The purpose of this study is evaluate the effects and safety of Traditional Chinese medicine for prevention and management of mild/moderate chronic obstructive pulmonary disease (COPD).
This is a multicenter, randomized, double-blind, placebo controlled study to evaluate the effect of Traditional Chinese medicine (TCM) in COPD subjects. Following a 14 day run-in period, approximately 504 subjects will be randomly assigned to double-blind treatment for 52 weeks. After the 52 weeks treatment period, subjects in both treatment arms will follow-up 52 weeks. The primary measure of efficacy is the frequency of exacerbations and spirometric values (e.g. FEV1). Secondary efficacy measures include Dyspnea (MMRC), Quality of life ( CAT,SF-36), Exercise Capacity( 6MWD). Safety will be assessed through the collection of adverse events. There will be a total of 5 study visits ( randomization, and after 13, 26, 39 and 52 weeks of treatment). A follow-up contact for collection of effect and adverse event will be conducted approximately 52 weeks following the last study visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
504
A herbal extract twice daily for 52 weeks for lower dosage, There are 3 Recipe for the 3 traditional Chinese syndrome, they are syndrome of lung-qi deficiency, syndrome of deficiency of pulmonosplenic qi, syndrome of insufficiency of QI of the lung and kidney.
There are 3 placebo Recipe for the 3 traditional Chinese syndrome.
pulmonary function（FEV1）
Time frame: Change from Baseline in FEV1 at Week 26 and 52 of the treatment phase, Week 26 and 52 of the followup phase
the frequency of exacerbation
Time frame: Change from Baseline in the frequency of exacerbation at Week 26 and 52 of the treatment phase, Week 26 and 52 of the followup phase
Dyspnea
Time frame: Change from Baseline in MMRC at Week 13, 26, 39 and 52 of the treatment phase, Week 26 and 52 of the followup phase
Quality of life
using COPD Assessment Test ( CAT) and short-form 36-item questionnaire (SF-36)
Time frame: Change from Baseline in CAT and SF-36 at Week 13, 26, 39 and 52 of the treatment phase, Week 26 and 52 of the followup phase
6 Minutes Walking Distance Test ( 6MWD)
Time frame: Change from Baseline in 6MWD at Week 13, 26, 39 and 52 of the treatment phase, Week 26 and 52 of the followup phase
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.