A Study to Evaluate the Consistency of Oscillometry and Spirometry Test Results in Patients With Confirmed or Suspected Asthma or COPD

Recruiting

• Conditions: Asthma/ COPD
• Interventions: Diagnostic Test: suspected asthma; Diagnostic Test: suspected COPD; Diagnostic Test: confirmed COPD; Diagnostic Test: confirmed asthma

• Registration Number: NCT06172777
• Lead Sponsor: AstraZeneca

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.

Study Timeline

• Study First Submitted: 2023-12-07
• Study First Submitted QC: 2023-12-07
• Study First Posted: 2023-12-15
• Study Start: 2024-01-29
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-22
• Primary Completion: 2024-08-30
• Study Completion: 2024-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

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 .

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
suspected asthma	suspected asthma	enrollment 200 subjects
Suspected COPD	suspected COPD	enrollment 200 subjects
confirmed COPD	confirmed COPD	enrollment 200 subjects.
confirmed asthma	confirmed asthma	enrollment 200 subjects

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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
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

Trial Locations

Locations (1)

Research Site; 🇨🇳 Zigong, China