Clinical trial NCT03467880: Multicenter Study of Impulse Oscillometry in Chinese
Official title: Multicenter Study of Impulse Oscillometry in Chinese
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy Subjects
Chronic Obstructive Pulmonary Disease
Asthma
Interstitial Lung Disease
Upper Airway Obstruction
Keywords: Impulse Oscillometry
Chinese
Healthy Subjects
Chronic Obstructive Pulmonary Disease
Asthma
Interstitial Lung Disease
Upper Airway Obstruction
Reference Values
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
Collaborators: name: Beijing Hospital
name: Beijing Children's Hospital
name: Shanghai Zhongshan Hospital
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: West China Hospital
name: Tongji Hospital
name: Third Military Medical University
name: Xiangya Hospital of Central South University
name: People's Hospital of Anshun City of Guizhou Province
name: Shanghai Pulmonary Hospital, Shanghai, China
name: Beijing Chao Yang Hospital
First posted: 2018-03-16
Enrollment: 4000
Sex: ALL
Minimum age (years): 4
Maximum age (years): 95
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects will be recruited from outpatient clinics.

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Airway resistance
timeFrame: one minute
Secondary outcomes:
measure: forced vital capacity (FVC), forced expiratory volume in one second (FEV1), FEV1/FVC, and maximum midexpiratory flow (MMEF).
timeFrame: one minute
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital
city: Guangzhou
country: China
facility: 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
Study officials:
affiliation: 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
name: Jinping Zheng, MD
role: STUDY_CHAIR
References:
citation: 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.