- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02929537
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
Study Overview
Status
Conditions
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
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- COPD registration
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.
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