Stable chronic obstructive pulmonary disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Consistent with the Western medicine diagnosis of chronic obstructive pulmonary disease, and in the clinical stable stage of chronic obstructive pulmonary disease; (2) accompanied by wheezing, fatigue and waist and knee pain symptoms; (3) The severity of airflow restriction in chronic obstructive pulmonary disease was GOLD grade 2 to 4; (4) The GOLD ABE assessment was in group E (=2 moderate acute exacerbations or 1 acute exacerbation leading to hospital admission within the past 1 year); (5) Age 40-75 (inclusive) years old, gender is not limited; (6) Agree to participate in the study and sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients with asthma, active tuberculosis, lung cancer, bronchiectasis, pulmonary embolism, pulmonary heart disease, pulmonary interstitial disease, bronchiolitis obliterans, diffuse panbronchiolitis or other active pulmonary diseases; (2) There were patients with AECOPD or infection within 4 weeks prior to enrollment; (3) Patients who need long-term oxygen therapy (daily oxygen inhalation time =12h) or are receiving pulmonary rehabilitation treatment; (4) Patients who had previously undergone pulmonary resection or underwent lung volume reduction surgery within 12 months before screening; (5) Patients with serious primary diseases of the heart, brain, liver, kidney and blood system, such as malignant tumors, heart failure, severe arrhythmia, and poorly controlled diabetes; (6) Patients with abnormal renal function Scr exceeding 1.5 times the upper limit of the reference value, or abnormal hepatic function AST and ALT exceeding 2 times the upper limit of the reference value; (7) Known or suspected history of alcohol or drug abuse; (8) Pregnant or lactating women or those planning to become pregnant during the study period; (9) Allergic to the ingredients of the study drug; (10) Participants in other clinical trials within the last 3 months; (11) Participants determined by the investigator to be unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of AECOPD episodes;Main symptoms of chronic obstructive pulmonary disease/TCM syndrome score; | — |
Secondary
| Measure | Time frame |
|---|---|
| First onset of AECOPD during the trial period (days);BCSS score;CAT score;mMRC score;Lung function indicators (FEV1, FVC, FEV1/FVC);The occurrence of clinically important indicators of deterioration (CID); | — |
Countries
China
Contacts
West China Hospital of Sichuan University