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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.

Official record
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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
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.

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

This Study is a multicenter, non-interventional, observational, ambispective (retrospective-prospective) study to evaluate clinical and demographic characteristics, approaches to therapy in outpatients with COPD and frequent exacerbations in the Russian Federation. Planned number of Study site is 35 outpatient centers with experience of treatment of COPD with frequency exacerbations in about 30 regions in Russia.

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.

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.

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. To describe the baseline mean smoking index .

    applicable for current/former tobacco smokers (pack-years)

    Measured: 52 weeks of retrospective data before visit 1

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. To describe proportion of patients with COPD-related disability present at the inclusion

    for each disability group (I, II, III)

    Measured: at visit 1

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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.

  1. First posted29 Oct 2025
  2. Study start16 Dec 2024
  3. Primary completion22 Jun 2026
  4. Study completion22 Jun 2026

Resources

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

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.

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