Multicenter Study of Impulse Oscillometry in Chinese

The purpose of this study is to establish the reference values of impulse oscillometry (IOS) in healthy Chinese, and compare the indices of IOS in patients with lung disease, such as chronic obstructive pulmonary disease (COPD), asthma, interstitial lung disease (ILD), and upper airway Obstruction (UAO).

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease; Asthma; Healthy Subjects; Interstitial Lung Disease; Upper Airway Obstruction
• Intervention / Treatment: Other: Clinical Observation

• Study Type: Observational
• Enrollment (Anticipated): 4000

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100005
    • Recruiting
    • Beijing Hospital
    • Contact: Yimeng Yang; Phone Number: +86 13911738389; Email: d860@sina.com
    • Principal Investigator: Tieying Sun
    • Sub-Investigator: Yimeng Yang
  • Guangzhou, China, 510120
    • Not yet recruiting
    • State Key Laboratory of Respiratory Disease,China Clinical Research Center of Respiratory Disease, Guangzhou Institute of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical University
    • Contact: Jinping Zheng, MD; Phone Number: +86-20-83062729; Email: jpzhenggy@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 95 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects will be recruited from outpatient clinics.

Description

Inclusion Criteria for healthy subjects:

• life-long non-smokers
• no symptoms and history of chronic cardiopulmonary diseases (chronic bronchitis, asthma, lung cancer, pulmonary fibrosis, pulmonary tuberculosis, chronic heart diseases, etc.)
• no abnormal findings on physical examination
• written informed consent was obtained

Inclusion Criteria for COPD:

• Diagnosis of chronic obstructive pulmonary disease (COPD), as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines and post-bronchodilator FEV1/FVC (forced vital capacity) < 70%.

Inclusion Criteria for asthma:

• Diagnosis of asthma, as classified by national and international asthma guidelines.

Inclusion Criteria for ILD:

• ILD diagnosis confirmed by lung biopsy, X ray or BALF analysis.

Inclusion Criteria for UAO:

• Diagnosis of UAO.

Exclusion Criteria for healthy subjects:

• upper or lower respiratory infection within 4 weeks
• long-term exposure to harmful gas or particles
• using β-blocker for treatment
• pregnant women, epileptic
• other diseases or surgeries potentially affecting lung function

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy subjects; Healthy subjects.	Other: Clinical Observation; No treatment given but observation with IOS
Chronic obstructive pulmonary disease; Patience with chronic obstructive pulmonary disease.	Other: Clinical Observation; No treatment given but observation with IOS
Asthma; Patience with asthma.	Other: Clinical Observation; No treatment given but observation with IOS
Interstitial lung disease; Patience with interstitial lung disease.	Other: Clinical Observation; No treatment given but observation with IOS
Upper airway obstruction; Patience with upper airway obstruction.	Other: Clinical Observation; No treatment given but observation with IOS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Airway resistance	The indices of Airway resistance include total respiratory impedance (Zrs).	one minute

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
forced vital capacity (FVC), forced expiratory volume in one second (FEV1), FEV1/FVC, and maximum midexpiratory flow (MMEF).	The indices of spirometry include forced vital capacity (FVC), forced expiratory volume in one second (FEV1), FEV1/FVC, and maximum midexpiratory flow (MMEF).	one minute

Collaborators and Investigators

• Sponsor: Guangzhou Institute of Respiratory Disease
• Collaborators: Xiangya Hospital of Central South University; Shanghai Zhongshan Hospital; West China Hospital; Tongji Hospital; Second Affiliated Hospital, School of Medicine, Zhejiang University; Third Military Medical University; Beijing Chao Yang Hospital; Beijing Hospital; Shanghai Pulmonary Hospital, Shanghai, China; Beijing Children's Hospital; People's Hospital of Anshun City of Guizhou Province
• Investigators: Study Chair: Jinping Zheng, MD, State Key Laboratory of Respiratory Disease,China Clinical Research Center of Respiratory Disease, Guangzhou Institute of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical University

Publications and helpful links

General Publications

• Liang XL, Gao Y, Guan WJ, Du J, Chen L, Han W, Liu JM, Lu Y, Peng Y, Zhao BR, Wang T, Zheng JP. Reference values of respiratory impedance with impulse oscillometry in healthy Chinese adults. J Thorac Dis. 2021 Jun;13(6):3680-3691. doi: 10.21037/jtd-20-3376.

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: February 14, 2018
• First Submitted That Met QC Criteria: March 10, 2018
• First Posted (Actual): March 16, 2018

Study Record Updates

• Last Update Posted (Actual): March 16, 2018
• Last Update Submitted That Met QC Criteria: March 10, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Asthma; Chinese; Chronic Obstructive Pulmonary Disease; Healthy Subjects; Interstitial Lung Disease; Reference Values; Impulse Oscillometry; Upper Airway Obstruction
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Airway Obstruction; Lung Diseases, Interstitial
• Other Study ID Numbers: GIRD201536