Clinical and dEmographic chaRacteristics of Patients With Frequent COPD Exacerbations and Evaluation of Therapeutic Approaches in Treatment in Moscow
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- To describe the baseline mean age of outpatients with COPD in Moscow.
概览
简要总结
This Study is multicenter, non-interventional, ambispective registry to evaluate the demographic and clinical characteristics, therapeutic approaches and outcomes in COPD outpatients with frequent exacerbations in Moscow
详细描述
This ambispective study consists of retrospective and prospective parts:
- Retrospective part aims to describe the demographic and clinical characteristics, as well as therapeutic approaches in COPD outpatients with frequent exacerbations during the 52 weeks prior to screening;
- Prospective part aims to evaluate current therapeutic approaches for such patients and their outcomes in real-world clinical practice.
The patient participation in the study will include two visits:
- Visit 1 - baseline: inclusion into the study, retrospective collection of medical history and data on COPD course and treatment during the previous 52 weeks, and primary data collection trough patient interview and physician assessment;
- Visit 2 - follow-up at Week 24 (±6): primary data collection trough patient interview and physician assessment.
All visits will be conducted by a study physician in accordance with routine clinical practice for the observation and management of COPD patients. For each eligible patient, the study physician will collect data in an individual electronic Case Report Form (eCRF) based on source medical documentation.
Expected duration of the inclusion period is 12 months OR until 500 eligible patients are included into the study, whichever occurs first. Overall expected duration of the study (from the first patient inclusion to the last patient last visit) is approximately 25 months.
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;
- •Confirmed diagnosis of moderate-to-very severe (GOLD 2-4) COPD established by spirometry demonstrating a post-bronchodilator ratio of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) \<0.7 obtained outside an exacerbation;
- •≥2 moderate or ≥1 severe COPD exacerbations in previous 52 weeks;
- •Dual inhaled maintenance therapy (LABA/LAMA, ICS/LAMA, or ICS/LABA) for at least 6 weeks prior to screening
排除标准
- •Current or previous treatment with triple combination (ICS/LAMA/LABA) as maintenance therapy within 52 weeks prior to screening visit;
- •COPD due to documented alpha-1-antitrypsin deficiency;
- •A diagnosis of bronchiectasis, sarcoidosis, interstitial lung diseases, or idiopathic pulmonary fibrosis, exacerbation of 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 interventional clinical study currently or within 52 weeks prior to inclusion; participation in non-interventional, observational registries without protocol-driven treatment changes does not constitute an exclusion
结局指标
主要结局
To describe the baseline mean age of outpatients with COPD in Moscow.
时间窗: 52 weeks of retrospective data before visit 1
1. Mean age (years) at inclusion, and proportion of patients within different age groups: 1. \<50 years; 2. 50-65 years; 3. \>65 years; 2. Mean age (years) at the primary COPD diagnosis;
To describe the baseline Demographic data characterisics of outpatients with COPD in Moscow.
时间窗: 52 weeks of retrospective data before visit 1
3\. Proportion of men and women; 4. Proportion of patients with different educational status at inclusion: 1. Higher education; 2. Secondary special education; 3. Secondary general education.
To describe the baseline Negative lifestyle factors of outpatients with COPD in Moscow.
时间窗: 52 weeks of retrospective data before visit 1
5\. Proportion of patients with different negative lifestyle factors at inclusion (evaluated at Visit 1 based on patient interview): a. Proportion of patients with history of smoking (former smokers) and current smokers - applicable for both tobacco and e-cigarettes (vapes) smokers; d. Proportion of patient with physical inactivity. 7. Proportion of overweight patients
To describe the baseline Anthropometry data characterisics of outpatients with COPD in Moscow.
时间窗: 52 weeks of retrospective data before visit 1
6\. Mean body mass index (BMI) (kg/m2) at inclusion (evaluated at Visit 1 or the most recent available value obtained within the previous 52 weeks if cannot be measured at Visit 1);
To describe the baseline mean smoking index .
时间窗: 52 weeks of retrospective data before visit 1
5 b. applicable for former and current tobacco smokers;
To describe the baseline mean duration of smoking
时间窗: 52 weeks of retrospective data before visit 1
5 c. applicable for former and current e cigarettes (vapes) smokers;
To describe a COPD clinical course of outpatients with COPD in Moscow
时间窗: 52 weeks of retrospective data before visit 1
8\. Proportion of patients with different COPD severity based on GOLD classification at inclusion: 1. GOLD 2 (moderate); 2. GOLD 3 (severe); 3. GOLD 4 (very severe); 9. Proportion of patients who have experienced at least 1 moderate COPD exacerbation during 52 weeks prior to inclusion; 11. Proportion of patients who have experienced at least 1 severe COPD exacerbation during 52 weeks prior to inclusion; 12. Proportion of patients who have experienced different numbers of severe COPD exacerbations during 52 weeks prior to inclusion: a. 0 severe COPD exacerbations; b. 1 severe COPD exacerbation; c. 2 severe COPD exacerbations; d. ≥3 severe COPD exacerbations;
To describe a COPD exacerbation of outpatients with COPD in Moscow
时间窗: 52 weeks of retrospective data before visit 1
10\. Annualized rate of moderate COPD exacerbations prior to inclusion 13. Annualized rate of severe COPD exacerbations prior to inclusion
To describe a severe COPD exacerbation of outpatients with COPD in Moscow
时间窗: 52 weeks of retrospective data before visit 1
14\. Cumulative days of severe COPD exacerbations prior to inclusion
To describe a COPD drug therapy of outpatients with COPD in Moscow
时间窗: 52 weeks of retrospective data before visit 1
15\. Proportion of patients receiving different classes of drugs for treatment of COPD (both maintenance therapy and exacerbation management) and their combinations (administered either as separate agents or as fixed combination) prior to inclusion: 1. Short-Acting β2-Adrenergic Agonist (SABA) alone; 2. ICS alone; 3. LABA alone; 4. LAMA alone; 5. LABA/LAMA; 6. ICS/LABA; 7. ICS/LAMA; 8. LABA/LAMA plus: a) Macrolide antibiotics; b) Systemic corticosteroids.
To describe a Spirometry parameters at baseline of outpatients with COPD in Moscow
时间窗: 52 weeks of retrospective data before visit 1
16\. Mean pre-bronchodilator FEV1 at inclusion (the most recent available value obtained within the previous 52 weeks outside of an exacerbation); 17. Mean post-bronchodilator FEV1 at inclusion (the most recent available value obtained within the previous 52 weeks outside of an exacerbation); 18. Mean FVC at inclusion (the most recent available value obtained within the previous 52 weeks outside of an exacerbation);
To describe a FEV1 / FVC ratio at baseline of outpatients with COPD in Moscow
时间窗: 52 weeks of retrospective data before visit 1
19\. Mean post-bronchodilator FEV1 / FVC ratio at inclusion (the most recent available value obtained within the previous 52 weeks outside of an exacerbation).
To describe Blood eosinophils count at baseline of outpatients with COPD in Moscow
时间窗: 52 weeks of retrospective data before visit 1
20\. Mean blood eosinophils count (cells/μl) at inclusion (the most recent available value obtained within the previous 52 weeks); 21. Proportion of patients with different levels of blood eosinophils count at inclusion (based on the most recent available value obtained within the previous 52 weeks): 1. \<150 cells/μl; 2. 150-300 cells/μl; 3. ≥301 cells/μl.
To describe CAT questionnaire score at baseline of outpatients with COPD in Moscow
时间窗: 52 weeks of retrospective data before visit 1
22\. Mean COPD Assessment Test (CAT) score at inclusion (evaluated at Visit 1 or the most recent available value obtained within the previous 6 weeks if evaluation at Visit 1 is not possible).
To describe Healthcare resource utilization of outpatients with COPD in Moscow
时间窗: 52 weeks of retrospective data before visit 1
23\. Proportion of patients with healthcare resource utilization events during 52 weeks prior to inclusion: 1. Unscheduled outpatient visits due to COPD; 2. Emergency department visits / emergency calls due to COPD; 3. Hospitalizations: a) Any hospitalizations; b) COPD-related hospitalizations; c) Hospitalizations due to respiratory reason; d) Hospitalizations due to cardiovascular reason; e) Hospitalizations due to other reason; 24. Mean duration of COPD-related hospitalizations (days) during 52 weeks prior to inclusion; 25. Proportion of patients with COPD-related disability at inclusion: 1. Any disability; 2. I disability group; 3. II disability group; 4. III disability group
To describe COPD comorbidities at baseline of outpatients with COPD in Moscow
时间窗: 52 weeks of retrospective data before visit 1
26\. Proportion of patients with different comorbidities at inclusion (diagnosed by study physician at Visit 1 or diagnosed at any time previously and recorded based on medical documentation or patient interview): 1. Heart failure 2. Ischemic heart disease 3. Myocardial infarction 4. Arrhythmia 5. Stroke 6. Arterial hypertension 7. Peripheral arterial disease 8. Diabetes mellitus (type I, type II) 9. Chronic kidney disease 10. Pulmonary hypertension 11. Pulmonary embolism 12. Another comorbidity 27. Proportion of patients with different types of arrythmia at inclusion (to be calculated in the subgroup of patients with any arrhythmia before or at Visit 1): a. Atrial fibrillation / atrial flutter; b. Ventricular arrhythmia; c. Another arrhythmia;
To describe COPD and Heart Failure comorbidity at baseline of outpatients with COPD in Moscow
时间窗: 52 weeks of retrospective data before visit 1
28\. Proportion of patients with each HF phenotype based on left ventricle ejection fraction (LVEF) at inclusion (to be calculated in the subgroup of patients with any HF before or at Visit 1): 1. HF with reduced ejection fraction (HFrEF); 2. HF with mid-range ejection fraction (HFmrEF); 3. HF with preserved ejection fraction (HFpEF);
To describe LVEF at baseline of outpatients with COPD in Moscow
时间窗: 52 weeks of retrospective data before visit 1
29\. Mean and median LVEF (%) at inclusion (to be calculated in the subgroup of patients with any HF before or at Visit 1 and available data on LVEF based on echocardiography);
To describe COPD and Chronic Kidney Disease comorbidity at baseline of outpatients with COPD in Moscow
时间窗: 52 weeks of retrospective data before visit 1
30\. Proportion of patients with each CKD stage based on estimated glomerular filtration rate (eGFR) at inclusion (to be calculated in the subgroup of patients with any CKD before or at Visit 1): 1. Stage C1 (eGFR ≥90 ml/min/1.73 m2); 2. Stage C2 (eGFR 89-60 ml/min/1.73 m2); 3. Stage C3a (eGFR 59-45 ml/min/1.73 m2); 4. Stage C3b (eGFR 44-30 ml/min/1.73 m2); 5. Stage C4 (eGFR 29-15 ml/min/1.73 m2); 6. Stage C5 (eGFR \<15 ml/min/1.73 m2);
To describe COPD and Arterial Hypertension (AH) comorbidity at baseline of outpatients with COPD in Moscow
时间窗: 52 weeks of retrospective data before visit 1
31\. Proportion of patients with each AH degree at inclusion (to be evaluated in patients with AH diagnosed before or at Visit 1): 1. 1st degree of AH; 2. 2nd degree of AH; 3. 3rd degree of AH; 32. Proportion of patients with each AH stage at inclusion (to be evaluated in patients with AH diagnosed before or at Visit 1): a. Stage I; b. Stage II; c. Stage III; 33. Proportion of patients with risk category at inclusion (to be evaluated in patients with AH diagnosed before or at Visit 1): 1. Low risk; 2. Intermediate risk; 3. High risk; 4. Very high risk;
To describe blood pressure at baseline of outpatients with COPD in Moscow
时间窗: at visit 1
34\. Mean office systolic blood pressure (SBP) (mmHg) measured at inclusion (in total population and by presence of AH diagnosed before or at Visit 1); 35. Mean office diastolic blood pressure (DBP) (mmHg) measured at inclusion (in total population and by presence of AH diagnosed before or at Visit 1);
To describe a treatment of comorbidities at baseline of outpatients with COPD in Moscow
时间窗: at visit 1
36\. Proportion of patients receiving different classes of medications used for treatment of comorbidities (to be evaluated in the subgroup of patients with at least one comorbidity specified above in paragraph #26)
次要结局
- To describe COPD drug therapy during the follow-up period and its change compared to the previous 52 weeks(24 weeks after visit 1)
- To describe corticosteroid therapy during the follow-up period of outpatients with COPD in Moscow(24 weeks after visit 1)
- To describe changes of inhaled COPD therapy during the follow-up period of outpatients with COPD in Moscow(24 weeks after visit 1)
- To describe COPD therapy during the follow-up period of outpatients with COPD in Moscow(24 weeks after visit 1)
- To describe COPD clinical course during the follow-up period and its change compared to the previous 52 weeks of outpatients with COPD in Moscow(24 weeks after visit 1)
- To describe exacerbations of outpatients with COPD in Moscow(24 weeks after visit 1)
- To describe Spirometry parameters during follow-up period and their change compared to the previous 52 weeksof outpatients with COPD in Moscow(24 weeks after visit 1)
- To describe Spirometry FEV1 / FVC ratio during follow-up period and their change compared to the previous 52 weeks of outpatients with COPD in Moscow(24 weeks after visit 1)
- To describe Blood eosinophils count during follow-up period and its change compared to the previous 52 weeks of outpatients with COPD in Moscow(24 weeks after visit 1)
- To describe Proportion of patients with different levels of blood eosinophils count of outpatients with COPD in Moscow(24 weeks after visit 1)
- To describe CAT questionnaire score during follow-up period and its change compared to the previous 52 weeks of outpatients with COPD in Moscow(24 weeks after visit 1)
- To describe Proportion of responders based on CAT score of outpatients with COPD in Moscow(24 weeks after visit 1)
- To describe Healthcare resource utilization during follow-up period and its change compared to the previous 52 weeks of outpatients with COPD in Moscow(24 weeks after visit 1)
- To describe hospitalization during follow-up period and its change compared to the previous 52 weeks of outpatients with COPD in Moscow(24 weeks after visit 1)
- To describe COPD comorbidities during the follow-up period and their change compared to the previous 52 weeks of outpatients with COPD in Moscow(24 weeks after visit 1)
- To describe disability during follow-up period of outpatients with COPD in Moscow(24 weeks after visit 1)
- To describe LVEF during follow-up period of outpatients with COPD in Moscow(24 weeks after visit 1)
- To describe blood pressure during follow-up period of outpatients with COPD in Moscow(24 weeks after visit 1)
- To describe adverse drug reactions during follow-up period of outpatients with COPD in Moscow(24 weeks after visit 1)