| Kappa coefficient of normal result and abnormal result between oscillometry and spirometry post-BDT in COPD group. | The consistency between oscillometry and spirometry post-BDT results in COPD group | 30Dec2024 |