A Study to Evaluate the Consistency of Oscillometry and Spirometry Test Results in Patients With Confirmed or Suspected Asthma or COPD
IOS
1 other identifier
observational
801
1 country
41
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2024
Shorter than P25 for all trials
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2023
CompletedFirst Posted
Study publicly available on registry
December 15, 2023
CompletedStudy Start
First participant enrolled
February 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2024
CompletedJuly 24, 2025
July 1, 2025
7 months
December 7, 2023
July 21, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Compare the time required from attempting to complete the test and number of attemptsB before completing the test.
30Dec2024
Kappa coefficient of bronchodilator test positive result C between oscillometry and spirometry in the overall population.
30Dec2024
Kappa coefficient of normal result and abnormal result between oscillometry and spirometry post-BDT in COPD group.
30Dec2024
Other Outcomes (9)
Characteristics of the population with consistent / inconsistent results from oscillometry and spirometry in BDT.
30Dec2024
To explore the correlation of Asthma Control Questionnaire (ACQ-5) scores with spirometry and oscillometry parameters.
30Dec2024
To explore the correlation of modified Medical Research Council (mMRC) scores with spirometry and oscillometry parameters
30Dec2024
- +6 more other outcomes
Study Arms (4)
suspected asthma
enrollment 200 subjects
Suspected COPD
enrollment 200 subjects
confirmed asthma
enrollment 200 subjects
confirmed COPD
enrollment 200 subjects.
Interventions
Eligibility Criteria
Suspected and confirmed adult asthma and COPD patients.
You may qualify if:
- 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
- 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)
You may not qualify if:
- 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 .
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (41)
Research Site
Beijing, China
Research Site
Changsha, China
Research Site
Chengdu, China
Research Site
Chongqing, China
Research Site
Dalian, China
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Fengcheng, China
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Fuyang, China
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Fuzhou, China
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Guangzhou, China
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Guiyang, China
Research Site
Haikou, China
Research Site
Hanchuan, China
Research Site
Hangzhou, China
Research Site
Haozhou, China
Research Site
Henan, China
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Hong Kong, China
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Jinan, China
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Jingzhou, China
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Kunming, China
Research Site
Mianyang, China
Research Site
Nanchang, China
Research Site
Nantong, China
Research Site
Ningbo, China
Research Site
Ordos, China
Research Site
Panzhou, China
Research Site
Qionghai, China
Research Site
Shanghai, China
Research Site
Shenyang, China
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Shenzhen, China
Research Site
Suining, China
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Suzhou, China
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Taiyuan, China
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Taizhou, China
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Tianjin, China
Research Site
Xinyang, China
Research Site
Yulin, China
Research Site
Yunnan, China
Research Site
Zhaotong, China
Research Site
Zhengzhou, China
Research Site
Zhuji, China
Research Site
Zigong, China
Related Links
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2023
First Posted
December 15, 2023
Study Start
February 8, 2024
Primary Completion
August 30, 2024
Study Completion
August 30, 2024
Last Updated
July 24, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP