Realize the Current Situation of COPD Patients in China (REAL)

AstraZeneca

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease COPD

Study type: Observational

Funder types: Industry

Identifiers

NCT03131362

D2287R00114

Details and patient eligibility

About

This is a multi-centre, prospective, observational study to realize the current situation of COPD patients in China. About 5000 COPD patients will be enrolled from 50 participating sites around China and followed up for one year. During this study, patients will undergo clinical assessments and receive medical care as determined by their treating physician.

Full description

This is a multi-centre, prospective, observational study. This study aims to observe the general situation in clinical practice, and the evolution and outcome of current usual care of COPD in China.This is an observational study. It will be carried out under routine clinical practice and the treatment will be determined by patients' treating physicians. Information about exposure to treatments as part of routine care will be collected (dose, frequency and duration).

A multi-stage, stratified and cluster sampling method will be used to select a nationally representative sample from the tertiary and secondary hospitals with respiratory department in six geographic regions around China as the study sites. Approximately 5000 patients with COPD will be enrolled from 50 selected study sites in order to recruit a nationally representative study population and followed up for one year.

Enrollment: 5,020 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Outpatients, more than 40 years old
• Clinically diagnosed as COPD (the patients are clinically diagnosed as COPD based on chronic cough, sputum, wheeze and a history of exposure to harmful factors, and confirmed by spirometry(FEV1/FVC<0.7, post-bronchodilator according to GOLD 2016)
• Sign (or their legally-acceptable representatives must sign) and date the informed consent form indicating that they understand the purpose of and procedure required for the study and are willing to participate in the study.

Exclusion criteria

• Participated in any interventional clinical trial during the last 30 days
• With acute exacerbation within 4 weeks before enrolment
• Not suitable for study observation judged by investigators.