chronic obstructive pulmonary disease
Conditions
Interventions
Subjects with COPD or "at risk" of COPD vs control subjects:Nil
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects with COPD or "at risk" of COPD: 1. Provision of informed consent prior to any study-specific procedure; 2. Resident of Guangzhou area; 3. Men and women aged 40–79 years; 4. Either: (1) A diagnosis of COPD at stage I to IV according to GOLD 2008 or being at risk for COPD (ie, GOLD stage 0) according to the following definition: (2) Chronic cough and sputum production for at least 3 months in each of two consecutive years without any other condition explaining the cough and a post-bronchodilator FEV 1 /FVC >= 0.7 and FEV 1 >= 80% PN. 5. Able to read and fluent in local language, in order that they are able to complete the study questionnaires. Control Subjects: 1. Provision of informed consent prior to any study-specific procedure; 2. Resident of Guangzhou area; 3. A post-bronchodilator value of FEV 1 /FVC >= 0.7 and FEV 1 >= 80% PN and without any respiratory disease or chronic respiratory symptoms; 4. Men and women aged 40–79 years, age and gender matched with the COPD or at risk of COPD study population; 5. Able to read and fluent in local language, in order that they are able to complete the study questionnaires.
Exclusion criteria
Exclusion criteria: Subjects with COPD or "at risk" of COPD: 1. Asthma (eg, as defined by GINA 2008) in the absence of COPD symptoms or diagnosis; 2. Significant disease or disorder, eg cardiovascular, pulmonary other than COPD, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results of the study, or the subjects ability to participate in the study; 3. Chronic respiratory failure including requirement for regular oxygen therapy; 4. A severe exacerbation of COPD (defined as use of antibiotics and/or oral/systemic glucocorticosteroids or hospitalisation related to COPD worsening) within 1 month prior to Visit 1; 5. Participation in another study involving drug administration or blood donation (more than 500 ml) within 3 months of Visit 1; 6. Planned hospitalisation during the course of the study; 7. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site); 8. Change of maintenance medication or start of new medication for COPD within 1 month prior to Visit 1. Control Subjects; 1. Significant disease or disorder, eg cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results of the study, or the subjects ability to participate in the study; 2. Any chronic respiratory symptom or chronic respiratory disease; 3. Participation in another study involving drug administration or blood donation (more than 500 ml) within 3 months of Visit 1; 4. Planned hospitalisation during the course of the study; 5. Involvement in the planning and conduct of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the frequency of exacerbations;The duration of exacerbations;The severity of exacerbations; | — |
Countries
China
Contacts
Public ContactNanshan Zhong/ Rongchang Chen
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed