China Chronic Obstructive Pulmonary Disease Registration Research

NCT02929537 | Unknown DMC

• 1 other identifier: COPD registration
• Study Type: observational
• Target: 3,012
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Pulmonary Disease, Chronic Obstructive; registration research; Medicine, Chinese Traditional

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• all cause mortality

  through study completion, an average of 1 year

• Forced expiratory volume in one second,FEV1

  Change from Baseline in the FEV1 at the months 6, 12, 18 and 24.

• Dyspnea

  Change from Baseline in the mMRC at the months 3, 6, 9, 12, 15, 18, 21 and 24.

• Symptoms

  Change from Baseline in the CAT at the months 6, 12, 18 and 24.

• Quality of life

  Change from Baseline in the SF-36 at the months 6, 12, 18 and 24.

Study Arms (3)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• A confirmed diagnosis of COPD.
• With the informed consent signed.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Henan University of Traditional Chinese Medicine: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jiansheng Li, doctor

  The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: October 11, 2016
• Study Start: May 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: February 6, 2018

Record last verified: 2018-02