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

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.

Study Overview

• Status: Recruiting
• Conditions: Asthma/ COPD
• Intervention / Treatment: Diagnostic test: suspected asthma; Diagnostic test: suspected COPD; Diagnostic test: confirmed asthma; Diagnostic test: confirmed COPD

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 Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Research Site
  • Beijing, China
    • Not yet recruiting
    • Research Site
  • Changsha, China
    • Not yet recruiting
    • Research Site
  • Chengdu, China
    • Not yet recruiting
    • Research Site
  • Chongqing, China
    • Not yet recruiting
    • Research Site
  • Dalian, China
    • Not yet recruiting
    • Research Site
  • Erdos, China
    • Not yet recruiting
    • Research Site
  • Fengcheng, China
    • Not yet recruiting
    • Research Site
  • Fuyang, China
    • Not yet recruiting
    • Research Site
  • Fuzhou, China
    • Not yet recruiting
    • Research Site
  • Guangzhou, China
    • Not yet recruiting
    • Research Site
  • Guiyang, China
    • Not yet recruiting
    • Research Site
  • Haikou, China
    • Not yet recruiting
    • Research Site
  • Hanchuan, China
    • Not yet recruiting
    • Research Site
  • Hangzhou, China
    • Not yet recruiting
    • Research Site
  • Haozhou, China
    • Not yet recruiting
    • Research Site
  • Henan, China
    • Not yet recruiting
    • Research Site
  • Jinan, China
    • Not yet recruiting
    • Research Site
  • Jingzhou, China
    • Not yet recruiting
    • Research Site
  • Kunming, China
    • Not yet recruiting
    • Research Site
  • Mianyang, China
    • Recruiting
    • Research Site
  • Nanchang, China
    • Not yet recruiting
    • Research Site
  • Nantong, China
    • Not yet recruiting
    • Research Site
  • Ningbo, China
    • Recruiting
    • Research Site
  • Panzhou, China
    • Not yet recruiting
    • Research Site
  • Qionghai, China
    • Not yet recruiting
    • Research Site
  • Shanghai, China
    • Not yet recruiting
    • Research Site
  • Shenyang, China
    • Not yet recruiting
    • Research Site
  • Shenzhen, China
    • Not yet recruiting
    • Research Site
  • Suining, China
    • Recruiting
    • Research Site
  • Suzhou, China
    • Not yet recruiting
    • Research Site
  • Taiyuan, China
    • Not yet recruiting
    • Research Site
  • Taizhou, China
    • Not yet recruiting
    • Research Site
  • Tianjin, China
    • Not yet recruiting
    • Research Site
  • Xinyang, China
    • Not yet recruiting
    • Research Site
  • Yulin, China
    • Not yet recruiting
    • Research Site
  • Yunnan, China
    • Not yet recruiting
    • Research Site
  • Zhaotong, China
    • Not yet recruiting
    • Research Site
  • Zhengzhou, China
    • Not yet recruiting
    • Research Site
  • Zhuji, China
    • Not yet recruiting
    • Research Site
  • Zigong, China
    • Not yet recruiting
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Suspected and confirmed adult asthma and COPD patients.

Description

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 ≥45 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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
suspected asthma; enrollment 200 subjects	Diagnostic test: suspected asthma; enrollment 200 asthma patients
Suspected COPD; enrollment 200 subjects	Diagnostic test: suspected COPD; enrollment 200 COPD patients
confirmed asthma; enrollment 200 subjects	Diagnostic test: confirmed asthma; enrollment 200 patients
confirmed COPD; enrollment 200 subjects.	Diagnostic test: confirmed COPD; enrollment 200 patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30Dec2024

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	31Dec2024
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	30Dec2024

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characteristics of the population with consistent / inconsistent results from oscillometry and spirometry in BDT.	To explore the characteristics of populations with consistent results between oscillometry and spirometry	30Dec2024
To explore the correlation of Asthma Control Questionnaire (ACQ-5) scores with spirometry and oscillometry parameters.	To explore the parameters which can reflect asthma control better between oscillometry and spirometry in asthma patients	30Dec2024
To explore the correlation of modified Medical Research Council (mMRC) scores with spirometry and oscillometry parameters	To explore the parameters which can correlates better with symptom between oscillometry and spirometry in COPD patients	30Dec2023
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	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	30Dec2024
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	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	30Dec2024
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.	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	30Dec2024

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2024
• Primary Completion (Estimated): August 9, 2024
• Study Completion (Estimated): August 9, 2024

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: December 7, 2023
• First Posted (Actual): December 15, 2023

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: D589BR00078

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No