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Completed

NCT Number: NCT06172777

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

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.

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Key information

Conditions

Asthma/ COPD

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Beijing, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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 criteria

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 .

Treatment and study plan

suspected asthma

Diagnostic Test

enrollment 200 asthma patients

suspected COPD

Diagnostic Test

enrollment 200 COPD patients

confirmed asthma

Diagnostic Test

enrollment 200 patients

confirmed COPD

Diagnostic Test

enrollment 200 patients

Primary outcomes

  1. 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.

Secondary outcomes

  1. Compare the time required from attempting to complete the test and number of attemptsB before completing the test.

    Time frame: 30Dec2024

    To compare the physician and patient acceptability to complete the first test of oscillometry and spirometry

  2. Kappa coefficient of bronchodilator test positive result C between oscillometry and spirometry in the overall population.

    Time frame: 30Dec2024

    To evaluate the bronchodilator test result consistent of oscillometry with spirometry in overall population

  3. Kappa coefficient of normal result and abnormal result between oscillometry and spirometry post-BDT in COPD group.

    Time frame: 30Dec2024

    The consistency between oscillometry and spirometry post-BDT results in COPD group

Other outcomes

  1. Characteristics of the population with consistent / inconsistent results from oscillometry and spirometry in BDT.

    Time frame: 30Dec2024

    To explore the characteristics of populations with consistent results between oscillometry and spirometry

  2. To explore the correlation of Asthma Control Questionnaire (ACQ-5) scores with spirometry and oscillometry parameters.

    Time frame: 30Dec2024

    To explore the parameters which can reflect asthma control better between oscillometry and spirometry in asthma patients

  3. To explore the correlation of modified Medical Research Council (mMRC) scores with spirometry and oscillometry parameters

    Time frame: 30Dec2024

    To explore the parameters which can correlates better with symptom between oscillometry and spirometry in COPD patients

  4. The predict value of oscillometry parameters including R5, R5-R20,X5, AX, fres, DX5 (X5 intra-breath) and DAX (AX intra-breath) pre bronchodilator test in differentiate between asthma and COPD

    Time frame: 30Dec2024

    To explore the predict value of oscillometry parameters includingR5, R5-R20, X5, AX, fres, DX5 (X5 intra-breath) and DAX (AX intra-breath) pre-bronchodilator test in differentiation between asthma and COPD

  5. The consistency between oscillometry parameters (R5, R5-R20,X5, AX fres) (normal,mild, moderate, severe)and FEV1 %pred(≤30%;30%-50%;50%-80%;≥80%) in preBDT

    Time frame: 30Dec2024

    To explore consistency between oscillometry parameters (R5, R5-R20,X5, AX fres) (normal,mild, moderate, severe)and FEV1 %pred(≤30%;30%-50%;50%-80%;≥80%) in pre-BDT

  6. The consistency between oscillometry parameters (R5, R5-R20,X5, AX fres) (normal,mild, moderate, severe)and FEV1 %pred(≤30%;30%-50%;50%-80%;≥80%) in post BDT.

    Time frame: 30Dec2024

    To explore consistency between oscillometry parameters (R5, R5-R20,X5, AX fres) (normal,mild, moderate, severe)and FEV1 %pred(≤30%;30%-50%;50%-80%;≥80%) in post BDT

  7. To identify the joint predictors with the best diagnostic values for the diagnosis of COPD/asthma

    Time frame: 30Dec2024

    To identify the best joint predictors for the diagnosis of COPD/asthma

  8. To explore the characteristics of patients with small airway dysfunction defined by oscillometry and spirometry, and whether they are agreeing in detecting small airway dysfunction.

    Time frame: 30Dec2024

    To describe the characteristics of patients with small airway dysfunction using spirometry and oscillometry in the overall population, as well as the Kappa coefficient for detect small airway dysfunction between oscillometry and spirometry.

  9. To explore the SAE/medical device deficiency related to ALDS or the investigational procedure

    Time frame: 30Dec2024

    SAE/medical device deficiency related to ALDS or the investigational procedure

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Acronym: IOS

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 15, 2023
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.