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Multicenter Study of Impulse Oscillometry in Chinese

G

Guangzhou Institute of Respiratory Disease

Status

Unknown

Conditions

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

Treatments

Other: Clinical Observation

Study type

Observational

Funder types

Other

Identifiers

NCT03467880
GIRD201536

Details and patient eligibility

About

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).

Enrollment

4,000 estimated patients

Sex

All

Ages

4 to 95 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

4,000 participants in 5 patient groups

Healthy subjects
Description:
Healthy subjects.
Treatment:
Other: Clinical Observation
Chronic obstructive pulmonary disease
Description:
Patience with chronic obstructive pulmonary disease.
Treatment:
Other: Clinical Observation
Asthma
Description:
Patience with asthma.
Treatment:
Other: Clinical Observation
Interstitial lung disease
Description:
Patience with interstitial lung disease.
Treatment:
Other: Clinical Observation
Upper airway obstruction
Description:
Patience with upper airway obstruction.
Treatment:
Other: Clinical Observation

Trial contacts and locations

2

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Central trial contact

Jinping Zheng, MD

Data sourced from clinicaltrials.gov

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