Effect of Traditional Chinese Medicine on Outcomes in Patients With Mild/Moderate Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Detection and Intervention on Mild/Moderate Chronic Obstructive Pulmonary Disease by Traditional Chinese Medicine Treatment and Application

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Drug: Traditional Chinese Medicine
* Drug: placebo chinese medicine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A confirmed diagnosis of mild/moderate COPD. Age between 40 and 80 years. Syndrome differentiation belongs to Syndrome of lung-qi deficiency, Syndrome of deficiency of pulmonosplenic qi, Syndrome of insufficiency of QI of the lung and kidney. Without participation in other interventional trials in the previous one month. With the informed consent signed. Exclusion Criteria: Pregnant or breast-feeding women. Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study . Complicated with severe heart failure (class Ⅳ NYHA heart function) or unstable hemodynamics. Complicated with bronchial asthma, bronchiectasis or active tuberculosis； Complicated with obliterative bronchiolitis or diffuse pantothenic bronchiolitis， Complicated with pneumothorax, pleural effusion or pulmonary embolism. Complicated with neuromuscular disorder which affects the respiration. Complicated with tumors. Complicated with serious hepatic and renal diseases. Long periods of bed rest. Use of oral or parenteral corticosteroids before 1 months of Visit 1 . With immunodeficiency. Participating in other trials or allergic to the used medicine.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: traditional chinese medicine<br>The experimental group will receive three type of TCM, they are Baofei granule, Bufeijianpi granule and Bufeiyishen granule. | Drug: Traditional Chinese Medicine<br>* 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.<br>* Other names: Bufeiyishen granule;|
| Placebo Comparator: placebo<br>placebo chinese medicine in addition to best care according to clinical guidelines for COPD patients | Drug: placebo chinese medicine<br>* There are 3 placebo Recipe for the 3 traditional Chinese syndrome.<br>* Other names: placebo Bufeiyishen granule;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pulmonary function（FEV1） |  | 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 |  | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspnea |  | 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) | 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) |  | Change from Baseline in 6MWD at Week 13, 26, 39 and 52 of the treatment phase, Week 26 and 52 of the followup phase | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary Disease, Chronic Obstructive, Double-Blind Method, Medicine, Chinese Traditional, Humans, Treatment Outcome