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

NCT ID: NCT06172777

Last Updated: 2025-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

801 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-08

Study Completion Date

2024-08-30

Brief Summary

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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

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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.

Conditions

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Asthma/ COPD

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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suspected asthma

enrollment 200 subjects

suspected asthma

Intervention Type DIAGNOSTIC_TEST

enrollment 200 asthma patients

Suspected COPD

enrollment 200 subjects

suspected COPD

Intervention Type DIAGNOSTIC_TEST

enrollment 200 COPD patients

confirmed asthma

enrollment 200 subjects

confirmed asthma

Intervention Type DIAGNOSTIC_TEST

enrollment 200 patients

confirmed COPD

enrollment 200 subjects.

confirmed COPD

Intervention Type DIAGNOSTIC_TEST

enrollment 200 patients

Interventions

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suspected asthma

enrollment 200 asthma patients

Intervention Type DIAGNOSTIC_TEST

suspected COPD

enrollment 200 COPD patients

Intervention Type DIAGNOSTIC_TEST

confirmed asthma

enrollment 200 patients

Intervention Type DIAGNOSTIC_TEST

confirmed COPD

enrollment 200 patients

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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 .
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Yulin, , China

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Yunnan, , China

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Zhaotong, , China

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Zhengzhou, , China

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Zhuji, , China

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Zigong, , China

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Beijing, , China

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Changsha, , China

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Chengdu, , China

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Chongqing, , China

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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

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Haikou, , China

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Hanchuan, , China

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Hangzhou, , China

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Haozhou, , China

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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

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Mianyang, , China

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Nanchang, , China

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Nantong, , China

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Ningbo, , China

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Ordos, , China

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Panzhou, , China

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Qionghai, , China

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Shanghai, , China

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Shenyang, , China

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Shenzhen, , China

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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

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Xinyang, , China

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Countries

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China

Other Identifiers

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D589BR00078

Identifier Type: -

Identifier Source: org_study_id

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