China Chronic Obstructive Pulmonary Disease Registration Research

Transformation and Application of Diagnosis and Treatment Programs for COPD Based on Chronic Obstructive Pulmonary Disease Registration Research in China

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.

Study Overview

Status

Unknown

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.

Study Type

Observational

Enrollment (Anticipated)

3012

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Peoples are diagnosed with Chronic Obstructive Pulmonary Disease (COPD).

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Western medicine
Patients in this group only choose conventional medicine treatment based on the classes of medications recommended by 2015 GOLD for COPD.
Traditional Chinese Medicine
Patients in this group only choose conventional medicine treatment based on the Chinese Treatment Guidelines for COPD.
Integrative Medicine
Patients in this group choose western medicine and Traditional Chinese Medicine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The frequency of exacerbation
Time Frame: Change from Baseline in the frequency of exacerbation at the months 3, 6, 9, 12, 15, 18, 21 and 24.
Change from Baseline in the frequency of exacerbation at the months 3, 6, 9, 12, 15, 18, 21 and 24.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
all cause mortality
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Forced expiratory volume in one second,FEV1
Time Frame: Change from Baseline in the FEV1 at the months 6, 12, 18 and 24.
Change from Baseline in the FEV1 at the months 6, 12, 18 and 24.
Dyspnea
Time Frame: Change from Baseline in the mMRC at the months 3, 6, 9, 12, 15, 18, 21 and 24.
Using modified british medical research council (mMRC) to assess the degree of dyspnea in patients with COPD, and how this changes over time.
Change from Baseline in the mMRC at the months 3, 6, 9, 12, 15, 18, 21 and 24.
Symptoms
Time Frame: Change from Baseline in the CAT at the months 6, 12, 18 and 24.
Using the COPD Assessment Test (CAT) as a comprehensive measure of symptoms.
Change from Baseline in the CAT at the months 6, 12, 18 and 24.
Quality of life
Time Frame: Change from Baseline in the SF-36 at the months 6, 12, 18 and 24.
Using the Chinese version of the 36-item Short Form Health Survey (SF-36) to measure quality of life.
Change from Baseline in the SF-36 at the months 6, 12, 18 and 24.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

September 29, 2015

First Submitted That Met QC Criteria

October 7, 2016

First Posted (Estimate)

October 11, 2016

Study Record Updates

Last Update Posted (Actual)

February 6, 2018

Last Update Submitted That Met QC Criteria

February 4, 2018

Last Verified

February 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pulmonary Disease, Chronic Obstructive

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