Multicenter Study of Impulse Oscillometry in Chinese

Asthma Clinical Trial

Official title:

Multicenter Study of Impulse Oscillometry in Chinese

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03467880
• Other study ID #: GIRD201536
• 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
• 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

Related Conditions & MeSH terms

• Airway Obstruction
• Asthma
• Chronic Obstructive Pulmonary Disease
• Healthy Subjects
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Upper Airway Obstruction

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