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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
This ambispective study consists of retrospective and prospective parts:
The patient participation in the study will include two visits:
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.
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| Measure | Description | Time Frame |
|---|---|---|
| To describe the baseline mean age of outpatients with COPD in Moscow. |
| 52 weeks of retrospective data before visit 1 |
| To describe the baseline Demographic data characterisics of outpatients with COPD in Moscow. | 3. Proportion of men and women; 4. Proportion of patients with different educational status at inclusion:
| 52 weeks of retrospective data before visit 1 |
| To describe the baseline Negative lifestyle factors of outpatients with COPD in Moscow. | 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 | 52 weeks of retrospective data before visit 1 |
| To describe the baseline Anthropometry data characterisics of outpatients with COPD in Moscow. | 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); | 52 weeks of retrospective data before visit 1 |
| To describe the baseline mean smoking index . | 5 b. applicable for former and current tobacco smokers; | 52 weeks of retrospective data before visit 1 |
| Measure | Description | Time Frame |
|---|---|---|
| To describe COPD drug therapy during the follow-up period and its change compared to the previous 52 weeks |
|
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Inclusion Criteria:
Exclusion Criteria:
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study population consists of 500 adult patients with moderate-to-very severe COPD who have experienced ≥2 moderate or ≥1 severe exacerbations within the previous 52 weeks and received dual inhaled maintenance therapy (LABA/LAMA, ICS/LAMA, or ICS/LABA combinations, but not triple ICS/LAMA/LABA therapy) for at least 6 weeks prior to screening
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Recruiting | Moscow | Russia |
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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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| To describe the baseline mean duration of smoking | 5 c. applicable for former and current e cigarettes (vapes) smokers; | 52 weeks of retrospective data before visit 1 |
| To describe a COPD clinical course of outpatients with COPD in Moscow | 8. Proportion of patients with different COPD severity based on GOLD classification at inclusion:
a. 0 severe COPD exacerbations; b. 1 severe COPD exacerbation; c. 2 severe COPD exacerbations; d. ≥3 severe COPD exacerbations; | 52 weeks of retrospective data before visit 1 |
| To describe a COPD exacerbation of outpatients with COPD in Moscow | 10. Annualized rate of moderate COPD exacerbations prior to inclusion 13. Annualized rate of severe COPD exacerbations prior to inclusion | 52 weeks of retrospective data before visit 1 |
| To describe a severe COPD exacerbation of outpatients with COPD in Moscow | 14. Cumulative days of severe COPD exacerbations prior to inclusion | 52 weeks of retrospective data before visit 1 |
| To describe a COPD drug therapy of outpatients with COPD in Moscow | 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:
a) Macrolide antibiotics; b) Systemic corticosteroids. | 52 weeks of retrospective data before visit 1 |
| To describe a Spirometry parameters at baseline of outpatients with COPD in Moscow | 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); | 52 weeks of retrospective data before visit 1 |
| To describe a FEV1 / FVC ratio at baseline of outpatients with COPD in Moscow | 19. Mean post-bronchodilator FEV1 / FVC ratio at inclusion (the most recent available value obtained within the previous 52 weeks outside of an exacerbation). | 52 weeks of retrospective data before visit 1 |
| To describe Blood eosinophils count at baseline of outpatients with COPD in Moscow | 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):
| 52 weeks of retrospective data before visit 1 |
| To describe CAT questionnaire score at baseline of outpatients with COPD in Moscow | 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). | 52 weeks of retrospective data before visit 1 |
| To describe Healthcare resource utilization of outpatients with COPD in Moscow | 23. Proportion of patients with healthcare resource utilization events during 52 weeks prior to inclusion:
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:
| 52 weeks of retrospective data before visit 1 |
| To describe COPD comorbidities at baseline of outpatients with COPD in Moscow | 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):
a. Atrial fibrillation / atrial flutter; b. Ventricular arrhythmia; c. Another arrhythmia; | 52 weeks of retrospective data before visit 1 |
| To describe COPD and Heart Failure comorbidity at baseline of outpatients with COPD in Moscow | 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):
| 52 weeks of retrospective data before visit 1 |
| To describe LVEF at baseline of outpatients with COPD in Moscow | 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); | 52 weeks of retrospective data before visit 1 |
| To describe COPD and Chronic Kidney Disease comorbidity at baseline of outpatients with COPD in Moscow | 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):
| 52 weeks of retrospective data before visit 1 |
| To describe COPD and Arterial Hypertension (AH) comorbidity at baseline of outpatients with COPD in Moscow | 31. Proportion of patients with each AH degree 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):
| 52 weeks of retrospective data before visit 1 |
| To describe blood pressure at baseline of outpatients with COPD in Moscow | 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); | at visit 1 |
| To describe a treatment of comorbidities at baseline of outpatients with COPD in Moscow | 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) | at visit 1 |
| 24 weeks after visit 1 |
| To describe corticosteroid therapy during the follow-up period of outpatients with COPD in Moscow | 3. Mean systemic CS daily dose (mg/day in prednisolone equivalent) during follow-up period (to be evaluated in the subgroup of patients who have been receiving systemic CS during follow-up period); | 24 weeks after visit 1 |
| To describe changes of inhaled COPD therapy during the follow-up period of outpatients with COPD in Moscow | 4. Proportion of patients with different types of change of inhaled COPD therapy during the follow-up period compared to the 52 weeks prior to inclusion: a. Dosage adjustment:
| 24 weeks after visit 1 |
| To describe COPD therapy during the follow-up period of outpatients with COPD in Moscow | 4. Proportion of patients with different types of change of inhaled COPD therapy during the follow-up period compared to the 52 weeks prior to inclusion: a. Dosage adjustment:
