chronic obstructive pulmonary disease
Conditions
Interventions
experimental group:Basic medical treatment: All enrolled subjects were treated with glycyrronium bromide formoterol aerosol (Bivorpin ? Ring-chong ?). 120 pups, each containing glycyrronium 7.2µg and
The diet is light, avoid drinking and spicy and irritating food
Pay attention to rest, keep healthy life, keep a good mood.
The experimental group was given "Gushen Pingchuan prescription" granules on the basis of basic drug treatment, one dose per day, washed in
control group:Basic medical treatment: All enrolled subjects were treated with glycyrronium bromide formoterol aerosol (Bivorpin ? Ring-chong ?). 120 pups, each containing glycyrronium 7.2µg and formo
Pay attention to rest, keep healthy life, keep a good mood.
The control group was given "placebo" granules on the basis of basic drug treatment, 1 dose per day, diluted into 200ml, and taken twice.
Sponsors
the First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
40 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) Those who meet the diagnostic criteria of COPD stable stage and lung-kidney qi deficiency syndrome. (2) Age 40 ~ 85 years old, male and female. (3) Patients in groups B and E for disease severity according to the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) (2024) and stable for 4 weeks or more. (4) If the patient is treated with a non-glontium formoterol inhalation aerosol (Bivopin ® Rechang ®), a 4-week washout period will be required to switch to Glontium formoterol inhalation aerosol (Bivopin ® Rechang ®). (5) The patient or his/her agent agrees to the treatment and signs the informed consent.
Exclusion criteria
Exclusion criteria: (1) known to be allergic to the ingredients contained in the investigational drug; (2) patients with previous thoracic surgery; (3) patients with severe respiratory diseases such as tuberculosis, pneumoconiosis, lung cancer, interstitial lung disease, bronchial asthma, bronchiectasis with hemoptysis and pulmonary fibrosis; (4) patients with serious primary diseases of cardiovascular, cerebrovascular, liver, kidney and hematopoietic system; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were greater than 1.5 times the upper limit of normal value, and serum creatinine (Cr) was greater than the upper limit of normal value (refer to the normal range of laboratory tests in our hospital). (5) alcoholism, drug dependence, epilepsy history or mental disorders; (6) pregnant, lactating women or planned pregnancy (including male and female); (7) those who have participated or are participating in other clinical trials within 3 months; (8) other patients deemed by the investigator to be unsuitable for the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pulmonary function test results;adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of acute exacerbations admitted during the trial period;TCM syndrome score evaluation;The six-minute walk test;COPD Assessment Test;St George's Respiratory Questionnaire;Blood routine: White blood cell count (WBC) red blood cell (RBC) Hemoglobin (HGB) Platelet (PLT);Liver function: alanine aminotransferase (ALT) Aspartate aminotransferase (AST) Total bilirubin (TBIL) Alkaline phosphatase (ALP) Glutamyltransferase (GGT);Renal function: Blood urea nitrogen (BUN) creatinine (Cr); | — |
Countries
China
Contacts
Public ContactWei Li
the First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed