Clinical trial NCT03131362: Realize the Current Situation of COPD Patients in China
Official title: REALizing and Improving Management of Stable COPD in China--A Multi-centre, Prospective, Observational Study to Realize the Current Situation of COPD Patients in China.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease COPD
Keywords: COPD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2017-04-27
Enrollment: 5020
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Approximately 5000 patients with COPD will be enrolled from 50 tertiary and secondary hospitals in six geographic regions around China in order to recruit a nationally representative study population from 2017 Q2 to 2018 Q2.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The mean rate of COPD exacerbations
timeFrame: within one year
measure: The proportion of hospitalized patients
timeFrame: within one year
measure: The distribution of different severity of COPD exacerbations
timeFrame: within one year
measure: The mean reduction value of available FEV1
timeFrame: within one year
measure: The mean change in CAT
timeFrame: within one year
measure: The mean change in mMRC
timeFrame: within one year
measure: The mean change in COPD-Q
timeFrame: within one year
measure: The mean rate of COPD exacerbations by different severity of COPD patients by airway limitation / by A/B/C/D at baseline.
timeFrame: within one year
measure: The proportion of hospitalized patients by different severity of COPD patients by airway limitation / by A/B/C/D at baseline
timeFrame: within one year
measure: The mean reduction value of available FEV1 by different severity of COPD by airway limitation / by A/B/C/D patients after one year from baseline
timeFrame: within one year
Secondary outcomes:
measure: The distribution of different severity of COPD patients
timeFrame: within one year
measure: Distribution of stable COPD medications in mono in total population by drug class
timeFrame: within one year
measure: Distribution of stable COPD medications by drug class according to the severity by airway limitation / by A/B/C/D patients
timeFrame: within one year
measure: Distribution of medications for COPD exacerbations by drug class including hospital prescribed and pharmacy bought
timeFrame: within one year
measure: Distribution of non-drug treatments
timeFrame: within one year
measure: Patients drug compliance
timeFrame: within one year
measure: Mean total direct COPD cost
timeFrame: within one year
measure: Distribution of prescribed stable COPD medications by drug class at each usual visit.
timeFrame: within one year
measure: Distribution of stable COPD dosage by drug class according to the severity by airway limitation / by A/B/C/D patients at baseline and after one year.
timeFrame: Within one year
measure: Distribution of stable COPD frequency by drug class according to the severity by airway limitation / by A/B/C/D patients at baseline and after one year.
timeFrame: Within one year
measure: Patients visit compliance
timeFrame: Within one year
measure: Distribution of stable COPD medications in combination in total population by drug class
timeFrame: Within one year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
Study officials:
References:
citation: 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.
citation: 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.