| 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 | 6. Proportion of patients with different COPD severity based on GOLD classification at Visit 2 7. Proportion of patients with COPD progression to more severe GOLD category over the follow-up period 8. Proportion of patients with COPD improvement to less severe GOLD category over the follow-up period overall and by GOLD category at baseline 9. Proportion of patients who have experienced at least 1 COPD exacerbation during the follow-up period; 10. Proportion of patients who have experienced at least 1 moderate COPD exacerbation during the follow-up period 11. Proportion of patients who have experienced at least 1 severe COPD exacerbation during the follow-up period; 12. Proportion of patients who have experienced different numbers of severe COPD exacerbations during the follow-up period | 24 weeks after visit 1 |
| To describe exacerbations of outpatients with COPD in Moscow | 11. Annualized rate of moderate COPD exacerbations during the follow-up period 14. Annualized rate of severe COPD exacerbations during the follow-up period; 15. Cumulative days of severe COPD exacerbations during the follow-up period | 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 | 16. Mean pre-bronchodilator FEV1 at Visit 2 (the most recent available value obtained within the follow-up period outside of an exacerbation); 17. Mean change of pre-bronchodilator FEV1 from baseline to the end of the follow-up period; 18. Mean post-bronchodilator FEV1 at Visit 2 (the most recent available value obtained within the follow-up period outside of an exacerbation); 19. Mean change of post-bronchodilator FEV1 from baseline to the end of the follow-up period; 20. Mean FVC at Visit 2 (the most recent available value obtained within the follow-up period outside of an exacerbation); 21. Mean change of FVC from baseline to the end of the follow-up period; | 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 | 22. Mean post-bronchodilator FEV1 / FVC ratio at Visit 2 (the most recent available value obtained within the follow-up period outside of an exacerbation); 23. Mean change of FEV1 / FVC ratio from baseline to the end of the follow-up period | 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. Mean blood eosinophils count (cells/μl) at Visit 2 (the most recent available value obtained within the follow-up period); 25. Mean change in blood eosinophils count (cells/μl) from baseline to the end of the follow-up period; | 24 weeks after visit 1 |
| To describe Proportion of patients with different levels of blood eosinophils count of outpatients with COPD in Moscow | 26. to evaluated at Visit 2 (based on the most recent available value obtained within the follow-up period):
| 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 | 27. Mean CAT score at Visit 2 (evaluated at Visit 2 or the most recent available value obtained within the 6-week period prior to Visit 2 if evaluation at Visit 2 is not possible); 28. Mean change of CAT score from baseline to the end of the follow-up period | 24 weeks after visit 1 |
| To describe Proportion of responders based on CAT score of outpatients with COPD in Moscow | 29. defined as proportion of patients who achieved minimal clinically important difference (MCID) of 2 or more points from baseline to the end of the follow-up period. | 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 | 30. Proportion of patients with healthcare resource utilization events during the follow-up period 32. Proportion of patients with COPD-related disability at Visit 2 33. Proportion of patients with newly established COPD-related disability during the follow-up period (to be evaluated in the subgroup of patients with disability absent at inclusion) 34. Proportion of patients with the change of COPD-related disability level during the follow-up period (to be evaluated in the subgroup of patients with disability present at inclusion) | 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 | 31. Mean duration of COPD-related hospitalizations (days) during the follow-up period | 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 | 35. Proportion of patients with newly diagnosed comorbidities at Visit 2 36. Proportion of patients with different types of arrythmia newly diagnosed during the follow-up period 37. Proportion of patients with each HF phenotype based on LVEF newly diagnosed during the follow-up period 39. Proportion of patients with decompensation of previously diagnosed HF 40. Proportion of patients with each CKD stage based on eGFR newly diagnosed during the follow-up period 41. Proportion of patients with each AH degree at Visit 2 42. Proportion of patients with each AH stage at Visit 2 43. Proportion of patients with risk category at Visit 2 46. Proportion of patients receiving different classes of medications used for treatment of comorbidities | 24 weeks after visit 1 |
| To describe disability during follow-up period of outpatients with COPD in Moscow | 32. Proportion of patients with COPD-related disability at Visit 2 33. Proportion of patients with newly established COPD-related disability during the follow-up period (to be evaluated in the subgroup of patients with disability absent at inclusion) 34. Proportion of patients with the change of COPD-related disability level during the follow-up period (to be evaluated in the subgroup of patients with disability present at inclusion) | 24 weeks after visit 1 |
| To describe LVEF during follow-up period of outpatients with COPD in Moscow | 38. Mean and median LVEF (%) (to be calculated in the subgroup of patients with any HF newly diagnosed during the follow-up period and available data on LVEF based on echocardiography); | 24 weeks after visit 1 |
| To describe blood pressure during follow-up period of outpatients with COPD in Moscow | 44. Mean office SBP (mmHg) measured at Visit 2 (in total population and by presence of AH diagnosed at any time); 45. Mean office DBP (mmHg) measured at Visit 2 (in total population and by presence of AH diagnosed at any time); | 24 weeks after visit 1 |
| To describe adverse drug reactions during follow-up period of outpatients with COPD in Moscow | 47. Proportion of patients with adverse drug reactions (ADR) related to COPD treatment during the follow-up period overall and by system organ class (SOC) and preferred term (PT) of Medical Dictionary for Regulatory Activities (MedDRA), by related drug class, by seriousness, by severity and by actions taken regarding ADR and regarding related drug; 48. Proportion of patients who discontinued any COPD treatment due to ADR overall and by drug class discontinued. | 24 weeks after visit 1 |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |