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

Sponsor

Henan University of Traditional Chinese Medicine (Other)

Overall Status

Unknown status

CT.gov ID

NCT01486186

Collaborator

(none)

504

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Disease, Chronic Obstructive	Drug: Traditional Chinese Medicine Drug: placebo chinese medicine	Phase 2

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

504 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2011

Anticipated Primary Completion Date :

Dec 1, 2014

Anticipated Study Completion Date :

Dec 1, 2014

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: traditional chinese medicine

The experimental group will receive three type of TCM, they are Baofei granule, Bufeijianpi granule and Bufeiyishen granule.

Drug: Traditional Chinese Medicine

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.

Other Names:

Baofei granule

Bufeijianpi granule

Bufeiyishen granule

Placebo Comparator: placebo

placebo chinese medicine in addition to best care according to clinical guidelines for COPD patients

Drug: placebo chinese medicine

There are 3 placebo Recipe for the 3 traditional Chinese syndrome.

Other Names:

placebo Baofei granule

placebo Bufeijianpi granule

placebo Bufeiyishen granule

Outcome Measures

Primary Outcome Measures

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

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 [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]
using COPD Assessment Test ( CAT) and short-form 36-item questionnaire (SF-36)
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.