Chronic Obstructive Pulmonary Disease (COPD)CERERA-MOSCOWNCT07307781
Study of Patient With Frequent Exacerbations in Moscow
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 1 site in Russia.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- How many people
- 300 participants
- Where
- 1 siteRussia
- Study dates
- 28 Nov 2025to 25 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
About this study
Official title: 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
Read the 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.
- Keywords
- chronic obstructive pulmonary disease (COPD)
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: 52 weeks of retrospective data before visit 1
To describe the baseline Demographic data characterisics of outpatients with COPD in Moscow.
- Proportion of men and women; 4. Proportion of patients with different educational status at inclusion:
- Higher education;
- Secondary special education;
- Secondary general education.
Measured: 52 weeks of retrospective data before visit 1
To describe the baseline Negative lifestyle factors of outpatients with COPD in Moscow.
- Proportion of patients with different negative lifestyle factors at inclusion (evaluated at Visit 1 based on patient interview):
- 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
Measured: 52 weeks of retrospective data before visit 1
To describe the baseline Anthropometry data characterisics of outpatients with COPD in Moscow.
- 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);
Measured: 52 weeks of retrospective data before visit 1
To describe the baseline mean smoking index .
5 b. applicable for former and current tobacco smokers;
Measured: 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;
Measured: 52 weeks of retrospective data before visit 1
To describe a COPD clinical course of outpatients with COPD in Moscow
- 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:
- 0 severe COPD exacerbations; b. 1 severe COPD exacerbation; c. 2 severe COPD exacerbations; d. ≥3 severe COPD exacerbations;
Measured: 52 weeks of retrospective data before visit 1
To describe a COPD exacerbation of outpatients with COPD in Moscow
- Annualized rate of moderate COPD exacerbations prior to inclusion 13. Annualized rate of severe COPD exacerbations prior to inclusion
Measured: 52 weeks of retrospective data before visit 1
To describe a severe COPD exacerbation of outpatients with COPD in Moscow
- Cumulative days of severe COPD exacerbations prior to inclusion
Measured: 52 weeks of retrospective data before visit 1
To describe a COPD drug therapy of outpatients with COPD in Moscow
- 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:
- Macrolide antibiotics; b) Systemic corticosteroids.
Measured: 52 weeks of retrospective data before visit 1
To describe a Spirometry parameters at baseline of outpatients with COPD in Moscow
- 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);
Measured: 52 weeks of retrospective data before visit 1
To describe a FEV1 / FVC ratio at baseline of outpatients with COPD in Moscow
- Mean post-bronchodilator FEV1 / FVC ratio at inclusion (the most recent available value obtained within the previous 52 weeks outside of an exacerbation).
Measured: 52 weeks of retrospective data before visit 1
To describe Blood eosinophils count at baseline of outpatients with COPD in Moscow
- 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.
Measured: 52 weeks of retrospective data before visit 1
To describe CAT questionnaire score at baseline of outpatients with COPD in Moscow
- 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).
Measured: 52 weeks of retrospective data before visit 1
To describe Healthcare resource utilization of outpatients with COPD in Moscow
- 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:
- 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
Measured: 52 weeks of retrospective data before visit 1
To describe COPD comorbidities at baseline of outpatients with COPD in Moscow
- 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):
- Atrial fibrillation / atrial flutter; b. Ventricular arrhythmia; c. Another arrhythmia;
Measured: 52 weeks of retrospective data before visit 1
To describe COPD and Heart Failure comorbidity at baseline of outpatients with COPD in Moscow
- 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);
Measured: 52 weeks of retrospective data before visit 1
To describe LVEF at baseline of outpatients with COPD in Moscow
- 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);
Measured: 52 weeks of retrospective data before visit 1
To describe COPD and Chronic Kidney Disease comorbidity at baseline of outpatients with COPD in Moscow
- 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);
Measured: 52 weeks of retrospective data before visit 1
To describe COPD and Arterial Hypertension (AH) comorbidity at baseline of outpatients with COPD in Moscow
- 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):
- 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;
Measured: 52 weeks of retrospective data before visit 1
To describe blood pressure at baseline of outpatients with COPD in Moscow
- 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);
Measured: at visit 1
To describe a treatment of comorbidities at baseline of outpatients with COPD in Moscow
- 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)
Measured: at visit 1
Secondary outcomes (19)
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 alone
- ICS alone
- LABA alone
- LAMA alone
- LABA/LAMA;
- ICS/LABA
- ICS/LAMA
- LABA/LAMA/ICS <!-- -->
- Any combination
- Open combination
- Fixed combination i. Macrolide antibiotics j. Systemic CS: <!-- -->
- Any regimen
- Intermittent regimen
- Regular regimen
Measured: 24 weeks after visit 1
To describe corticosteroid therapy during the follow-up period of outpatients with COPD in Moscow
- 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);
Measured: 24 weeks after visit 1
To describe changes of inhaled COPD therapy during the follow-up period of outpatients with COPD in Moscow
- 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:
- 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
Measured: 24 weeks after visit 1
To describe COPD therapy during the follow-up period of outpatients with COPD in Moscow
- 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:
- 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
Measured: 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
- 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
Measured: 24 weeks after visit 1
To describe exacerbations of outpatients with COPD in Moscow
- 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
Measured: 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
- 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;
Measured: 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
- 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
Measured: 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
- 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;
Measured: 24 weeks after visit 1
To describe Proportion of patients with different levels of blood eosinophils count of outpatients with COPD in Moscow
- 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.
Measured: 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
- 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
Measured: 24 weeks after visit 1
To describe Proportion of responders based on CAT score of outpatients with COPD in Moscow
- 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.
Measured: 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
- 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)
Measured: 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
- Mean duration of COPD-related hospitalizations (days) during the follow-up period
Measured: 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
- 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
Measured: 24 weeks after visit 1
To describe disability during follow-up period of outpatients with COPD in Moscow
- 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)
Measured: 24 weeks after visit 1
To describe LVEF during follow-up period of outpatients with COPD in Moscow
- 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);
Measured: 24 weeks after visit 1
To describe blood pressure during follow-up period of outpatients with COPD in Moscow
- 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);
Measured: 24 weeks after visit 1
To describe adverse drug reactions during follow-up period of outpatients with COPD in Moscow
- 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.
Measured: 24 weeks after visit 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start28 Nov 2025
- Primary completion25 Jun 2027 (estimated)
- Study completion25 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07307781
- Sponsor's protocol ID
- D2287R00217
- Acronym
- CERERA-MOSCOW
- Status last verified
- Sep 2026
- First submitted
- 15 Dec 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and dEmographic chaRacteristics of Patients With Frequent COPD Exacerbations and Evaluation of Therapeutic Approaches in Treatment in Moscow
- ClinicalTrials.gov ID
- NCT07307781
- Acronym / sponsor ID
- CERERA-MOSCOW / D2287R00217
- Keywords
- chronic obstructive pulmonary disease (COPD)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2025 (actual)
- Primary completion
- 25 Jun 2027 (estimated)
- Study completion
- 25 Jun 2027 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To describe the baseline mean age of outpatients with COPD in Moscow.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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 .
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
19 secondary outcomes
To describe COPD drug therapy during the follow-up period and its change compared to the previous 52 weeks
Time frame: 24 weeks after visit 1
To describe corticosteroid therapy during the follow-up period of outpatients with COPD in Moscow
Time frame: 24 weeks after visit 1
To describe changes of inhaled COPD therapy during the follow-up period of outpatients with COPD in Moscow
Time frame: 24 weeks after visit 1
To describe COPD therapy during the follow-up period of outpatients with COPD in Moscow
Time frame: 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
Time frame: 24 weeks after visit 1
To describe exacerbations of outpatients with COPD in Moscow
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 24 weeks after visit 1
To describe Proportion of patients with different levels of blood eosinophils count of outpatients with COPD in Moscow
Time frame: 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
Time frame: 24 weeks after visit 1
To describe Proportion of responders based on CAT score of outpatients with COPD in Moscow
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 24 weeks after visit 1
To describe disability during follow-up period of outpatients with COPD in Moscow
Time frame: 24 weeks after visit 1
To describe LVEF during follow-up period of outpatients with COPD in Moscow
Time frame: 24 weeks after visit 1
To describe blood pressure during follow-up period of outpatients with COPD in Moscow
Time frame: 24 weeks after visit 1
To describe adverse drug reactions during follow-up period of outpatients with COPD in Moscow
Time frame: 24 weeks after visit 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To describe the baseline mean age of outpatients with COPD in Moscow. (time frame: 52 weeks of retrospective data before visit 1). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.