Clinical and dEmographic chaRacteristics of Patients With Frequent COPD Exacerbations and Evaluation of Therapeutic Approaches in Treatment in RussiA
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 2,038
- 试验地点
- 8
- 主要终点
- To describe the baseline proportion of patients with heart failure of outpatients with moderate and severe COPD.
研究概览
简要总结
This Study is a multicenter, non-interventional, observational, ambispective (retrospective-prospective) study to evaluate clinical and demographic characteristics, approaches to therapy in outpatients with COPD and frequent exacerbations in the Russian Federation. Planned number of Study site is 35 outpatient centers with experience of treatment of COPD with frequency exacerbations in about 30 regions in Russia.
详细描述
The study consists of a retrospective phase covering 52 weeks and a prospective phase of 24 weeks, involving 2000 patients across approximately 35 cites. Therefore, the aim of the study is to evaluate the clinical and demographic patients' characteristics based on retrospective part and COPD treatment patterns based on prospective part of patients with frequent exacerbations of COPD on dual therapy in the Russian Federation. The study results will be interpreted in the context of an open label, single arm study design. Due to the limited data available on the COPD population in Russia, the characterization of clinical and demographic characteristic of patients based on the retrospective component of the study will enhance the understanding of this patient group and the prospective aspect, which analyses therapeutic approaches, will help to assess physicians' adherence to current recommendations regarding therapy selection for COPD patients on dual therapy with frequent exacerbations.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years at the time of inclusion;
- •Signed and dated written informed consent in accordance with ICH-GCP and local law prior to inclusion in the study;
- •Patients with diagnosed moderate-to-severe COPD (see comments below);
- •≥2 moderate or ≥1 severe COPD exacerbations in previous 52 weeks (see comments below);
- •Patients have been receiving two inhaled maintenance therapies (LABA/LAMA, ICS/LABA, ICS/LAMA) for at least 6 weeks prior to inclusion.
排除标准
- •Current or previous treatment with triple combination (ICS/LABA/LAMA) within 52 weeks prior to inclusion;
- •COPD due to documented α-1 antitrypsin deficiency;
- •A diagnosis of bronchiectasis, sarcoidosis, interstitial lung diseases, or idiopathic pulmonary fibrosis, exacerbation of bronchial asthma or any acute or chronic disease that, as deemed by Investigator, limits the ability of patients to participate in this study or could influence the interpretation of the results;
- •The participation in any clinical study currently or within 52 weeks prior to inclusion.
结局指标
主要结局
To describe the baseline proportion of patients with heart failure of outpatients with moderate and severe COPD.
时间窗: 52 weeks of retrospective data before visit 1
12\. Proportion of patients will be evaluated for each heart failure phenotype based on LVEF - HFrEF, HFmrEF, HFpEF (to be calculated in patients with presence of heart failure before or on Visit 1);
To describe the baseline data of LVEF of patients with heart failure of outpatients with moderate and severe COPD.
时间窗: 52 weeks of retrospective data before visit 1
13\. Mean and median value of LVEF, % (to be calculated in patients with presence of heart failure before or on Visit 1 and available data on LVEF based on echocardiography);
To describe the baseline proportion of patients with each CKD stage - C1, C2, C3a, C3b, C4, C5 of outpatients with moderate and severe COPD.
时间窗: 52 weeks of retrospective data before visit 1
14\. to be calculated in patients with presence of CKD before or on Visit 1.
To describe the baseline mean office BP (SBP and DBP) measured at Visit 1 of outpatients with moderate and severe COPD.
时间窗: 52 weeks of retrospective data before visit 1
15\. this parameter evaluated in total population and in patients with presence of AH before or on Visit 1)
To describe the baseline proportion of patients with AH by distribution by AH stage (I, II, III), AH degree (1st, 2nd, 3rd) and risk category at Visit 1 of outpatients with moderate and severe COPD.
时间窗: 52 weeks of retrospective data before visit 1
16\. to be evaluated in patients with presence of AH before or on Visit 1;
To describe the baseline proportion of patients with various classes of medications used for treatment of CVD of outpatients with moderate and severe COPD.
