Realize the Current Situation of COPD Patients in China (REAL)
2022年1月11日 更新者：AstraZeneca
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.
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.
調査の概要
状態
完了
詳細な説明
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.
研究の種類
観察的
入学 (実際)
5020
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
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Beijing、中国、100029
- Research Site
-
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
確率サンプル
調査対象母集団
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.
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The mean rate of COPD exacerbations
時間枠：within one year
|
The mean rate of COPD exacerbations (acute exacerbation number per patient per year).
|
within one year
|
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The proportion of hospitalized patients
時間枠：within one year
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The proportion of hospitalized patients due to the COPD exacerbations within one year；
|
within one year
|
|
The distribution of different severity of COPD exacerbations
時間枠：within one year
|
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
|
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The mean reduction value of available FEV1
時間枠：within one year
|
The mean reduction value of available FEV1 after one year from baseline
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within one year
|
|
The mean change in CAT
時間枠：within one year
|
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
|
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The mean change in mMRC
時間枠：within one year
|
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
時間枠：within one year
|
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.
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within one year
|
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The mean rate of COPD exacerbations by different severity of COPD patients by airway limitation / by A/B/C/D at baseline.
時間枠：within one year
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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.
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within one year
|
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The proportion of hospitalized patients by different severity of COPD patients by airway limitation / by A/B/C/D at baseline
時間枠：within one year
|
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.
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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
時間枠：within one year
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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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The distribution of different severity of COPD patients
時間枠：within one year
|
The distribution will be measured by the percentage of patient on each level of severity of COPD patients by airway limitation / by A/B/C/D patients at baseline and after one year.
The calculation will be based on non-missing data.
|
within one year
|
|
Distribution of stable COPD medications in mono in total population by drug class
時間枠：within one year
|
The distribution will be measured by the percentage of patient on each kind of stable COPD medications in mono in total population by drug class (ICS[inhaled corticosteroid], LABA[long-acting beta2-agonist], ICS/LABA[combination long-acting beta2-agonists plus corticosteroids in one inhaler], SABA[short-acting beta2-agonist], SAMA[short-acting muscarinic antagonist], SABA/SAMA [combination short-acting beta2-agonist plus anticholinergic], LAMA[long-acting muscarinic antagonist], methylxanthines, mucolytic, traditional Chinese medicine and others [antibiotics, systemic corticosteroids, vaccines, antioxidant agents, etc]) at baseline and after one year.
The calculation will be based on non-missing data.
|
within one year
|
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Distribution of stable COPD medications by drug class according to the severity by airway limitation / by A/B/C/D patients
時間枠：within one year
|
The distribution will be measured by the percentage of stable COPD medications by drug class (ICS[inhaled corticosteroid], LABA[long-acting beta2-agonist], ICS/LABA[combination long-acting beta2-agonists plus corticosteroids in one inhaler], SABA[short-acting beta2-agonist], SAMA[short-acting muscarinic antagonist], SABA/SAMA [combination short-acting beta2-agonist plus anticholinergic], LAMA[long-acting muscarinic antagonist], methylxanthines, mucolytic, traditional Chinese medicine and others [antibiotics, systemic corticosteroids, vaccines, antioxidant agents, etc]) according to the severity by airway limitation / by A/B/C/D patients at baseline and after one year.
The calculation will be based on non-missing data.
|
within one year
|
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Distribution of medications for COPD exacerbations by drug class including hospital prescribed and pharmacy bought
時間枠：within one year
|
The distribution will be measured by the percentage of patient on each kind of medications for COPD exacerbations by drug (short-acting bronchodilators, corticosteroids, antibiotics and others) including hospital prescribed and pharmacy bought.
The calculation will be based on non-missing data.
|
within one year
|
|
Distribution of non-drug treatments
時間枠：within one year
|
The distribution will be measured by the percentage of patient on each kind of non-drug treatments (health education, smoking cessation, exercise of respiratory function and vaccine injection) during the study.
The calculation will be based on non-missing data.
|
within one year
|
|
Patients drug compliance
時間枠：within one year
|
Patients drug compliance (actual drug taken days/actually prescribed days, and actual drug taken dosage/actually prescribed dosage)
|
within one year
|
|
Mean total direct COPD cost
時間枠：within one year
|
Mean total direct COPD cost of the whole year per patient including the stable COPD management cost (medications and non-drug treatments) and the COPD exacerbations cost.
|
within one year
|
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Distribution of prescribed stable COPD medications by drug class at each usual visit.
時間枠：within one year
|
The distribution will be measured by the percentage of patient on each kind of prescribed stable COPD medications by drug class (ICS[inhaled corticosteroid], LABA[long-acting beta2-agonist], ICS/LABA[combination long-acting beta2-agonists plus corticosteroids in one inhaler], SABA[short-acting beta2-agonist], SAMA[short-acting muscarinic antagonist], SABA/SAMA [combination short-acting beta2-agonist plus anticholinergic], LAMA[long-acting muscarinic antagonist], methylxanthines, mucolytic, traditional Chinese medicine and others [antibiotics, systemic corticosteroids, vaccines, antioxidant agents, etc]) on each usual care visit.
The calculation will be based on non-missing data.
|
within one year
|
|
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.
時間枠：Within one year
|
The distribution will be measured by the percentage of patient on each kind 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.
The calculation will be based on non-missing data.
|
Within one year
|
|
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.
時間枠：Within one year
|
The distribution will be measured by the percentage of patient on each level of stable COPD frequency by drug class ( same as above) according to the severity by airway limitation / by A/B/C/D patients at baseline and after one year. The calculation will be based on non-missing data. |
Within one year
|
|
Patients visit compliance
時間枠：Within one year
|
Patients visit compliance (the mean usual care visit times per patient per year, and the dropout rate at each visit including V0, V1 and TC visits)
|
Within one year
|
|
Distribution of stable COPD medications in combination in total population by drug class
時間枠：Within one year
|
The distribution will be measured by the percentage of patient on each kind of stable COPD medications in combination in total population by drug class (ICS[inhaled corticosteroid], LABA[long-acting beta2-agonist], ICS/LABA[combination long-acting beta2-agonists plus corticosteroids in one inhaler], SABA[short-acting beta2-agonist], SAMA[short-acting muscarinic antagonist], SABA/SAMA [combination short-acting beta2-agonist plus anticholinergic], LAMA[long-acting muscarinic antagonist], methylxanthines, mucolytic, traditional Chinese medicine and others [antibiotics, systemic corticosteroids, vaccines, antioxidant agents, etc]) at baseline and after one year.
The calculation will be based on non-missing data.
|
Within one year
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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. Erratum In: Respir Res. 2022 Jun 18;23(1):159.
- 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.
便利なリンク
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年6月30日
一次修了 (実際)
2020年8月6日
研究の完了 (実際)
2020年8月6日
試験登録日
最初に提出
2017年3月20日
QC基準を満たした最初の提出物
2017年4月24日
最初の投稿 (実際)
2017年4月27日
学習記録の更新
投稿された最後の更新 (実際)
2022年1月26日
QC基準を満たした最後の更新が送信されました
2022年1月11日
最終確認日
2022年1月1日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD 共有時間枠
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.
IPD 共有アクセス基準
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.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
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いいえ
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いいえ
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