A clinical trial to evaluate the efficacy and safety of Shufeng Jiedu capsule in acute exacerbation of chronic obstructive pulmonary disease (COPD)

INTERVENTION: Shufeng Jiedu capsule (4 capsules tid for 7 days) plus usual care will be used in the experimental group. Placebo (4 capsules tid for 7 days) plus usual care will be used in the control group. Usual care may include glucocorticoids, bronchodilators, oxygen therapy, and antibiotics. The study consists of the baseline visit, 7 days treatment period, followed by the EOT (End‐of‐Therapy, day 8)), and LFU (Late Follow‐up: 14 days after meeting discharge criteria,28 days after meeting discharge criteria, and 56 days after meeting discharge criteria) visits. Randomisation: A stratified, blocked random sequence is generated by R software. Drug containers prepared by an independent pharmacy were sequentially numbered and opened sequentially. Containers were of identical appearance, tamper‐proof and equal in weight. CONDITION: Chronic obstructive pulmonary disease ; Respiratory ; Chronic obstructive pulmonary disease PRIMARY OUTCOME: Severity of clinical symptoms is measured using EXACT‐PRO score at end of treatment at day 8. SECONDARY OUTCOME: ; 1. Clinical symptoms measured using CAT scores at end of treatment; EXACT‐PRO scores and CAT scores at day of meeting discharge criteria and three follow‐up time points (day of meeting discharge criteria + 14 days, day of meeting discharge criteria + 28 days, day of meeting discharge criteria + 56 days); EXACT‐PRO frequency and duration of symptom‐defined events, and severity of symptoms.; 2. QoL measured using SGRQ and EQ‐5D at end of treatment; EQ‐5D scores at day of meeting discharge criteria, day of meeting discharge criteria + 14 days, day of meeting discharge criteria + 28 days, day of meeting discharge criteria + 56 days.; 3. Length of stay (LOS) measured using the duration from admission to meeting discharge criteria.; 4. A total dose of antibiotics measured using DDDs.; 5. The frequency of recurrence of acute exacerbations of COPD during follow‐up 8 weeks (including medical consultation or admission).; 6. Hematologic biomarkers (full blood count, inflammation factors) absolute value and change from baseline at end of treatment.; 7. Death during hospitalization or follow‐up measured using patient records; 8. Safety measured using adverse event (AE) and adverse drug reaction (ADR) measured using patient records throughout the study period; INCLUSION CRITERIA: 1. Diagnosis of COPD or has been diagnosed in clinical record. 2. Has a current acute exacerbation of COPD with at least one of the following: a. Increased sputum purulence; b. Increased sputum volume; c. Increased breathlessness. 3. The patient with moderate or severe hospitalized acute exacerbation of COPD (FEV1%: 30% to 80%). 4. Males and females 40 or more years of age. 5. Patient must provide written informed consent prior to any study‐specific procedures, and willingness and ability to comply with all study procedures.