China Chronic Obstructive Pulmonary Disease Registration Research

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02929537
• Other study ID #: COPD registration
• Status: Enrolling by invitation
• Phase: N/A
• First received: September 29, 2015
• Last updated: February 4, 2018
• Start date: May 2015
• Est. completion date: December 2019

Study information

• Verified date: February 2018
• Source: Henan University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 3012
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Henan University of Traditional Chinese Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The frequency of exacerbation		Change from Baseline in the frequency of exacerbation at the months 3, 6, 9, 12, 15, 18, 21 and 24.
Secondary	all cause mortality		through study completion, an average of 1 year
Secondary	Forced expiratory volume in one second,FEV1		Change from Baseline in the FEV1 at the months 6, 12, 18 and 24.
Secondary	Dyspnea	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.
Secondary	Symptoms	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.
Secondary	Quality of life	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.