Table 1 Study schedule of specific assessments

 Visit time

Day -28 to 0

day 0

week 4

Week 12

Week 24

Week 36

Week 52

–

Basic condition

  Signing informed consent

●

  Demographic information ^d

●

 General clinical information ^e

●

Efficacy assessments

 SGRQ scale

●

●

●

●

●

●

●

 CAT scale

●

●

●

●

●

●

●

 Symptom scale

●

●

●

●

●

●

●

●

 Number of exacerbations and duration

●

●

●

●

●

●

 Number of hospitalizations and reasons

●

●

●

●

●

●

 Constitution of TCM^f

●

●

●

Safety assessments

 Vital sign

●

●

●

●

●

●

●

●

 Physical examination

●

●

●

●

●

●

●

 HCG

●

 Glycosylated Hemoglobin

●

 Lung function

●

 Blood routine

●

●

●

 NGHX

●

●

●

 Serum biochemicals

●

●

●

 Adverse events recorded

●

●

●

●

●

●

●

Exploratory assessments ^g

 Microecology of the respiratory tract

●

●

●

●

●

●

●

 Herpesvirus infection

●

●

●

●

●

●

●

 Classification and counting of lymphocytes

●

●

●

●

●

●

●

 Inflammatory cytokines

●

●

●

●

●

●

●

 Immunoglobulin

●

●

●

●

●

●

●

Others

 Starting time of treatment

●

 Combination therapy

●

●

●

●

●

●

●

 Issue medications and diary cards

●

●

●

●

●

 Recycle medications and diary cards

●

●

●

●

●

 eCRF

●

●

●

●

●

●

●

●