Chronic obstructive pulmonary disease
Conditions
Interventions
Experimental group:Budesonide formoterol powder inhaler (160 µ g / 4.5 µ g, once in the morning and evening, 2 inhalation each time) + Bushen Yiqi recipe (modified), one bag at a time, once in the mor
control:Budesonide formoterol powder inhaler (160 µ g / 4.5 µ g, once in the morning and evening, 2 inhalation each time) + Bushen Yiqi recipe (modified) simulator, one bag at a time, once in the morn
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
40 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) FEV1/FVC < 0.7, 30% <= FEV1 < 80% predicted after bronchodilator and patients were clinically diagnosed as chronic obstructive pulmonary disease. (2) iIn the stable phase, there was no respiratory tract infection and acute attack of chronic obstructive pulmonary disease in recent 4 weeks; (3) the syndrome differentiation of traditional chinese medicine is the syndrome of deficiency of both lung and kidney; (4) patients with COPD with high risk of acute exacerbation (at least 2 acute exacerbations or at least one hospitalization due to acute exacerbation in the past year); (5) 40 years old <= 85 years old, regardless of sex; (6) the subjects had informed consent and had signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) airway obstruction caused by asthma and other non-chronic obstructive pulmonary disease; (2) those who had received lung transplantation or pneumonectomy; (3) those who needed long-term oxygen therapy (daily oxygen inhalation time >= 12 hours); (4) previous history of chronic alcoholism or drug abuse; (5) at present, it is standardized to use oral glucocorticoid; (6) those who are currently undergoing pulmonary rehabilitation treatment; (7) accompanied by serious diseases of heart, liver and kidney; (8) patients with malignant tumor, leukemia, aplastic anemia, myelodysplastic syndrome, thrombocytopenia, multiple myeloma and other hematological diseases; (9) those who are allergic or intolerant to the study of drugs; (10) to participate in other clinical researchers in the previous 4 weeks; (11) Women who are pregnant or planning to become pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dyspnea classification;Quality of life;BODE score;Frequency and degree of acute exacerbation of COPD; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quantitative score of TCM syndrome;Blood gas analysis;inflammation and immune related Indexes and function of HPA Axis;Safety index;Pulmonary function (FEV1%, FEV1/FVC%);Exercise tolerance 6-minute walking test; | — |
Countries
China
Contacts
Public ContactDong Jingcheng
Huashan Hospital, Fudan University
Outcome results
None listed