Realize the Current Situation of COPD Patients in China

NCT ID: NCT03131362

Last Updated: 2022-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5020 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-30

Study Completion Date

2020-08-06

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Obstructive Pulmonary Disease COPD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Beijing, , China

Site Status

Countries

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China

References

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Yang T, Cai B, Cao B, Kang J, Wen F, Chen Y, Jian W, Wang C. REALizing and improving management of stable COPD in China: results of a multicentre, prospective, observational study (REAL). Ther Adv Respir Dis. 2023 Jan-Dec;17:17534666231178692. doi: 10.1177/17534666231178692.

Reference Type DERIVED
PMID: 37318116 (View on PubMed)

Yang T, Cai B, Cao B, Kang J, Wen F, Chen Y, Jian W, Wang C. Exacerbation in patients with stable COPD in China: analysis of a prospective, 52-week, nationwide, observational cohort study (REAL). Ther Adv Respir Dis. 2023 Jan-Dec;17:17534666231167353. doi: 10.1177/17534666231167353.

Reference Type DERIVED
PMID: 37073797 (View on PubMed)

Yang T, Cai B, Cao B, Kang J, Wen F, Chen Y, Jian W, Wang C. Treatment patterns in patients with stable COPD in China: analysis of a prospective, 52-week, nationwide, observational cohort study (REAL). Ther Adv Respir Dis. 2023 Jan-Dec;17:17534666231158283. doi: 10.1177/17534666231158283.

Reference Type DERIVED
PMID: 37013442 (View on PubMed)

Yang T, Cai B, Cao B, Kang J, Wen F, Chen Y, Jian W, Shang H, Wang C. Severity distribution and treatment of chronic obstructive pulmonary disease in China: baseline results of an observational study. Respir Res. 2022 Apr 29;23(1):106. doi: 10.1186/s12931-022-02021-w.

Reference Type DERIVED
PMID: 35488337 (View on PubMed)

Yang T, Cai B, Cao B, Kang J, Wen F, Yao W, Zheng J, Ling X, Shang H, Wang C. REALizing and improving management of stable COPD in China: a multi-center, prospective, observational study to realize the current situation of COPD patients in China (REAL) - rationale, study design, and protocol. BMC Pulm Med. 2020 Jan 13;20(1):11. doi: 10.1186/s12890-019-1000-x.

Reference Type DERIVED
PMID: 31931767 (View on PubMed)

Other Identifiers

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D2287R00114

Identifier Type: -

Identifier Source: org_study_id

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