Clinical trial NCT06172777: A Study to Evaluate the Consistency of Oscillometry and Spirometry Test Results in Patients With Confirmed or Suspected Asthma or COPD
Official title: A Study to Evaluate the Consistency of Oscillometry and Spirometry Test Results in Patients With Confirmed or Suspected Asthma or COPD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma/ COPD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2023-12-15
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Suspected and confirmed adult asthma and COPD patients.

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.

Eligibility criteria: 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 .

Primary outcomes:
measure: Kappa coefficient of normal result and abnormal result between oscillometry and spirometry pre-BDT in the overall population.
timeFrame: 30Dec2024
Secondary outcomes:
measure: Compare the time required from attempting to complete the test and number of attemptsB before completing the test.
timeFrame: 30Dec2024
measure: Kappa coefficient of bronchodilator test positive result C between oscillometry and spirometry in the overall population.
timeFrame: 30Dec2024
measure: Kappa coefficient of normal result and abnormal result between oscillometry and spirometry post-BDT in COPD group.
timeFrame: 30Dec2024
Other outcomes:
measure: Characteristics of the population with consistent / inconsistent results from oscillometry and spirometry in BDT.
timeFrame: 30Dec2024
measure: To explore the correlation of Asthma Control Questionnaire (ACQ-5) scores with spirometry and oscillometry parameters.
timeFrame: 30Dec2024
measure: To explore the correlation of modified Medical Research Council (mMRC) scores with spirometry and oscillometry parameters
timeFrame: 30Dec2024
measure: 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
timeFrame: 30Dec2024
measure: 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
timeFrame: 30Dec2024
measure: 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.
timeFrame: 30Dec2024
measure: To identify the joint predictors with the best diagnostic values for the diagnosis of COPD/asthma
timeFrame: 30Dec2024
measure: 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.
timeFrame: 30Dec2024
measure: To explore the SAE/medical device deficiency related to ALDS or the investigational procedure
timeFrame: 30Dec2024
Locations:
city: Beijing
country: China
facility: Research Site
city: Changsha
country: China
facility: Research Site
city: Chengdu
country: China
facility: Research Site
city: Chongqing
country: China
facility: Research Site
city: Dalian
country: China
facility: Research Site
city: Erdos
country: China
facility: Research Site
city: Fengcheng
country: China
facility: Research Site
city: Fuyang
country: China
facility: Research Site
city: Fuzhou
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Guiyang
country: China
facility: Research Site
city: Haikou
country: China
facility: Research Site
city: Hanchuan
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: Haozhou
country: China
facility: Research Site
city: Henan
country: China
facility: Research Site
city: Hong Kong
country: China
facility: Research Site
city: Jinan
country: China
facility: Research Site
city: Jingzhou
country: China
facility: Research Site
city: Kunming
country: China
facility: Research Site
city: Mianyang
country: China
facility: Research Site
city: Nanchang
country: China
facility: Research Site
city: Nantong
country: China
facility: Research Site
city: Ningbo
country: China
facility: Research Site
city: Panzhou
country: China
facility: Research Site
city: Qionghai
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shenyang
country: China
facility: Research Site
city: Shenzhen
country: China
facility: Research Site
city: Suining
country: China
facility: Research Site
city: Suzhou
country: China
facility: Research Site
city: Taiyuan
country: China
facility: Research Site
city: Taizhou
country: China
facility: Research Site
city: Tianjin
country: China
facility: Research Site
city: Xinyang
country: China
facility: Research Site
city: Yulin
country: China
facility: Research Site
city: Yunnan
country: China
facility: Research Site
city: Zhaotong
country: China
facility: Research Site
city: Zhengzhou
country: China
facility: Research Site
city: Zhuji
country: China
facility: Research Site
city: Zigong
country: China
facility: Research Site
Study officials:
References: