China Chronic Obstructive Pulmonary Disease Registration Research

NCT ID: NCT02929537

Last Updated: 2018-02-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 3012 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2019-12-31

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Western medicine

Patients in this group only choose conventional medicine treatment based on the classes of medications recommended by 2015 GOLD for COPD.

No interventions assigned to this group

Traditional Chinese Medicine

Patients in this group only choose conventional medicine treatment based on the Chinese Treatment Guidelines for COPD.

No interventions assigned to this group

Integrative Medicine

Patients in this group choose western medicine and Traditional Chinese Medicine.

No interventions assigned to this group

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).

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henan University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jiansheng Li, doctor

Role: STUDY_CHAIR

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Other Identifiers

COPD registration

Identifier Type: -

Identifier Source: org_study_id