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.
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.
Study Type
OBSERVATIONAL
Enrollment
801
enrollment 200 asthma patients
enrollment 200 COPD patients
enrollment 200 patients
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.
Time frame: 30Dec2024
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
Time frame: 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
Time frame: 30Dec2024
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
Time frame: 30Dec2024
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enrollment 200 patients
Research Site
Beijing, China
Research Site
Changsha, China
Research Site
Chengdu, China
Research Site
Chongqing, China
Research Site
Dalian, China
Research Site
Fengcheng, China
Research Site
Fuyang, China
Research Site
Fuzhou, China
Research Site
Guangzhou, China
Research Site
Guiyang, China
...and 31 more locations