Asthma/ COPDIOSNCT06172777
A Study to Evaluate the Consistency of Oscillometry and Spirometry Test Results in Patients With Confirmed or Suspected Asthma or COPD
An observational study of Asthma/ COPD, run by AstraZeneca at 41 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma/ COPD
- What is being tested?
- suspected asthma, suspected COPD and confirmed asthma
- How many people
- 801 participants
- Where
- 41 sitesChina
- Study dates
- 8 Feb 2024to 30 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Suspected and confirmed adult asthma and COPD patients.
Who may be able to join
- 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)
Who cannot join
- 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 .
Trial locations and contacts
41 sites in 1 country.
41 sites in 1 country
China41 sites
Research Site
Beijing
Research Site
Changsha
Research Site
Chengdu
Research Site
Chongqing
Research Site
Dalian
Research Site
Fengcheng
Research Site
Fuyang
Research Site
Fuzhou
Research Site
Guangzhou
Research Site
Guiyang
Research Site
Haikou
Research Site
Hanchuan
Research Site
Hangzhou
Research Site
Haozhou
Research Site
Henan
Research Site
Hong Kong
Research Site
Jinan
Research Site
Jingzhou
Research Site
Kunming
Research Site
Mianyang
Research Site
Nanchang
Research Site
Nantong
Research Site
Ningbo
Research Site
Ordos
Research Site
Panzhou
Research Site
Qionghai
Research Site
Shanghai
Research Site
Shenyang
Research Site
Shenzhen
Research Site
Suining
Research Site
Suzhou
Research Site
Taiyuan
Research Site
Taizhou
Research Site
Tianjin
Research Site
Xinyang
Research Site
Yulin
Research Site
Yunnan
Research Site
Zhaotong
Research Site
Zhengzhou
Research Site
Zhuji
Research Site
Zigong
About this study
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.
Read the 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.
- Conditions
- Asthma/ COPD
- Being tested
- suspected asthma, suspected COPD, confirmed asthma, confirmed COPD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suspected asthmaDiagnostic test
enrollment 200 asthma patients
suspected COPDDiagnostic test
enrollment 200 COPD patients
confirmed asthmaDiagnostic test
enrollment 200 patients
confirmed COPDDiagnostic test
enrollment 200 patients
| Study group | Role | What they receive |
|---|---|---|
| suspected asthma | enrollment 200 subjects Receives: Diagnostic Test: suspected asthma | |
| Suspected COPD | enrollment 200 subjects Receives: Diagnostic Test: suspected COPD | |
| confirmed asthma | enrollment 200 subjects Receives: Diagnostic Test: confirmed asthma | |
| confirmed COPD | enrollment 200 subjects. Receives: Diagnostic Test: confirmed COPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30Dec2024
Secondary outcomes (3)
Compare the time required from attempting to complete the test and number of attemptsB before completing the test.
To compare the physician and patient acceptability to complete the first test of oscillometry and spirometry
Measured: 30Dec2024
Kappa coefficient of bronchodilator test positive result C between oscillometry and spirometry in the overall population.
To evaluate the bronchodilator test result consistent of oscillometry with spirometry in overall population
Measured: 30Dec2024
Kappa coefficient of normal result and abnormal result between oscillometry and spirometry post-BDT in COPD group.
The consistency between oscillometry and spirometry post-BDT results in COPD group
Measured: 30Dec2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start8 Feb 2024
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asthma/ COPDStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 801 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172777
- Sponsor's protocol ID
- D589BR00078
- Acronym
- IOS
- Status last verified
- Jul 2025
- First submitted
- 7 Dec 2023
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Niu H, Rong X, Zhang M, Deng F, Zhang L, Li Y, Gao Y, Harrison T, Bardsley S, Song Y, Huang K, Yang T, Wang C. Consistency Between Oscillometry and Spirometry in Patients with Suspected or Confirmed COPD or Asthma: Results from a Multi-Center Study in China. COPD. 2026 Dec;23(1):2617284. doi: 10.1080/15412555.2026.2617284. Epub 2026 Mar 20.
PubMed 41860428
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Consistency of Oscillometry and Spirometry Test Results in Patients With Confirmed or Suspected Asthma or COPD
- ClinicalTrials.gov ID
- NCT06172777
- Acronym / sponsor ID
- IOS / D589BR00078
- Conditions
- Asthma/ COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 801 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 15 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| suspected asthma | – | Diagnostic Test: suspected asthmaenrollment 200 subjects |
| Suspected COPD | – | Diagnostic Test: suspected COPDenrollment 200 subjects |
| confirmed asthma | – | Diagnostic Test: confirmed asthmaenrollment 200 subjects |
| confirmed COPD | – | Diagnostic Test: confirmed COPDenrollment 200 subjects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Suspected and confirmed adult asthma and COPD patients.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| suspected asthmaenrollment 200 asthma patients | Diagnostic test | suspected asthma |
| suspected COPDenrollment 200 COPD patients | Diagnostic test | Suspected COPD |
| confirmed asthmaenrollment 200 patients | Diagnostic test | confirmed asthma |
| confirmed COPDenrollment 200 patients | Diagnostic test | confirmed COPD |
Primary outcome
Kappa coefficient of normal result and abnormal result between oscillometry and spirometry pre-BDT in the overall population.
Time frame: 30Dec2024
The consistency between oscillometry and spirometry results pre-bronchodilator test (BDT) in overall population.
3 secondary outcomes
Compare the time required from attempting to complete the test and number of attemptsB before completing the test.
Time frame: 30Dec2024
Kappa coefficient of bronchodilator test positive result C between oscillometry and spirometry in the overall population.
Time frame: 30Dec2024
Kappa coefficient of normal result and abnormal result between oscillometry and spirometry post-BDT in COPD group.
Time frame: 30Dec2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Derived from this study: PubMed 41860428Niu H, Rong X, Zhang M, Deng F, Zhang L, Li Y, Gao Y, Harrison T, Bardsley S, Song Y, Huang K, Yang T, Wang C. Consistency Between Oscillometry and Spirometry in Patients with Suspected or Confirmed COPD or Asthma: Results from a Multi-Center Study in China. COPD. 2026 Dec;23(1):2617284. doi: 10.1080/15412555.2026.2617284. Epub 2026 Mar 20.
- CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
41 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma/ COPD, run by AstraZeneca at 41 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kappa coefficient of normal result and abnormal result between oscillometry and spirometry pre-BDT in the overall population. (time frame: 30Dec2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06172777, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.