时间窗: 52 weeks of retrospective data before visit 1
17\. to be evaluated in patients with at least one cardiovascular disease
To describe the baseline Demographic data characterisics of outpatients with moderate and severe COPD.
时间窗: 52 weeks of retrospective data before visit 1
Demographic data 1. Mean age at the inclusion into the study, and age groups (\<50; 50-65, \>65 years); 2. Mean age at the primary COPD diagnosis; 3. Proportion of men and women; 4. Proportion of patients with each educational status (higher, secondary special, secondary general) at inclusion; 5. Proportion of patients from each residential region of Russia;
To describe the baseline Negative lifestyle factors characterisics of outpatients with moderate and severe COPD.
时间窗: 52 weeks of retrospective data before visit 1
Negative lifestyle factors 6. Proportion of patients with negative lifestyle factors at inclusion (evaluated on Visit 1 based on patient's interview): a. Proportion of patients with history of smoking (former smoker)/current smokers - applicable for tobacco and e-cigarettes (vapes) smoking; d. Proportion of patients with overeating; e. Proportion of patient with physical inactivity.
To describe the baseline Anthropometry data characterisics of outpatients with moderate and severe COPD.
时间窗: 52 weeks of retrospective data before visit 1
Anthropometry data 7. Mean body mass index (BMI) at inclusion (in previous 52 weeks (the most recent available value) or evaluated on Visit 1);
To describe the baseline COPD drug treatment duration in previous 52 weeks of outpatients with moderate and severe COPD.
时间窗: 52 weeks of retrospective data before visit 1
9\. Proportion of patients receiving different classes of drugs for treatment of COPD during prior 52 weeks before inclusion. The following classes of drug or their combinations will be collected. The combinations may be prescribed as separate drugs or fixed combination (of ≥1 drug class in one medication): 1. SABA alone; 2. ICS alone 3. LABA alone 4. LAMA alone 5. LABA and LAMA 6. ICS and LABA 7. ICS and LAMA 8. LABA and LAMA plus: a) Macrolide antibiotics b) CS
To describe the baseline Cardiovascular diseases of outpatients with moderate and severe COPD.
时间窗: 52 weeks of retrospective data before visit 1
Cardiovascular diseases 10. Proportion of patients with cardiovascular diseases (heart failure; ischaemic heart disease; myocardial infarction; arrhythmia; stroke; arterial hypertension; peripheral arterial disease; diabetes mellitus (type I, type II); chronic kidney disease (CKD); pulmonary hypertension) at inclusion (diagnosed in medical documentation ever or identified on the Visit 1 via a patient interview);
To describe the baseline other comorbidities of outpatients with moderate and severe COPD.
时间窗: 52 weeks of retrospective data before visit 1
Other comorbidities 11. Proportion of patients with atrial fibrillation/flutter, ventricular arrhythmias, other arrhythmia (be calculated in patients with presence of arrhythmia before or on Visit 1); 18. Proportion of patients with different other comorbidities at inclusion (diagnosed in previous 52 weeks or on Visit 1).
To describe the baseline Blood eosinophils count of outpatients with moderate and severe COPD.
时间窗: 52 weeks of retrospective data before visit 1
Blood eosinophils count 19. Mean blood eosinophils count (cells/μl) at inclusion (in previous 52 weeks (the most recent available value) or evaluated on Visit 1); 20. Proportion of patients with different levels of blood eosinophils count at inclusion (in previous 52 weeks (the most recent available value) or evaluated on Visit 1): 1. \<150 cells/μl; 2. ≥150 cells/μl; 3. ≥300 cells/μl.
To describe the baseline mean smoking index .
时间窗: 52 weeks of retrospective data before visit 1
applicable for current/former tobacco smokers (pack-years)
To describe the baseline mean duration of smoking
时间窗: 52 weeks of retrospective data before visit 1
applicable for current/former e-cigarettes (vapes) smokers (years);
To describe the Proportion of patients with overweight
时间窗: 52 weeks of retrospective data before visit 1
determined as BMI ≥25 kg/m2 at inclusion (in previous 52 weeks (the most recent available value) or evaluated on Visit 1
To describe the baseline dosages of COPD drug treatment in previous 52 weeks of outpatients with moderate and severe COPD.
