Status:
COMPLETED
A Study to Evaluate the Consistency of Oscillometry and Spirometry Test Results in Patients With Confirmed or Suspected Asthma or COPD
Lead Sponsor:
AstraZeneca
Conditions:
Asthma/ COPD
Eligibility:
All Genders
18+ years
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 In...
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:...
Eligibility Criteria
Inclusion
- 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 ≥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
- 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 .
Key Trial Info
Start Date :
February 8 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 30 2024
Estimated Enrollment :
801 Patients enrolled
Trial Details
Trial ID
NCT06172777
Start Date
February 8 2024
End Date
August 30 2024
Last Update
July 24 2025
Active Locations (41)
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1
Research Site
Beijing, China
2
Research Site
Changsha, China
3
Research Site
Chengdu, China
4
Research Site
Chongqing, China