Clinical trial NCT02929537: China Chronic Obstructive Pulmonary Disease Registration Research
Official title: Transformation and Application of Diagnosis and Treatment Programs for COPD Based on Chronic Obstructive Pulmonary Disease Registration Research in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Pulmonary Disease, Chronic Obstructive
registration research
Medicine, Chinese Traditional
Lead sponsor: Henan University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2016-10-11
Enrollment: 3012
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Peoples are diagnosed with Chronic Obstructive Pulmonary Disease (COPD).

Brief summary: With the comparative effectiveness research methods and hospital registration study approach, the purpose of this study is to objectively record the methods, efficacy and its influencing factors of COPD commonly used treatment methods/programs (Western medicine, Traditional Chinese Medicine and Integrative Medicine) in the actual medical environment, analysis of application characteristics for the different programs, and provide the basis for its revision and promotion. It is a first registration study for COPD in China.

Detailed description: Chronic obstructive pulmonary disease (COPD) is a major disease of harm public health seriously. Although different treatment methods / programs (Western medicine, Traditional Chinese Medicine and Integrative Medicine) exist and are being developed to relieve symptoms and reduce mortality in COPD, most have only been studied in randomized controlled trials (RCT).

Most RCT study patients usually require a single disease, the use of standard treatment and a single intervention to evaluate interventions in an ideal state can achieve maximum effect,that is theoretical effect, it is difficult to provide the evidence of practical clinical efficacy or effectiveness. Secondly, RCT often require strict inclusion and exclusion criteria, resulting in inadequate representation of the study, thus limiting its conclusions spread to overall. There are some challenges for different treatment methods on the actual effect of the patients in the evaluation of conventional medical practice with RCT.

Real World Research based on clinical practice pay close attention highly in response to these problems, and the registry study had been applied widely in clinical practice. With the comparative effectiveness research methods and hospital registration study approach, based on the classes of medications recommended by 2014 GOLD and Chinese Treatment Guidelines for COPD, the purpose of this study is to objectively record the methods, efficacy and its influencing factors of COPD commonly used treatment methods/programs (Western medicine, Traditional Chinese Medicine and Integrative Medicine) in the actual medical environment, analysis of application characteristics for the different programs, and provide the basis for its revision and promotion. This is a first registration study for COPD in China.

Eligibility criteria: Inclusion Criteria:

* A confirmed diagnosis of COPD.
* 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.
* Complicated with respiratory disorders other than COPD (e.g., lung fibrosis, pulmonary thromboembolic).
* Complicated with heart failure (NYHA Class III or IV),or myocardial infarction within six months.
* Complicated with serious hepatic and renal diseases (liver cirrhosis, portal hypertension, bleeding of varicose veins, dialysis, or renal transplantation).

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.
Secondary outcomes:
measure: all cause mortality
timeFrame: through study completion, an average of 1 year
measure: Forced expiratory volume in one second,FEV1
timeFrame: Change from Baseline in the FEV1 at the months 6, 12, 18 and 24.
measure: Dyspnea
timeFrame: Change from Baseline in the mMRC at the months 3, 6, 9, 12, 15, 18, 21 and 24.
measure: Symptoms
timeFrame: Change from Baseline in the CAT at the months 6, 12, 18 and 24.
measure: Quality of life
timeFrame: Change from Baseline in the SF-36 at the months 6, 12, 18 and 24.
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: