A Randomized Comparative Effectiveness Research Trial of Three Treatments for COPD Patients
Comparison of Conventional Medicine, TCM Treatment and Combination of Both Conventional Medicine and TCM Treatment for Patients With Chronic Obstructive Pulmonary Disease: A Randomized Comparative Effectiveness Research Trial
1 other identifier
interventional
360
1 country
1
Brief Summary
The aim of this study is to compare the effectiveness and economic evaluation of three treatments for Chronic Obstructive Pulmonary Disease (COPD) patients: one, conventional medicine based on 2011 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines; another, TCM treatments, which have been evaluated and have certain effect; and finally, combination of both conventional medicine and TCM treatment, then determine which treatment is the most suitable for COPD patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2013
CompletedFirst Posted
Study publicly available on registry
April 19, 2013
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedApril 19, 2013
April 1, 2013
2 years
April 1, 2013
April 11, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the frequency of exacerbation
Change from Baseline in the frequency of exacerbation at Week 13 and 26 of the treatment phase, Week 13 and 26 of the follow-up phase.
Secondary Outcomes (5)
Forced expiratory volume in one second
Change from Baseline in FEV1 at Week 26 of the treatment phase, Week 26 of the follow-up phase.
Dyspnea
Change from Baseline in MMRC at Week 13 and 26 of the treatment phase, Week 13 and 26 of the follow-up phase.
6 Minutes Walking Distance Test(6MWD)
Change from Baseline in 6MWD at Week 13 and 26 of the treatment phase, Week 13 and 26 of the follow-up phase.
Quality of life
Change from Baseline in CAT at Week 13 and 26 of the treatment phase, Week 13 and 26 of the follow-up phase.
Economic Evaluation
52 weeks
Study Arms (3)
conventional medicine
EXPERIMENTALAccording to the individualized assessment of symptoms and exacerbation risk recommended by revised 2011 GOLD, patients in this group will be given conventional medicine treatment including three drugs, which are Salbutamol (Ventolin®), Formoterol (Oxis Turbuhaler®), Salmeterol / fluticasone (Seretide®).
traditional Chinese medicine
EXPERIMENTALPatients in this group will receive four types of TCM treatment according to traditional Chinese syndrome differentiation and treatment, which are Bufei granule, Bufeijianpi granule, Bufeiyishen granule and Yiqizishen granule.
conventional medicine + TCM
EXPERIMENTALPatients in this group will receive conventional medicine and traditional Chinese medicine.
Interventions
According to the revised 2011 GOLD, patients will be divided into Group A, B, C, and D based on individualized assessment. Salbutamol was used to Group A patients for 26 weeks: Salbutamol (Ventolin®, GlaxoSmithKline) 100μg/dose, 200 inhalations. 100 μg each time (when needed), and the maximum dose is 8-12 inhalations a day.
According to the revised 2011 GOLD, patients will be divided into Group A, B, C, and D based on individualized assessment. Formoterol was used to Group B patients for 26 weeks: Formoterol (Oxis Turbuhaler®, AstraZeneca), 4.5μg/ dose, 60 inhalations. 4.5μg each time, twice daily.
According to the revised 2011 GOLD, patients will be divided into Group A, B, C, and D based on individualized assessment. Salmeterol / fluticasone was used to Group C patients and Group D patients for 26 weeks: Salmeterol / fluticasone (Seretide®, GlaxoSmithKline), 50/500 μg / dose, 60 inhalations. 50/500 μg each time, twice daily.
According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of lung-qi deficiency will be given Bufei granule, twice daily for 26 weeks for lower dosage.
According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of deficiency of pulmonic-splenic qi will be given Bufeijianpi granule, twice daily for 26 weeks for lower dosage.
According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of insufficiency of qi of the lung and kidney will be given Bufeiyishen granule, twice daily for 26 weeks for lower dosage.
According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of insufficiency of qi and yin of the lung and kidney will be given Yiqizishen granule, twice daily for 26 weeks for lower dosage.
Patients will be given the combination of conventional medicine (Salbutamol, Formoterol, Salmeterol / fluticasone, Salmeterol / fluticasone) and (Bufei granule, Bufeijianpi granule, Bufeiyishen granule and Yiqizishen granule) for 26 weeks.
Eligibility Criteria
You may qualify if:
- A confirmed diagnosis of mild to very severe COPD.
- medically stable
- Age between 18 and 80 years.
- Syndrome differentiation belongs to Syndrome of lung-qi deficiency, Syndrome of deficiency of pulmonic-splenic qi, Syndrome of insufficiency of qi of the lung and kidney, syndrome of insufficiency of qi and yin of the lung and kidney.
- Without participations in other interventional trials in the previous one month.
- With the informed consent signed.
You may not qualify if:
- Pregnant or breast-feeding women.
- Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study .
- Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within the last 5 years.
- Current respiratory disorders other than COPD (e.g., bronchiectasis, tuberculosis, lung fibrosis, pulmonary thromboembolic).
- Complicated with heart failure (NYHA Class III or IV),or myocardial infarction within six months ,or unstable hemodynamics.
- Complicated with serious hepatic and renal diseases (liver cirrhosis, portal hypertension, bleeding of varicose veins, dialysis, or renal transplantation).
- Participating in other trials or allergic to the used medicine.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou, Henan, 450000, China
Related Publications (1)
Li JS, Xie Y, Li SY, Yu XQ. Comparison of conventional medicine, TCM treatment, and combination of both conventional medicine and TCM treatment for patients with chronic obstructive pulmonary disease: study protocol of a randomized comparative effectiveness research trial. Trials. 2014 May 1;15:153. doi: 10.1186/1745-6215-15-153.
PMID: 24885672DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jiansheng Li, MD
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2013
First Posted
April 19, 2013
Study Start
May 1, 2013
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
April 19, 2013
Record last verified: 2013-04