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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03467880
Other study ID # GIRD201536
Secondary ID
Status Recruiting
Phase N/A
First received February 14, 2018
Last updated March 10, 2018
Start date September 2016
Est. completion date December 2018

Study information

Verified date March 2018
Source Guangzhou Institute of Respiratory Disease
Contact Jinping Zheng, MD
Phone +86-20-83062729
Email jpzhenggy@163.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 4000
Est. completion date December 2018
Est. primary completion date June 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 95 Years
Eligibility 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 ß-blocker for treatment

- pregnant women, epileptic

- other diseases or surgeries potentially affecting lung function

Study Design


Intervention

Other:
Clinical Observation
No treatment given but observation with IOS

Locations

Country Name City State
China Beijing Hospital Beijing
China 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

Sponsors (12)

Lead Sponsor Collaborator
Guangzhou Institute of Respiratory Disease Beijing Chao Yang Hospital, Beijing Children's Hospital, Beijing Hospital, People's Hospital of Guizhou Province, Second Affiliated Hospital, School of Medicine, Zhejiang University, Shanghai Pulmonary Hospital, Shanghai, China, Shanghai Zhongshan Hospital, Third Military Medical University, Tongji Hospital, West China Hospital, Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Airway resistance The indices of Airway resistance include total respiratory impedance (Zrs). one minute
Secondary 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
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