Multicenter Study of Impulse Oscillometry in Chinese

NCT03467880 | Unknown DMC

• 1 other identifier: GIRD201536
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 2

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).

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

Outcome Measures

Primary Outcomes (1)

• Airway resistance

  The indices of Airway resistance include total respiratory impedance (Zrs).

  one minute

Secondary Outcomes (1)

• forced vital capacity (FVC), forced expiratory volume in one second (FEV1), FEV1/FVC, and maximum midexpiratory flow (MMEF).

  one minute

Study Arms (5)

Healthy subjects

Healthy subjects.

Other: Clinical Observation

Chronic obstructive pulmonary disease

Patience with chronic obstructive pulmonary disease.

Other: Clinical Observation

Asthma

Patience with asthma.

Other: Clinical Observation

Interstitial lung disease

Patience with interstitial lung disease.

Other: Clinical Observation

Upper airway obstruction

Patience with upper airway obstruction.

Other: Clinical Observation

Interventions

Clinical Observation OTHER

No treatment given but observation with IOS

Asthma; Chronic obstructive pulmonary disease; Healthy subjects; Interstitial lung disease; Upper airway obstruction

Eligibility Criteria

• Age: 4 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects will be recruited from outpatient clinics.

You may qualify if:

• 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
• 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%.
• Diagnosis of asthma, as classified by national and international asthma guidelines.
• ILD diagnosis confirmed by lung biopsy, X ray or BALF analysis.
• Diagnosis of UAO.

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead
• Beijing Hospital: collaborator
• Beijing Children's Hospital: collaborator
• Shanghai Zhongshan Hospital: collaborator
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator
• West China Hospital: collaborator
• Tongji Hospital: collaborator
• Third Military Medical University: collaborator
• Xiangya Hospital of Central South University: collaborator
• People's Hospital of Anshun City of Guizhou Province: collaborator
• Shanghai Pulmonary Hospital, Shanghai, China: collaborator
• Beijing Chao Yang Hospital: collaborator

Study Sites (2)

Beijing Hospital

Beijing, 100005, China

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

Guangzhou, 510120, China

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 34277060 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma; Lung Diseases, Interstitial; Airway Obstruction

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiratory Insufficiency; Respiration Disorders

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• 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

  STUDY CHAIR

Central Study Contacts

Jinping Zheng, MD

CONTACT

+86-20-83062729; jpzhenggy@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-director

Study Record Dates

• First Submitted: February 14, 2018
• First Posted: March 16, 2018
• Study Start: September 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 16, 2018

Record last verified: 2018-03

Locations

CN (2)