时间窗: 52 weeks of retrospective data before visit 1
Proportion of patients receiving different classes of drugs for treatment of COPD. The following classes of drug or their combinations will be collected. The combinations may be prescribed as separate drugs or fixed combination (of ≥1 drug class in one medication): 1. dosage SABA alone ; 2. dosage ICS alone 3. dosage LABA alone 4. dosage LAMA alone 5. dosage LABA and LAMA 6. dosage ICS and LABA 7. dosage ICS and LAMA 8. LABA and LAMA plus: a) dosage Macrolide antibiotics b) dosage CS
次要结局
- To describe proportion of patients with COPD-related disability present at the inclusion(at visit 1)
- To describe proportion of patients with COPD-related disability changing during study follow-up(24 weeks after visit 1)
- To describe proportion of patients with COPD-related disability newly established during study follow-up(24 weeks after visit 1)
- To describe proportion of patients with atrial fibrillation/flutter, ventricular arrhythmias, other arrhythmia(24 weeks after visit 1)
- To describe proportion of patients with each heart failure phenotype based on LVEF - HFrEF, HFmrEF, HFpEF(24 weeks after visit 1)
- To describe Mean and median value of LVEF, %(24 weeks after visit 1)
- To describe proportion of patients with decompensation of previously diagnosed heart failure(24 weeks after visit 1)
- To describe proportion of patients with each CKD stage - C1, C2, C3a, C3b, C4, C5(24 weeks after visit 1)
- To describe proportion of patients with each type of stroke occurred during the study follow-up - ischemic, hemorrhagic(24 weeks after visit 1)
- To describe mean office BP (SBP and DBP) measured at Visit 2(24 weeks after visit 1)
- To describe proportion of patients with AH by distribution by AH stage (I, II, III), AH degree (1st, 2nd, 3rd) and risk category at Visit 2(24 weeks after visit 1)
- To describe proportion of patients with various classes of medications used for treatment of CVD(24 weeks after visit 1)
- To describe the proportion of patients receiving different classes of drugs for treatment of COPD between V1 and V2(24 weeks after visit 1)
- To describe Healthcare resource utilization during 24-week prospective study follow-up compared to baseline period(24 weeks after visit 1)
- To describe Mean duration of COPD-related hospitalizations during 52 weeks prior to inclusion(52 weeks of retrospective data before visit 1)
- To describe changes of Mean forced expiratory volume during 24-week prospective study follow-up compared to baseline(24 weeks after visit 1)
- To describe Change in CAT score during 24-week prospective study follow-up compared to baseline(24 weeks after visit 1)
- To describe Newly occurred cardiovascular diseases and other comorbidities during 24-week prospective study follow-up(24 weeks after visit 1)
- To describe Mean duration of COPD-related hospitalizations during 24-week prospective study follow-up compared to baseline period(24 weeks after visit 1)
- To describe Blood eosinophils count during 24-week prospective study follow-up compared to baseline(24 weeks after visit 1)
- To describe COPD corticosteroid treatment during 24-week prospective study follow-up and change in therapy compared to baseline period(24 weeks after visit 1)
- To describe Proportion of patients with macrolide antibiotics during 24-week prospective study follow-up and change in therapy compared to baseline period(24 weeks after visit 1)
- To describe Proportion of patients with change of inhaled COPD therapy during the study during 24-week prospective study follow-up and change in therapy compared to baseline period(24 weeks after visit 1)
- To describe changes of Mean forced vital capacity during 24-week prospective study follow-up compared to baseline(24 weeks after visit 1)
- To describe changes of Mean post-bronchodilator FEV1/FVC ratio during 24-week prospective study follow-up compared to baseline(24 weeks after visit 1)
- To describe Percent of responders using the CAT who achieved MCID (minimal clinically important difference) during 24-week prospective study follow-up compared to baseline(24 weeks after visit 1)
- To describe Mean CS daily dose (mg/day in prednisolone equivalent) during the study between Visit 1 and Visit 2 during 24-week prospective study follow-up and change in therapy compared to baseline period(24 weeks after visit 1)
- To describe Proportion of patients with CS using for COPD exacerbations treatment during the study(24 weeks after visit 1)