Chronic Obstructive Pulmonary Disease
Conditions
Interventions
Test group:Basic treatment of Western medicine+RunfeiGao
control group:Basic treatment of Western medicine+RunfeiGao simulant
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
30 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Pateints have been diagnosed with chronic obstructive pulmonary disease and are in the stable stage; (2) Patients have been diagnosed with TCM syndroms of "Lung Qi Deficiency"; (3) Patients belong to the E group according to the GOLD ABE evluation (=2 moderate acute exacerbations or 1 acute exacerbation leading to hospitalization in the past 1 year); (4) Patients with at least continuous use of dual inhaled drug combination (ICS+LABA or LABA+LAMA) or triple combination (open or close) for 3 months; (5) Patients aged 30-75 years old and with no gender limit; (6) Patients agreed to participate in this study and signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients accompanied by asthma active tuberculosis lung cancer bronchiectasis pulmonary embolism Interstitial lung disease or other active lung diseases; (2) Patient with acute exacerbations of chronic obstructive pulmonary disease or infections within 4 weeks before the enrollement; (3) Patients depend on long-term oxygen therapy (=12h per day) or ventilator-assisted breathing; (4) Patients with previous pulmonary resection or lung volume reduction surgery in the past 12 months; (5) Patients suffering from severe hypertension heart failure arrhythmia diabetes tumors or poor control of primary heart liver kidney and hematological diseases; (6) Patients with the Scr exceeding 1.5 times the upper limit of the reference value or AST/ALT 2 times the upper limit of the reference value; (7) Patients with a known or suspected history of alcohol or drug abuse; (8) Patients who are pregnant or breastfeeding or plan to become pregnant during the study period; (9) Patients who are allergic to the components of the research drug or who are not suitable for use as described in the instructions; (10) Patients who have participated in other clinical trials within the past 3 months; (11) People who are determined as not suitable to participate in this clinical trial by researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of moderate to severe AECOPD episodes per year; | — |
Secondary
| Measure | Time frame |
|---|---|
| superoxide dismutase( SOD);TGF-ß1;Breathlessness Cough and Sputum Scale;Time (days) to first moderate or severe AECOPD exacerbation during the treatment period;pentosidine;reactive oxygen species ( ROS);(St George's Respiratory Questionnaire;malonaldehyde ( MDA);IL-8;Time to first clinically important deterioration (CID) (days);IL-6;(Modified Medical Research Council;COPD Assessment Test;glutathione(GSH);soluble advanced glycation end product-specific receptor (sRAGE);N e -(carboxymethyl) lysine (ML);Pulmonary function indicators (FEV1 FVC FEV1/FVC);IL-1ß;TCM syndrome score;N e -(carboxyethyl) lysine (CEL);Severity of the first AECOPD;TNF-a; | — |
Countries
China
Contacts
Public ContactBing Mao
West China Hospital Of Sichuan University
Outcome results
None listed