| |
Enrollment
|
Allocation
|
Post-allocation
|
|---|
|
Timepoint
|
− 7 days
|
0 ± 3 days
|
60 ± 3 days
|
120 ± 3 days
|
180 ± 3 days
|
240 ± 3 days
|
300 ± 3 days
|
360 ± 3 days
|
|
Enrolment:
| | | | | | | | |
|
Eligibility screen
|
X
| | | | | | | |
|
Informed consent
|
X
| | | | | | | |
|
Background information
|
X
| | | | | | | |
|
Interventions
| | | | | | | | |
|
MBYF or placebo
| | | | | | | | |
|
Budesonid and Formoteraol
| | | | | | | | |
|
Safety outcomes
| | | | | | | | |
|
ECG
| |
X
| | |
X
| | |
X
|
|
Chest X-ray or CT
| |
X
| | |
X
| | |
X
|
|
Laboratory examinations*
| |
X
| | |
X
| | |
X
|
|
AEs
| |
X
| | |
X
| | |
X
|
|
Primary outcomes
| | | | | | | | |
|
The frequency、time and severity of AECOPD
| |
X
|
X
|
X
|
X
|
X
|
X
|
X
|
|
CAT score
| |
X
| | |
X
| | |
X
|
|
Pulmonary function test
| |
X
| | | | | |
X
|
|
Secondary outcomes
| | | | | | | | |
|
mMRC dyspnea scale
| |
X
| | |
X
| | |
X
|
|
6MWT
| |
X
| | |
X
| | |
X
|
|
BODE index
| |
X
| | |
X
| | |
X
|
|
Quantitative score of TCM syndrome
| |
X
| | |
X
| | |
X
|
|
Inflammation indexes and HPA axis function
| |
X
| | | | | |
X
|
|
Other test
| | | | | | | | |
|
Genotypes
| |
X
| | | | | |
X
|
- MBYF modified Bushen Yiqi formulas, AECOPD acute exacerbation of COPD, CT computed tomography, AE adverse event, ECG electrocardiogram, CAT COPD assessment test, mMRC Modified Medical Research Council, 6MWT Six minutes of walking test, BODE B: body mass index (BMI), D: Degree of airflow obstruction, E: Evaluation of dyspnea, D: Dynamic ability, TCM traditional Chinese medicine, HPA hypothalamic-pituitary-adrenaline axis
- Laboratory examinations*: blood and urine routine, liver and kidney function, glucose
