Chronic obstructive pulmonary disease(COPD)
Conditions
Interventions
Experimental group:Symbicort? 160/4.5ug/breathing, 2 breathing/time, 2 times/day+Symbicort?160/4.5ug/breathing, prn
Control group 1:Symbicort 160/4.5ug/breathing, 2 breathing/time, 2 times/day + Turbuhaler 100ug/breathing, prn
Control group 2:Si Lihua 18ug/breathing, 1 breathing/time, 1 time/day + Auccitub 12ug/breathing, 2 times/day, and Turbuhaler 100ug/breathing, prn
Sponsors
The First Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: For inclusion in the study run-in period, patients must fulfil all of the following criteria at Visit 1: 1. Provision of informed consent. The signed and dated informed consent must have been obtained before conducting any study-related procedures; 2. Outpatients with a diagnosis of COPD; 3. Either sex, >=40 years of age; 4. History of using inhaled short acting bronchodilator (beta 2-agonist or anticholinergic drugs) as rapid relievers; 5. A history of smoking >=10 pack-years (one pack-year = one pack (20 cigarettes) per day for one year or equivalent); 6. At least one episode of AE-COPD (defined as oral/intravenous use of steroids and/or antibiotics, and/or receiving emergency treatment/hospitalization due to respiratory symptoms); 7. Post-bronchodilatory FEV1<=50% of normal predicted value; 8. Post-bronchodilatory FEV1/FVC<70% of normal predicted value.
Exclusion criteria
Exclusion criteria: Any of the following is regarded as a criterion for exclusion from the study: 1. A history of asthma; 2. Patients with seasonal allergic rhinitis, first onset before 40 years of age; 3. Presence of severe of unstable ischemic heart disease, cardiac arrhythmias, myocardiopathy, heart failure, poorly-controlled hypertension, or other cardiovascular diseases; 4. Other severe repiratory disease other than COPD; 5. Any other significant disease or disorder (eg, gastrointestinal, hepatic, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the investigator, either put the patient at risk because of participating in the study or may influence the results of the study, or the patient's ability to participate in the study; 6. Any clinically significant abnormal finding in biochemical indicators, blood routine, urine routine, ECG, physical examination or vital signs at Visit 1, judged as a possible risk to test subjects by the investigator. The above indicators must be checked at Visit 2; 7. Use of any ß-blocking agent, including eye-drops; 8. Pregnancy, breast-feeding, or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator; 9. Known or suspected hypersensitivity to study medications or adjuvant; 10. Planned in-patient hospitalisation during the course of the study; 11. Participating in another clinical study during the course of this study or within 8 weeks prior to Visit 1; 12. Suspected poor capability, as judged by the investigator, to follow instructions of the study, eg, because of a history of alcohol or drug abuse; 13. Planned or present enrollment in an intensified rehabilitation project of COPD; 14. AE-COPD 4 weeks before Visit 1 and/or during run-in period, defined as oral/intravenous use of steroids and/or antibiotics, and/or receiving emergency treatment/hospitalization due to respiratory symptoms; 15. In reversibility test, post-bronchodilatory FEV1>=80%; 16. Planned blood donation during the course of study; 17. Previous enrollment or allocation of randomisation code in the study; 18. Use of prohibited drugs (see Section 3.7, before study, concomitant medication, post-study treatment).
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| FVC;IC and IC/TLC;PEF;Scores of COPD symptom;Asumption of remission drugs;Health relative quality of life;Frequency of acute aggravation of COPD (AE-COPD);FEV1; | — |
Countries
China
Contacts
Public ContactYubiao Guo
Outcome results
None listed