Realize the Current Situation of COPD Patients in China

NCT03131362 | Completed

• 1 other identifier: D2287R00114
• Study Type: observational
• Target: 5,020
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease COPD

Keywords

COPD

Outcome Measures

Primary Outcomes (10)

• The mean rate of COPD exacerbations

  The mean rate of COPD exacerbations (acute exacerbation number per patient per year).

  within one year

• The proportion of hospitalized patients

  The proportion of hospitalized patients due to the COPD exacerbations within one year；

  within one year

• The distribution of different severity of COPD exacerbations

  The distribution will be measured by percentage of patient on each level of severity of COPD exacerbations (mild: requiring an increase in rescue medication≥ 3 puffs / day for at least 2 consecutive days; moderate: requiring systemic glucocorticosteroids and/or antibiotics; severe: hospitalization, emergency room visit or leading to death), the calculation will be based on non-missing data.

  within one year

• The mean reduction value of available FEV1

  The mean reduction value of available FEV1 after one year from baseline

  within one year

• The mean change in CAT

  The mean change in CAT total scores after one year from baseline; COPD assessment test (CAT) total score will be derived by summing up the score of all items. Total Scores range 0-40.The COPD influence on patients: 1 stage (mild): 0-10 points; 2 stage (moderate): 11-20 points; 3 stage (severe):21-30 points; 4 stage (very severe):31-40 points.

  within one year

• The mean change in mMRC

  The mean change in mMRC results after one year from baseline. Modified Medical Research Council Questionnaire (mMRC) will be assessed according to the severity of breathlessness as below: Grade 0 I only get breathless with strenuous exercise Grade 1 I get short of breath when hurrying on the level or walking up a slight hill Grade 2 I walk slower than people of the same age on the level because of breathlessness, or I have to stop for breath when walking on my own pace on the level Grade 3 I stop for breath after walking about 100 meters or after a few minutes on the level Grade 4 I am too breathless to leave the house or I am breathless when dressing or undressing

  within one year

• The mean change in COPD-Q

  The mean change in COPD patients' cognition questionnaire (COPD-Q) total scores after one year from baseline. COPD knowledge Questionnaire (COPD-Q) total score will be derived by summing up the scores from 13 items evaluating patients knowledge and understanding to COPD including 8 forward items: 1point (true), 0 point (false or not sure); 5 reverse items: 1 point (false), 0 point (true or not sure). Then get the total scores.

  within one year

• The mean rate of COPD exacerbations by different severity of COPD patients by airway limitation / by A/B/C/D at baseline.

  The mean rate of COPD exacerbations (acute exacerbation number per patient per year) by different severity of COPD patients by airway limitation / by A/B/C/D at baseline according to GOLD 2016.

  within one year

• The proportion of hospitalized patients by different severity of COPD patients by airway limitation / by A/B/C/D at baseline

  The proportion of hospitalized patients due to the COPD exacerbations by different severity of COPD patients by airway limitation / by A/B/C/D at baseline within one year according to GOLD 2016.

  within one year

• 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

  The mean reduction value of available FEV1 by different severity of COPD by airway limitation / by A/B/C/D patients according to GOLD 2016 after one year from baseline

  within one year

Secondary Outcomes (12)

• The distribution of different severity of COPD patients

  within one year

• Distribution of stable COPD medications in mono in total population by drug class

  within one year

• Distribution of stable COPD medications by drug class according to the severity by airway limitation / by A/B/C/D patients

  within one year

• Distribution of medications for COPD exacerbations by drug class including hospital prescribed and pharmacy bought

  within one year

• Distribution of non-drug treatments

  within one year

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Beijing, 100029, China

Location

Related Publications (5)

• 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.

  PMID: 37318116 DERIVED

• 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.

  PMID: 37073797 DERIVED

• 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.

  PMID: 37013442 DERIVED

• 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.

  PMID: 35488337 DERIVED

• 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.

  PMID: 31931767 DERIVED

Related Links

• This is a CSR Synopsis.

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 Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: April 27, 2017
• Study Start: June 30, 2017
• Primary Completion: August 6, 2020
• Study Completion: August 6, 2020
• Last Updated: January 26, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

CN (1)