Study of Patient With Frequent Exacerbations in Moscow (CERERA-MOSCOW)

Clinical and dEmographic chaRacteristics of Patients With Frequent COPD Exacerbations and Evaluation of Therapeutic Approaches in Treatment in Moscow

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• Russia
  • Moscow, Russia
    • Recruiting
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

1. Age ≥18 years at the time of inclusion;
2. Signed and dated written informed consent in accordance with ICH GCP and local law prior to inclusion in the study;
3. 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;
4. ≥2 moderate or ≥1 severe COPD exacerbations in previous 52 weeks;
5. Dual inhaled maintenance therapy (LABA/LAMA, ICS/LAMA, or ICS/LABA) for at least 6 weeks prior to screening

Exclusion Criteria:

1. Current or previous treatment with triple combination (ICS/LAMA/LABA) as maintenance therapy within 52 weeks prior to screening visit;
2. COPD due to documented alpha-1-antitrypsin deficiency;
3. 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;
4. 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To describe the baseline mean age of outpatients with COPD in Moscow.	Mean age (years) at inclusion, and proportion of patients within different age groups:<50 years;50-65 years;>65 years;; Mean age (years) at the primary COPD diagnosis;	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: Higher education;; Secondary special education;; Secondary general education.	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
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: GOLD 2 (moderate);; GOLD 3 (severe);; 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;	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: Short-Acting β2-Adrenergic Agonist (SABA) alone;; ICS alone;; LABA alone;; LAMA alone;; LABA/LAMA;; ICS/LABA;; ICS/LAMA;; LABA/LAMA plus: 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): <150 cells/μl;; 150-300 cells/μl;; ≥301 cells/μl.	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: Unscheduled outpatient visits due to COPD;; Emergency department visits / emergency calls due to COPD;; 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: Any disability;; I disability group;; II disability group;; III disability group	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): Heart failure; Ischemic heart disease; Myocardial infarction; Arrhythmia; Stroke; Arterial hypertension; Peripheral arterial disease; Diabetes mellitus (type I, type II); Chronic kidney disease; Pulmonary hypertension; Pulmonary embolism; 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;	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): HF with reduced ejection fraction (HFrEF);; HF with mid-range ejection fraction (HFmrEF);; HF with preserved ejection fraction (HFpEF);	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): Stage C1 (eGFR ≥90 ml/min/1.73 m2);; Stage C2 (eGFR 89-60 ml/min/1.73 m2);; Stage C3a (eGFR 59-45 ml/min/1.73 m2);; Stage C3b (eGFR 44-30 ml/min/1.73 m2);; Stage C4 (eGFR 29-15 ml/min/1.73 m2);; Stage C5 (eGFR <15 ml/min/1.73 m2);	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): 1st degree of AH;; 2nd degree of AH;; 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): Low risk;; Intermediate risk;; High risk;; Very high risk;	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To describe COPD drug therapy during the follow-up period and its change compared to the previous 52 weeks	Proportion of patients receiving different classes of drugs for maintenance therapy of COPD and their combinations (administered either as separate agents or as fixed combination) after Visit 1 and at Visit 2:SABA aloneICS aloneLABA aloneLAMA aloneLABA/LAMA;ICS/LABAICS/LAMALABA/LAMA/ICSAny combinationOpen combinationFixed combination i. Macrolide antibiotics j. Systemic CS:Any regimenIntermittent regimenRegular regimen	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: Increase in the dose of one or both components;; Reduction in the dose of one or both components; b. Switch within the same drug class c. Switch between drug classes (dual-to-dual) d. Therapy escalation to triple combination; e. Therapy de-escalation to monotherapy	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: Increase in the dose of one or both components;; Reduction in the dose of one or both components; b. Switch within the same drug class c. Switch between drug classes (dual-to-dual) d. Therapy escalation to triple combination; e. Therapy de-escalation to monotherapy 5. Proportion of patients who have been receiving systemic CS for COPD exacerbation treatment during the follow-up period	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): <150 cells/μl;; 150-300 cells/μl;; ≥301 cells/μl.	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

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2025
• Primary Completion (Estimated): June 25, 2027
• Study Completion (Estimated): June 25, 2027

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: December 15, 2025
• First Posted (Actual): December 29, 2025

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: chronic obstructive pulmonary disease (COPD)
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: D2287R00217

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No