Clinical trial NCT03007914: Effect of Traditional Chinese Medicine on Outcomes in COPD Patients
Official title: A Multi-center, Prospective, Cohort Study to Evaluate the Effectiveness of Traditional Chinese Medicine on COPD Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Pulmonary Disease, Chronic Obstructive
Medicine, Chinese Traditional
Humans
Treatment Outcome
Lead sponsor: Henan University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2017-01-02
Enrollment: 2540
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: COPD patients

Brief summary: The aim of this study is to compare the effectiveness of the treatments in two cohort for COPD patients: one, traditional Chinese medicine (TCM) cohort, which have been evaluated and have certain effect; the other, conventional medicine treatments cohort, based on 2015 Global Initiative for Chronic Obstructive Lung Disease (GOLD).

Detailed description: COPD, with high prevalence, morbidity, mortality and economic burdens, affects millions worldwide. 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. Furthermore, some randomized controlled trials on comprehensive TCM interventions, especially based on the TCM patterns, have been the certain evidence for showing definite effect for COPD patients. In addition, studies in real world populations of COPD that received different therapies that do have efficacy evidence was found wide variations in care delivery. In short, there is a need for cohort study in COPD.

This is a multi-center, prospective, cohort study to evaluate the effectiveness of TCM on COPD patients. The cohort study will enroll approximately 2540 patients that in two cohort, one, TCM cohort, which have been evaluated and have certain effect; the other, conventional medicine treatments cohort, based on 2015 Global Initiative for Chronic Obstructive Lung Disease (GOLD).Subjects in two cohort will be followed-up 2 years.The primary outcome measure is the frequency of exacerbations. The secondary efficacy measures include mortality rate and all-cause mortality, FEV1, dyspnea (MMRC), exercise capacity( 6MWD), quality of life ( CAT, SF-36 and COPD-PRO), and effectiveness satisfaction with treatment(ESQ-COPD).

Eligibility criteria: Inclusion Criteria:

* A confirmed diagnosis of COPD.
* Medically stable.
* Age between 40 and 80 years.
* Syndrome differentiation belongs to syndrome of deficiency of deficiency of lung qi, 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.
* With the informed consent signed.
* Capable of complying with the dosing regimen and visit schedules.

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, bronchial asthma, tuberculosis, lung fibrosis, pulmonary thromboembolic, diffuse panbronchiolitis).
* 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).
* Complicated with congenital or acquired immune deficiency.
* 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 the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.
Secondary outcomes:
measure: All cause mortality
timeFrame: The all-cause mortality in 2 years of the follow up phase.
measure: Forced expiratory volume in one second
timeFrame: Change from Baseline in the one second (FEV1) at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.
measure: Dyspnea
timeFrame: Change from Baseline in MMRC at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.
measure: Minutes Walking Distance Test (6MWD)
timeFrame: Change from Baseline in the 6MWD at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.
measure: COPD Assessment Test (CAT)
timeFrame: Change from Baseline in the CAT at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.
measure: Effectiveness satisfaction with treatment
timeFrame: Change from Baseline in the ESQ-COPD at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.
measure: Short Form 36-Item Health Survey (SF-36)
timeFrame: Change from Baseline in the SF-36 at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.
measure: Patient reported outcome for COPD (COPD-PRO)
timeFrame: Change from Baseline in the COPD-PRO at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.
Other outcomes:
Locations:
Study officials:
affiliation: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
name: Jiansheng Li, Doctor
role: STUDY_CHAIR
References: