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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| To describe the baseline Demographic data characterisics of outpatients with moderate and severe COPD. | Demographic data
| 52 weeks of retrospective data before visit 1 |
| To describe the baseline Negative lifestyle factors characterisics of outpatients with moderate and severe COPD. | 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. | 52 weeks of retrospective data before visit 1 |
| To describe the baseline Anthropometry data characterisics of outpatients with moderate and severe COPD. | Anthropometry data 7. Mean body mass index (BMI) at inclusion (in previous 52 weeks (the most recent available value) or evaluated on Visit 1); | 52 weeks of retrospective data before visit 1 |
| To describe the baseline COPD drug treatment duration in previous 52 weeks of outpatients with moderate and severe COPD. | 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):
a) Macrolide antibiotics b) CS |
| Measure | Description | Time Frame |
|---|---|---|
| To describe the proportion of patients receiving different classes of drugs for treatment of COPD between V1 and V2 | the proportion of patients with prescribed of the following classes of drug or their combinations. The combinations may be prescribed as separate drugs or fixed combination (of ≥1 drug class in one medication):
|
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Inclusion Criteria:
Exclusion Criteria:
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2000 adult patients with diagnosed moderate-to-severe COPD and ≥2 moderate or ≥1 severe exacerbations in previous 52 weeks despite two inhaled maintenance therapies (LABA/LAMA, ICS/LABA, ICS/LAMA) for at least 6 weeks prior to inclusion and are monitored and treated by pulmonologists or general practitioners
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research site | Ivanovo | Russia | ||||
| Research site |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| 52 weeks of retrospective data before visit 1 |
| To describe the baseline Cardiovascular diseases of outpatients with moderate and severe COPD. | 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); | 52 weeks of retrospective data before visit 1 |
| To describe the baseline other comorbidities of outpatients with moderate and severe COPD. | 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). | 52 weeks of retrospective data before visit 1 |
| To describe the baseline Blood eosinophils count of outpatients with moderate and severe COPD. | 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):
| 52 weeks of retrospective data before visit 1 |
| To describe the baseline mean smoking index . | applicable for current/former tobacco smokers (pack-years) | 52 weeks of retrospective data before visit 1 |
| To describe the baseline mean duration of smoking | applicable for current/former e-cigarettes (vapes) smokers (years); | 52 weeks of retrospective data before visit 1 |
| To describe the Proportion of patients with overweight | determined as BMI ≥25 kg/m2 at inclusion (in previous 52 weeks (the most recent available value) or evaluated on Visit 1 | 52 weeks of retrospective data before visit 1 |
| To describe the baseline dosages of COPD drug treatment in previous 52 weeks of outpatients with moderate and severe COPD. | 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):
a) dosage Macrolide antibiotics b) dosage CS | 52 weeks of retrospective data before visit 1 |
| To describe the baseline proportion of patients with heart failure of outpatients with moderate and severe COPD. | 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); | 52 weeks of retrospective data before visit 1 |
| To describe the baseline data of LVEF of patients with heart failure of outpatients with moderate and severe COPD. | 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); | 52 weeks of retrospective data before visit 1 |
| To describe the baseline proportion of patients with each CKD stage - C1, C2, C3a, C3b, C4, C5 of outpatients with moderate and severe COPD. | 14. to be calculated in patients with presence of CKD before or on Visit 1. | 52 weeks of retrospective data before visit 1 |
| To describe the baseline mean office BP (SBP and DBP) measured at Visit 1 of outpatients with moderate and severe COPD. | 15. this parameter evaluated in total population and in patients with presence of AH before or on Visit 1) | 52 weeks of retrospective data before 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. | 16. to be evaluated in patients with presence of AH before or on Visit 1; | 52 weeks of retrospective data before 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. | 17. to be evaluated in patients with at least one cardiovascular disease | 52 weeks of retrospective data before visit 1 |
| 24 weeks after visit 1 |
| To describe Healthcare resource utilization during 24-week prospective study follow-up compared to baseline period | 7. Proportion of patients with healthcare resource utilization events due to COPD during 52 weeks prior to inclusion (Visit 1):
| 24 weeks after visit 1 |
| To describe changes of Mean forced expiratory volume during 24-week prospective study follow-up compared to baseline | 11. Mean parameters of lung function at inclusion (Visit 1) and Visit 2: a. Mean forced expiratory volume in 1 second (pre- and post-FEV1); 12. change from baseline (Visit 1) to Visit 2: a. Pre- and post-bronchodilator FEV1; | 24 weeks after visit 1 |
| To describe Change in CAT score during 24-week prospective study follow-up compared to baseline | 13. Mean baseline in the COPD Assessment Test (CAT) score at inclusion; 14. Mean change from baseline (at inclusion) to 24 weeks (Visit 2) in the CAT score; | 24 weeks after visit 1 |
| To describe Newly occurred cardiovascular diseases and other comorbidities during 24-week prospective study follow-up | 16. The proportion of patients with newly occurred 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; pulmonary embolism) during study follow-up, the analysis includes withdrawn patients; 17. The proportion of patients with newly occurred other (non-cardiovascular) comorbidities during study follow-up, the analysis includes withdrawn patients. | 24 weeks after visit 1 |
| To describe Blood eosinophils count during 24-week prospective study follow-up compared to baseline | 18. Mean blood eosinophils count (cells/μl) on Visit 2; 19. Proportion of patients with different levels of blood eosinophils count on Visit 2:
| 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 | 3.Proportion of patients with CS prescribed during the study between Visit 1 and Visit 2 - overall and by type (CS intermittent; CS regularly); | 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 | prescribed during the study between Visit 1 and Visit 2. | 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 | between V1 and V2 compared to the baseline period (change in drug class: SABA alone, LABA alone, LAMA alone, ICS alone, open and fixed combination of ICS, LABA or LAMA, macrolide antibiotics; CS: intermittent or regularly; or starting of triple therapy with ICS/LABA/LAMA); | 24 weeks after visit 1 |
| To describe Mean duration of COPD-related hospitalizations during 52 weeks prior to inclusion | will be described at Visit 1 | 52 weeks of retrospective data before visit 1 |
| To describe Mean duration of COPD-related hospitalizations during 24-week prospective study follow-up compared to baseline period | occurred from inclusion (Visit 1) to Visit 2. | 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 | Determined as 2 or more points after 24 weeks from 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 | evaluated in patients with CS prescribed during the study | 24 weeks after visit 1 |
| To describe Proportion of patients with CS using for COPD exacerbations treatment during the study | between Visit 1 and Visit 2 during 24-week prospective study follow-up and change in therapy dose compared to baseline period | 24 weeks after visit 1 |
| To describe proportion of patients with COPD-related disability present at the inclusion | for each disability group (I, II, III) | at visit 1 |
| To describe proportion of patients with COPD-related disability changing during study follow-up | by disability group (I, II, III) assigned at the changing (to be evaluated in patients with disability present at Visit 1) | 24 weeks after visit 1 |
| To describe proportion of patients with COPD-related disability newly established during study follow-up | by disability group (I, II, III) assigned at the establishing (to be evaluated in patients with disability absent at Visit 1). | 24 weeks after visit 1 |
| To describe proportion of patients with atrial fibrillation/flutter, ventricular arrhythmias, other arrhythmia | be calculated in patients with arrhythmia diagnosed during study follow-up | 24 weeks after visit 1 |
| To describe proportion of patients with each heart failure phenotype based on LVEF - HFrEF, HFmrEF, HFpEF | to be calculated in patients with heart failure diagnosed during study follow-up | 24 weeks after visit 1 |
| To describe Mean and median value of LVEF, % | to be calculated in patients with heart failure diagnosed during study follow-up and available data on LVEF based on echocardiography; | 24 weeks after visit 1 |
| To describe proportion of patients with decompensation of previously diagnosed heart failure | to be calculated in patients with heart failure diagnosed before or at Visit 1; | 24 weeks after visit 1 |
| To describe proportion of patients with each CKD stage - C1, C2, C3a, C3b, C4, C5 | to be calculated in patients with CKD diagnosed during study follow-up; | 24 weeks after visit 1 |
| To describe proportion of patients with each type of stroke occurred during the study follow-up - ischemic, hemorrhagic | to be calculated in patients with stroke occurred during study follow-up; | 24 weeks after visit 1 |
| To describe mean office BP (SBP and DBP) measured at Visit 2 | this parameter evaluated in total population and in patients with AH diagnosis established at any time; | 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 | to be evaluated in patients with AH diagnosis established at any time; | 24 weeks after visit 1 |
| To describe proportion of patients with various classes of medications used for treatment of CVD | to be evaluated in patients with at least one cardiovascular disease from listed above; | 24 weeks after visit 1 |
| Moscow |
| Russia |
| Research site "OOO Energy of health" | Saint Petersburg | Russia |
| Research site | Saint Petersburg | Russia |
| Research site | Voronezh | Russia |
| Research site | Yekaterinburg | Russia |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |