Chronic Obstructive Pulmonary Disease (COPD)PRIORITY-COPDNCT07221981

Study of Patient With Frequent COPD Exacerbations

An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 30 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. 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: 2,024 participants
Where: 30 sitesRussia
Study dates: 16 Dec 2024to 22 Jun 2026
Phase: Observational
Are there results?: None posted in the registry

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: 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

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;
Patients with diagnosed moderate-to-severe COPD (see comments below);
≥2 moderate or ≥1 severe COPD exacerbations in previous 52 weeks (see comments below);
Patients have been receiving two inhaled maintenance therapies (LABA/LAMA, ICS/LABA, ICS/LAMA) for at least 6 weeks prior to inclusion.

Who cannot join

Current or previous treatment with triple combination (ICS/LABA/LAMA) within 52 weeks prior to inclusion;
COPD due to documented α-1 antitrypsin deficiency;
A diagnosis of bronchiectasis, sarcoidosis, interstitial lung diseases, or idiopathic pulmonary fibrosis, exacerbation of bronchial 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 clinical study currently or within 52 weeks prior to inclusion.

Trial locations and contacts

30 sites in 1 country.

City, postcode or hospital

30 sites in 1 country

Russia30 sites

Research Site
Barnaul
Research Site
Chelyabinsk
Research Site
Ivanovo
Research Site
Izhevsk
Research Site
Kazan'
Research Site
Kemerovo
Research Site
Krasnodar
Research Site
Krasnoyarsk
Research Site
Moscow
Research Site
Nizhny Novgorod
Research Site
Novokuznetsk
Research Site
Novosibirsk
Research Site
Omsk
Research Site
Orenburg
Research Site
Perm
Research Site
Petrozavodsk
Research Site
Rostov-on-Don
Research Site
Ryazan
Research Site
Saint Petersburg
Research Site
Samara
Research Site
Stavropol
Research Site
Tomsk
Research Site
Tyumen
Research Site
Ufa
Research Site
Ulan-Ude
Research Site
Vladivostok
Research Site
Volgograd
Research Site
Voronezh
Research Site
Yakutsk
Research Site
Yekaterinburg

Other trials in Russia

About this study

Official title: Clinical and dEmographic chaRacteristics of Patients With Frequent COPD Exacerbations and Evaluation of Therapeutic Approaches in Treatment in RussiA

Read the detailed description

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.

Conditions: Chronic Obstructive Pulmonary Disease (COPD)
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 Demographic data characterisics of outpatients with moderate and severe COPD.
Demographic data
1. Mean age at the inclusion into the study, and age groups (<50; 50-65, >65 years);
2. Mean age at the primary COPD diagnosis;
3. Proportion of men and women;
4. Proportion of patients with each educational status (higher, secondary special, secondary general) at inclusion;
5. Proportion of patients from each residential region of Russia;
Measured: 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):
1. 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.
Measured: 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);
Measured: 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.
1. 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):
2. SABA alone;
3. ICS alone
4. LABA alone
5. LAMA alone
6. LABA and LAMA
7. ICS and LABA
8. ICS and LAMA
9. LABA and LAMA plus:
10. Macrolide antibiotics b) CS
Measured: 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);
Measured: 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).
Measured: 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):
1. <150 cells/μl;
2. ≥150 cells/μl;
3. ≥300 cells/μl.
Measured: 52 weeks of retrospective data before visit 1
To describe the baseline mean smoking index .
applicable for current/former tobacco smokers (pack-years)
Measured: 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);
Measured: 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
Measured: 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):
1. dosage SABA alone ;
2. dosage ICS alone
3. dosage LABA alone
4. dosage LAMA alone
5. dosage LABA and LAMA
6. dosage ICS and LABA
7. dosage ICS and LAMA
8. LABA and LAMA plus:
9. dosage Macrolide antibiotics b) dosage CS
Measured: 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.
1. 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);
Measured: 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.
1. 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);
Measured: 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.
1. to be calculated in patients with presence of CKD before or on Visit 1.
Measured: 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.
1. this parameter evaluated in total population and in patients with presence of AH before or on Visit 1)
Measured: 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.
1. to be evaluated in patients with presence of AH before or on Visit 1;
Measured: 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.
1. to be evaluated in patients with at least one cardiovascular disease
Measured: 52 weeks of retrospective data before visit 1

Secondary outcomes (28)

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):
1. SABA alone
2. LABA alone
3. LAMA alone
4. ICS alone
5. ICS and LABA
6. ICS and LAMA
7. LABA and LAMA
8. ICS and LABA and LAMA (triple therapy)
Measured: 24 weeks after visit 1
To describe Healthcare resource utilization during 24-week prospective study follow-up compared to baseline period
1. Proportion of patients with healthcare resource utilization events due to COPD during 52 weeks prior to inclusion (Visit 1):
- Unscheduled outpatient visits;
- Emergency department visits/emergency calls;
- Hospitalizations. 8. Proportion of patients with healthcare resource utilization events due to COPD occurred from inclusion (Visit 1) to Visit 2:
- Unscheduled outpatient visits;
- Emergency department visits/emergency calls;
- Hospitalizations.
Measured: 24 weeks after visit 1
To describe changes of Mean forced expiratory volume during 24-week prospective study follow-up compared to baseline
1. Mean parameters of lung function at inclusion (Visit 1) and Visit 2:
2. Mean forced expiratory volume in 1 second (pre- and post-FEV1); 12. change from baseline (Visit 1) to Visit 2:
3. Pre- and post-bronchodilator FEV1;
Measured: 24 weeks after visit 1
To describe Change in CAT score during 24-week prospective study follow-up compared to baseline
1. 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;
Measured: 24 weeks after visit 1
To describe Newly occurred cardiovascular diseases and other comorbidities during 24-week prospective study follow-up
1. 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.
Measured: 24 weeks after visit 1
To describe Blood eosinophils count during 24-week prospective study follow-up compared to baseline
1. Mean blood eosinophils count (cells/μl) on Visit 2; 19. Proportion of patients with different levels of blood eosinophils count on Visit 2:
2. <150 cells/μl;
3. ≥150 cells/μl;
4. ≥300 cells/μl. 20. Mean change in blood eosinophils count (cells/μl) from baseline (Visit 1) to Visit 2.
Measured: 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);
Measured: 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.
Measured: 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);
Measured: 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
Measured: 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.
Measured: 24 weeks after visit 1
To describe changes of Mean forced vital capacity during 24-week prospective study follow-up compared to baseline
- Mean forced vital capacity (FVC) at Visit 1
- Mean FVC change from baseline (Visit 1) to Visit 2
Measured: 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
- at Visit 1
- change from baseline (Visit 1) to Visit 2
Measured: 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;
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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
Measured: 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
Measured: 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;
Measured: 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;
Measured: 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;
Measured: 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;
Measured: 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;
Measured: 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;
Measured: 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;
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.

16 Dec 202422 Jun 2026

First posted29 Oct 2025
Study start16 Dec 2024
Primary completion22 Jun 2026
Study completion22 Jun 2026

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: 2,024 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07221981
Sponsor's protocol ID: D5980R00123
Acronym: PRIORITY-COPD
Status last verified: Oct 2026
First submitted: 13 May 2025
Last updated: 15 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 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 RussiA
ClinicalTrials.gov ID: NCT07221981
Acronym / sponsor ID: PRIORITY-COPD / D5980R00123
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: chronic obstructive pulmonary disease (COPD)
Study type: Observational
Recruitment status: Completed
Enrolment: 2,024 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 16 Dec 2024 (actual)
Primary completion: 22 Jun 2026 (actual)
Study completion: 22 Jun 2026 (actual)
First posted: 29 Oct 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.

Detailed description

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: 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

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;
Patients with diagnosed moderate-to-severe COPD (see comments below);
≥2 moderate or ≥1 severe COPD exacerbations in previous 52 weeks (see comments below);
Patients have been receiving two inhaled maintenance therapies (LABA/LAMA, ICS/LABA, ICS/LAMA) for at least 6 weeks prior to inclusion.

Key exclusion criteria (4 listed)

Current or previous treatment with triple combination (ICS/LABA/LAMA) within 52 weeks prior to inclusion;
COPD due to documented α-1 antitrypsin deficiency;
A diagnosis of bronchiectasis, sarcoidosis, interstitial lung diseases, or idiopathic pulmonary fibrosis, exacerbation of bronchial 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 clinical study currently or within 52 weeks prior to inclusion.

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 Demographic data characterisics of outpatients with moderate and severe COPD.
Time frame: 52 weeks of retrospective data before visit 1
Demographic data 1. Mean age at the inclusion into the study, and age groups (<50; 50-65, >65 years); 2. Mean age at the primary COPD diagnosis; 3. Proportion of men and women; 4. Proportion of patients with each educational status (higher, secondary special, secondary general) at inclusion; 5. Proportion of patients from each residential region of Russia;
To describe the baseline Negative lifestyle factors characterisics of outpatients with moderate and severe COPD.
Time frame: 52 weeks of retrospective data before visit 1
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.
To describe the baseline Anthropometry data characterisics of outpatients with moderate and severe COPD.
Time frame: 52 weeks of retrospective data before visit 1
Anthropometry data 7. Mean body mass index (BMI) at inclusion (in previous 52 weeks (the most recent available value) or evaluated on Visit 1);
To describe the baseline COPD drug treatment duration in previous 52 weeks of outpatients with moderate and severe COPD.
Time frame: 52 weeks of retrospective data before visit 1
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): 1. SABA alone; 2. ICS alone 3. LABA alone 4. LAMA alone 5. LABA and LAMA 6. ICS and LABA 7. ICS and LAMA 8. LABA and LAMA plus: a) Macrolide antibiotics b) CS
To describe the baseline Cardiovascular diseases of outpatients with moderate and severe COPD.
Time frame: 52 weeks of retrospective data before visit 1
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);
To describe the baseline other comorbidities of outpatients with moderate and severe COPD.
Time frame: 52 weeks of retrospective data before visit 1
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).
To describe the baseline Blood eosinophils count of outpatients with moderate and severe COPD.
Time frame: 52 weeks of retrospective data before visit 1
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): 1. <150 cells/μl; 2. ≥150 cells/μl; 3. ≥300 cells/μl.
To describe the baseline mean smoking index .
Time frame: 52 weeks of retrospective data before visit 1
applicable for current/former tobacco smokers (pack-years)
To describe the baseline mean duration of smoking
Time frame: 52 weeks of retrospective data before visit 1
applicable for current/former e-cigarettes (vapes) smokers (years);
To describe the Proportion of patients with overweight
Time frame: 52 weeks of retrospective data before visit 1
determined as BMI ≥25 kg/m2 at inclusion (in previous 52 weeks (the most recent available value) or evaluated on Visit 1
To describe the baseline dosages of COPD drug treatment in previous 52 weeks of outpatients with moderate and severe COPD.
Time frame: 52 weeks of retrospective data before visit 1
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): 1. dosage SABA alone ; 2. dosage ICS alone 3. dosage LABA alone 4. dosage LAMA alone 5. dosage LABA and LAMA 6. dosage ICS and LABA 7. dosage ICS and LAMA 8. LABA and LAMA plus: a) dosage Macrolide antibiotics b) dosage CS
To describe the baseline proportion of patients with heart failure of outpatients with moderate and severe COPD.
Time frame: 52 weeks of retrospective data before visit 1
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);
To describe the baseline data of LVEF of patients with heart failure of outpatients with moderate and severe COPD.
Time frame: 52 weeks of retrospective data before visit 1
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);
To describe the baseline proportion of patients with each CKD stage - C1, C2, C3a, C3b, C4, C5 of outpatients with moderate and severe COPD.
Time frame: 52 weeks of retrospective data before visit 1
14. to be calculated in patients with presence of CKD before or on Visit 1.
To describe the baseline mean office BP (SBP and DBP) measured at Visit 1 of outpatients with moderate and severe COPD.
Time frame: 52 weeks of retrospective data before visit 1
15. this parameter evaluated in total population and in patients with presence of AH before or on 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.
Time frame: 52 weeks of retrospective data before visit 1
16. to be evaluated in patients with presence of AH before or on 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.
Time frame: 52 weeks of retrospective data before visit 1
17. to be evaluated in patients with at least one cardiovascular disease

28 secondary outcomes

To describe the proportion of patients receiving different classes of drugs for treatment of COPD between V1 and V2
Time frame: 24 weeks after visit 1
To describe Healthcare resource utilization during 24-week prospective study follow-up compared to baseline period
Time frame: 24 weeks after visit 1
To describe changes of Mean forced expiratory volume during 24-week prospective study follow-up compared to baseline
Time frame: 24 weeks after visit 1
To describe Change in CAT score during 24-week prospective study follow-up compared to baseline
Time frame: 24 weeks after visit 1
To describe Newly occurred cardiovascular diseases and other comorbidities during 24-week prospective study follow-up
Time frame: 24 weeks after visit 1
To describe Blood eosinophils count during 24-week prospective study follow-up compared to baseline
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 24 weeks after visit 1
To describe Mean duration of COPD-related hospitalizations during 52 weeks prior to inclusion
Time frame: 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
Time frame: 24 weeks after visit 1
To describe changes of Mean forced vital capacity during 24-week prospective study follow-up compared to baseline
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 24 weeks after visit 1
To describe Proportion of patients with CS using for COPD exacerbations treatment during the study
Time frame: 24 weeks after visit 1
To describe proportion of patients with COPD-related disability present at the inclusion
Time frame: at visit 1
To describe proportion of patients with COPD-related disability changing during study follow-up
Time frame: 24 weeks after visit 1
To describe proportion of patients with COPD-related disability newly established during study follow-up
Time frame: 24 weeks after visit 1
To describe proportion of patients with atrial fibrillation/flutter, ventricular arrhythmias, other arrhythmia
Time frame: 24 weeks after visit 1
To describe proportion of patients with each heart failure phenotype based on LVEF - HFrEF, HFmrEF, HFpEF
Time frame: 24 weeks after visit 1
To describe Mean and median value of LVEF, %
Time frame: 24 weeks after visit 1
To describe proportion of patients with decompensation of previously diagnosed heart failure
Time frame: 24 weeks after visit 1
To describe proportion of patients with each CKD stage - C1, C2, C3a, C3b, C4, C5
Time frame: 24 weeks after visit 1
To describe proportion of patients with each type of stroke occurred during the study follow-up - ischemic, hemorrhagic
Time frame: 24 weeks after visit 1
To describe mean office BP (SBP and DBP) measured at Visit 2
Time frame: 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
Time frame: 24 weeks after visit 1
To describe proportion of patients with various classes of medications used for treatment of CVD
Time frame: 24 weeks after visit 1

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

30 sites 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 30 sites 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: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To describe the baseline Demographic data characterisics of outpatients with moderate and severe COPD. (time frame: 52 weeks of retrospective data before visit 1). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07221981.

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 15 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.