COPD
Conditions
Interventions
Emphysema predominant phenotype of COPD:Only bronchodilators or ICS & bronchodilators
Bronchitis predominant phenotype of COPD:Only bronchodilators or ICS & bronchodilators
Sponsors
Qilu Hospital, Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for stable COPD patients 1. Aged over 18 years male and female; 2. FEV1/FVC<70% after inhaling bronchodilator; 3. The patient was at a stable stage, and had no respiratory infection and acute exacerbation of COPD within 4 weeks; 4. No antibiotics were used within 30 days prior to screening. Inclusion criteria for people at high risk of COPD: 1. Aged over 18 years male and female; 2. Smoking history: over 20 pack-years; 3. Pulmonary function: no obstructive pulmonary dysfunction was observed at the beginning of the study according to the pulmonary function guidelines of the Respiratory Society, Chinese Medical Association; 4. No history of chronic disease or respiratory diseases such as lung cancer, bronchiectasis, interstitial lung disease, asthma, etc; 5. No other serious system diseases,and life expectancy is more than one year; 6. No antibiotics were used within 30 days prior to screening; Inclusion criteria for healthy non-smoker: 1. Aged over 18 years male and female; 2. Healthy, no history of hypertension, diabetes and other diseases; 3. No history of chronic cough and expectoration , and normal lung function; 4. The patient had no respiratory infection within 4 weeks; 5. No antibiotics were used within 30 days prior to screening.
Exclusion criteria
Exclusion criteria: 1. Failure to complete the relevant inspection of this project,or unable to cooperate for other reasons; 2. The patient was associated with other respiratory diseases except for COPD, such as asthma, interstitial pneumonia, active tuberculosis, community-acquired pneumonia, lung cancer, bronchiectasis, pulmonary heart disease, pulmonary embolism, etc.; 3. Antibiotics were used within 30 days prior to screening; 4. The following situation may affect the informed effectiveness of participation in this study:alcoholism, narcotic drug abuse, history of drug abuse, history of mental illness, unfavored motive, paranoia, or other emotional or intellectual problems; 5. Participating in other drug clinical trials or stopping for less than 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of primary spirometry parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of acute exacerbation;mMRC score;CAT score; | — |
Countries
China
Contacts
Public ContactXiaowei
Qilu Hospital, Shandong University
Outcome results
None listed