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Multicenter Study of Impulse Oscillometry in Chinese

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ClinicalTrials.gov Identifier: NCT03467880
Recruitment Status : Recruiting
First Posted : March 16, 2018
Last Update Posted : March 16, 2018
Sponsor:
Collaborators:
Beijing Hospital
Beijing Children's Hospital
Shanghai Zhongshan Hospital
Second Affiliated Hospital, School of Medicine, Zhejiang University
West China Hospital
Tongji Hospital
Third Military Medical University
Xiangya Hospital of Central South University
People's Hospital of Guizhou Province
Shanghai Pulmonary Hospital, Shanghai, China
Beijing Chao Yang Hospital
Information provided by (Responsible Party):
Jinping Zheng, Guangzhou Institute of Respiratory Disease

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).

Condition or disease Intervention/treatment
Healthy Subjects Chronic Obstructive Pulmonary Disease Asthma Interstitial Lung Disease Upper Airway Obstruction Other: Clinical Observation

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Multicenter Study of Impulse Oscillometry in Chinese
Study Start Date : September 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Airway resistance [ Time Frame: one minute ]
    The indices of Airway resistance include total respiratory impedance (Zrs).


Secondary Outcome Measures :
  1. forced vital capacity (FVC), forced expiratory volume in one second (FEV1), FEV1/FVC, and maximum midexpiratory flow (MMEF). [ Time Frame: one minute ]
    The indices of spirometry include forced vital capacity (FVC), forced expiratory volume in one second (FEV1), FEV1/FVC, and maximum midexpiratory flow (MMEF).



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 95 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Subjects will be recruited from outpatient clinics.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03467880


Contacts
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Contact: Jinping Zheng, MD +86-20-83062729 jpzhenggy@163.com

Locations
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China
Beijing Hospital Recruiting
Beijing, China, 100005
Contact: Yimeng Yang    +86 13911738389    d860@sina.com   
Principal Investigator: Tieying Sun         
Sub-Investigator: Yimeng Yang         
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 Not yet recruiting
Guangzhou, China, 510120
Contact: Jinping Zheng, MD    +86-20-83062729    jpzhenggy@163.com   
Sponsors and Collaborators
Guangzhou Institute of Respiratory Disease
Beijing Hospital
Beijing Children's Hospital
Shanghai Zhongshan Hospital
Second Affiliated Hospital, School of Medicine, Zhejiang University
West China Hospital
Tongji Hospital
Third Military Medical University
Xiangya Hospital of Central South University
People's Hospital of Guizhou Province
Shanghai Pulmonary Hospital, Shanghai, China
Beijing Chao Yang Hospital
Investigators
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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

Additional Information:

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Responsible Party: Jinping Zheng, Vice-director, Guangzhou Institute of Respiratory Disease
ClinicalTrials.gov Identifier: NCT03467880     History of Changes
Other Study ID Numbers: GIRD201536
First Posted: March 16, 2018    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: March 2018

Keywords provided by Jinping Zheng, Guangzhou Institute of Respiratory Disease:
Impulse Oscillometry
Chinese
Healthy Subjects
Chronic Obstructive Pulmonary Disease
Asthma
Interstitial Lung Disease
Upper Airway Obstruction
Reference Values

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Interstitial
Airway Obstruction
Respiratory Tract Diseases
Respiratory Insufficiency
Respiration Disorders