Table 3 Details of follow-up visits
Follow-up Visit | Baseline(V1) | Before randomize(V2) | The first time after randomization(V3) | The second time after randomization(V4) | The third time after randomization(V5) | The fourth time after randomization(V6) |
|---|---|---|---|---|---|---|
Screening period | 4 weeks ± 1 day after washout period (in demand) | 6 months ± 3 days after randomization | 12 months ± 3 days after randomization | 18 months ± 3 days after randomization | 24 months ± 3 days after randomization | |
Informed consent | x | |||||
Basic information | x | |||||
Alteration of basic information | x | x | x | x | x | |
History of COPD | x | |||||
Criteria | x | |||||
Wash-out | x | |||||
SGRQ | x | x | x | x | x | x |
CAT | x | x | x | x | x | x |
mMRC | x | x | x | x | x | x |
BODE | x | x | x | x | x | x |
AECOPD questionnaire | x | x | x | x | x | x |
Physical examination | x | x | x | x | x | x |
Lung function test | x | x | x | x | x | x |
6 min walk time, 6MWT | x | x | x | x | x | x |
Arterial blood gas analysis | x | x | ||||
Other medication | x | x | x | x | x | x |
Adverse events report | x | x | x | x | x |