Clinical trial NCT01836016: A Randomized Comparative Effectiveness Research Trial of Three Treatments for COPD Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Pulmonary Disease, Chronic Obstructive
Comparative effectiveness research
Medicine, Chinese Traditional
Humans
Treatment Outcome
Lead sponsor: Henan University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2013-04-19
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: COPD affects millions worldwide. The high prevalence, morbidity, mortality and economic burdens of COPD are increasing steadily. Although many therapies exist and are being developed to relieve symptoms and reduce mortality in COPD, most have only been studied in placebo-controlled efficacy studies in highly selected populations. There are few clinical trials to compare therapeutic alternatives in real world. Much of the comparative research evidence in COPD has been based on observational studies. Furthermore, studies in real world populations of COPD that received different therapies that do have efficacy evidence was found wide variations in care delivery. These considerations highlight the need to identify the most effective therapies in real world COPD patients and to design and test efforts to translate this evidence into healthcare for the millions of COPD patients. In short, there is a need for comparative effectiveness research (CER) in COPD.

CER has received growing attention worldwide. The direct comparisons of treatment alternatives provided by CER can help patients and providers make best informed treatment decisions where such evidence was previously lacking. Some randomized controlled trials on comprehensive Traditional Chinese medicine (TCM) interventions, especially based on the TCM patterns, have been the certain evidence for showing definite effect for stable COPD patients. When facing many treatment approaches, how to choose the most suitable treatment is difficult to identify. Hence, the aim of this study is to compare the effectiveness and economic evaluation of three treatments for COPD patients and then determine which treatment is the most suitable for COPD patients. conventional medicine, TCM treatment and Combination of both conventional medicine and TCM treatment.

This is a multi-center, pragmatic, randomized, controlled trial to evaluate the effectiveness of three treatments in COPD subjects. Following a 14 day run-in period, approximately 360 subjects will be randomly assigned to one of the three treatments (conventional medicine, Traditional Chinese medicine, and combination of both conventional medicine and TCM treatment) for 26 weeks. After the 26 weeks treatment period, subjects in three treatments arms will follow-up 26 weeks. The primary outcome measure is the frequency of exacerbations. and. Secondary efficacy measures include FEV1, Dyspnea (MMRC), Exercise Capacity( 6MWD), Quality of life (CAT) and economic evaluation(CEA, CUA). Safety will be assessed through the collection of adverse events. There will be a total of 5 study visits (baseline, the 13, 26 weeks of the treatment, 13 and 26 weeks of follow-up). A follow-up contact for collection of effect and economic evaluation will be conducted approximately 26 weeks following the last study visit.

Eligibility criteria: Inclusion Criteria:

* 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.

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 .
* 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.

Primary outcomes:
measure: the frequency of exacerbation
timeFrame: 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:
measure: Forced expiratory volume in one second
timeFrame: Change from Baseline in FEV1 at Week 26 of the treatment phase, Week 26 of the follow-up phase.
measure: Dyspnea
timeFrame: Change from Baseline in MMRC at Week 13 and 26 of the treatment phase, Week 13 and 26 of the follow-up phase.
measure: 6 Minutes Walking Distance Test(6MWD)
timeFrame: Change from Baseline in 6MWD at Week 13 and 26 of the treatment phase, Week 13 and 26 of the follow-up phase.
measure: Quality of life
timeFrame: Change from Baseline in CAT at Week 13 and 26 of the treatment phase, Week 13 and 26 of the follow-up phase.
measure: Economic Evaluation
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
state: Henan
Study officials:
affiliation: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
name: Jiansheng Li, MD
role: STUDY_CHAIR
References:
citation: 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.