Asthma/ COPD
Conditions
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTsuspected asthma
enrollment 200 asthma patients
DIAGNOSTIC_TESTsuspected COPD
enrollment 200 COPD patients
DIAGNOSTIC_TESTconfirmed asthma
enrollment 200 patients
DIAGNOSTIC_TESTconfirmed COPD
enrollment 200 patients
Sponsors
AstraZeneca
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 1. Participant must be≥18 years old. 2. 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 ≥40 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: 1. 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 2. Contraindication to spirometry or oscillometry test, or allergic to bronchodilator. 3. Currently pregnant or breast-feeding women 4. Judge by the investigator if the participant is unlikely to comply with study procedures, restrictions, and requirements, will not be enrolled .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Kappa coefficient of normal result and abnormal result between oscillometry and spirometry pre-BDT in the overall population. | 30Dec2024 | The consistency between oscillometry and spirometry results pre-bronchodilator test (BDT) in overall population. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare the time required from attempting to complete the test and number of attemptsB before completing the test. | 30Dec2024 | To compare the physician and patient acceptability to complete the first test of oscillometry and spirometry |
| Kappa coefficient of bronchodilator test positive result C between oscillometry and spirometry in the overall population. | 30Dec2024 | To evaluate the bronchodilator test result consistent of oscillometry with spirometry in overall population |
| Kappa coefficient of normal result and abnormal result between oscillometry and spirometry post-BDT in COPD group. | 30Dec2024 | The consistency between oscillometry and spirometry post-BDT results in COPD group |
Other
| Measure | Time frame | Description |
|---|---|---|
| The consistency between oscillometry parameters (R5, R5-R20,X5, AX fres) (normal,mild, moderate, severe)and FEV1 %pred(≤30%;30%-50%;50%-80%;≥80%) in preBDT | 30Dec2024 | To explore consistency between oscillometry parameters (R5, R5-R20,X5, AX fres) (normal,mild, moderate, severe)and FEV1 %pred(≤30%;30%-50%;50%-80%;≥80%) in pre-BDT |
| The consistency between oscillometry parameters (R5, R5-R20,X5, AX fres) (normal,mild, moderate, severe)and FEV1 %pred(≤30%;30%-50%;50%-80%;≥80%) in post BDT. | 30Dec2024 | To explore consistency between oscillometry parameters (R5, R5-R20,X5, AX fres) (normal,mild, moderate, severe)and FEV1 %pred(≤30%;30%-50%;50%-80%;≥80%) in post BDT |
| Characteristics of the population with consistent / inconsistent results from oscillometry and spirometry in BDT. | 30Dec2024 | To explore the characteristics of populations with consistent results between oscillometry and spirometry |
| To explore the characteristics of patients with small airway dysfunction defined by oscillometry and spirometry, and whether they are agreeing in detecting small airway dysfunction. | 30Dec2024 | To describe the characteristics of patients with small airway dysfunction using spirometry and oscillometry in the overall population, as well as the Kappa coefficient for detect small airway dysfunction between oscillometry and spirometry. |
| To explore the SAE/medical device deficiency related to ALDS or the investigational procedure | 30Dec2024 | SAE/medical device deficiency related to ALDS or the investigational procedure |
| To identify the joint predictors with the best diagnostic values for the diagnosis of COPD/asthma | 30Dec2024 | To identify the best joint predictors for the diagnosis of COPD/asthma |
| To explore the correlation of Asthma Control Questionnaire (ACQ-5) scores with spirometry and oscillometry parameters. | 30Dec2024 | To explore the parameters which can reflect asthma control better between oscillometry and spirometry in asthma patients |
| To explore the correlation of modified Medical Research Council (mMRC) scores with spirometry and oscillometry parameters | 30Dec2024 | To explore the parameters which can correlates better with symptom between oscillometry and spirometry in COPD patients |
| The predict value of oscillometry parameters including R5, R5-R20,X5, AX, fres, DX5 (X5 intra-breath) and DAX (AX intra-breath) pre bronchodilator test in differentiate between asthma and COPD | 30Dec2024 | To explore the predict value of oscillometry parameters includingR5, R5-R20, X5, AX, fres, DX5 (X5 intra-breath) and DAX (AX intra-breath) pre-bronchodilator test in differentiation between asthma and COPD |
Countries
China
Outcome results
None listed