Study of Patient With Frequent Exacerbations in Moscow

NCT07307781 | Recruiting

• 1 other identifier: D2287R00217
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

chronic obstructive pulmonary disease (COPD)

Outcome Measures

Primary Outcomes (22)

• To describe the baseline mean age of outpatients with COPD in Moscow.

  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;

  52 weeks of retrospective data before visit 1

• To describe the baseline Demographic data characterisics of outpatients with COPD in Moscow.

  3\. Proportion of men and women; 4. Proportion of patients with different educational status at inclusion: 1. Higher education; 2. Secondary special education; 3. Secondary general education.

  52 weeks of retrospective data before visit 1

• To describe the baseline Negative lifestyle factors of outpatients with COPD in Moscow.

  5\. Proportion of patients with different negative lifestyle factors at inclusion (evaluated at Visit 1 based on patient interview): a. Proportion of patients with history of smoking (former smokers) and current smokers - applicable for both tobacco and e-cigarettes (vapes) smokers; d. Proportion of patient with physical inactivity. 7. Proportion of overweight patients

  52 weeks of retrospective data before visit 1

• To describe the baseline Anthropometry data characterisics of outpatients with COPD in Moscow.

  6\. Mean body mass index (BMI) (kg/m2) at inclusion (evaluated at Visit 1 or the most recent available value obtained within the previous 52 weeks if cannot be measured at Visit 1);

  52 weeks of retrospective data before visit 1

• To describe the baseline mean smoking index .

  5 b. applicable for former and current tobacco smokers;

  52 weeks of retrospective data before visit 1

• To describe the baseline mean duration of smoking

  5 c. applicable for former and current e cigarettes (vapes) smokers;

  52 weeks of retrospective data before visit 1

• To describe a COPD clinical course of outpatients with COPD in Moscow

  8\. Proportion of patients with different COPD severity based on GOLD classification at inclusion: 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;

  52 weeks of retrospective data before visit 1

• To describe a COPD exacerbation of outpatients with COPD in Moscow

  10\. Annualized rate of moderate COPD exacerbations prior to inclusion 13. Annualized rate of severe COPD exacerbations prior to inclusion

  52 weeks of retrospective data before visit 1

• To describe a severe COPD exacerbation of outpatients with COPD in Moscow

  14\. Cumulative days of severe COPD exacerbations prior to inclusion

  52 weeks of retrospective data before visit 1

• To describe a COPD drug therapy of outpatients with COPD in Moscow

  15\. Proportion of patients receiving different classes of drugs for treatment of COPD (both maintenance therapy and exacerbation management) and their combinations (administered either as separate agents or as fixed combination) prior to inclusion: 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.

  52 weeks of retrospective data before visit 1

• To describe a Spirometry parameters at baseline of outpatients with COPD in Moscow

  16\. Mean pre-bronchodilator FEV1 at inclusion (the most recent available value obtained within the previous 52 weeks outside of an exacerbation); 17. Mean post-bronchodilator FEV1 at inclusion (the most recent available value obtained within the previous 52 weeks outside of an exacerbation); 18. Mean FVC at inclusion (the most recent available value obtained within the previous 52 weeks outside of an exacerbation);

  52 weeks of retrospective data before visit 1

• To describe a FEV1 / FVC ratio at baseline of outpatients with COPD in Moscow

  19\. Mean post-bronchodilator FEV1 / FVC ratio at inclusion (the most recent available value obtained within the previous 52 weeks outside of an exacerbation).

  52 weeks of retrospective data before visit 1

• To describe Blood eosinophils count at baseline of outpatients with COPD in Moscow

  20\. Mean blood eosinophils count (cells/μl) at inclusion (the most recent available value obtained within the previous 52 weeks); 21. Proportion of patients with different levels of blood eosinophils count at inclusion (based on the most recent available value obtained within the previous 52 weeks): 1. \<150 cells/μl; 2. 150-300 cells/μl; 3. ≥301 cells/μl.

  52 weeks of retrospective data before visit 1

• To describe CAT questionnaire score at baseline of outpatients with COPD in Moscow

  22\. Mean COPD Assessment Test (CAT) score at inclusion (evaluated at Visit 1 or the most recent available value obtained within the previous 6 weeks if evaluation at Visit 1 is not possible).

  52 weeks of retrospective data before visit 1

• To describe Healthcare resource utilization of outpatients with COPD in Moscow

  23\. Proportion of patients with healthcare resource utilization events during 52 weeks prior to inclusion: 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

  52 weeks of retrospective data before visit 1

• To describe COPD comorbidities at baseline of outpatients with COPD in Moscow

  26\. Proportion of patients with different comorbidities at inclusion (diagnosed by study physician at Visit 1 or diagnosed at any time previously and recorded based on medical documentation or patient interview): 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;

  52 weeks of retrospective data before visit 1

• To describe COPD and Heart Failure comorbidity at baseline of outpatients with COPD in Moscow

  28\. Proportion of patients with each HF phenotype based on left ventricle ejection fraction (LVEF) at inclusion (to be calculated in the subgroup of patients with any HF before or at Visit 1): 1. HF with reduced ejection fraction (HFrEF); 2. HF with mid-range ejection fraction (HFmrEF); 3. HF with preserved ejection fraction (HFpEF);

  52 weeks of retrospective data before visit 1

• To describe LVEF at baseline of outpatients with COPD in Moscow

  29\. Mean and median LVEF (%) at inclusion (to be calculated in the subgroup of patients with any HF before or at Visit 1 and available data on LVEF based on echocardiography);

  52 weeks of retrospective data before visit 1

• To describe COPD and Chronic Kidney Disease comorbidity at baseline of outpatients with COPD in Moscow

  30\. Proportion of patients with each CKD stage based on estimated glomerular filtration rate (eGFR) at inclusion (to be calculated in the subgroup of patients with any CKD before or at Visit 1): 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);

  52 weeks of retrospective data before visit 1

• To describe COPD and Arterial Hypertension (AH) comorbidity at baseline of outpatients with COPD in Moscow

  31\. Proportion of patients with each AH degree at inclusion (to be evaluated in patients with AH diagnosed before or at Visit 1): 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;

  52 weeks of retrospective data before visit 1

• To describe blood pressure at baseline of outpatients with COPD in Moscow

  34\. Mean office systolic blood pressure (SBP) (mmHg) measured at inclusion (in total population and by presence of AH diagnosed before or at Visit 1); 35. Mean office diastolic blood pressure (DBP) (mmHg) measured at inclusion (in total population and by presence of AH diagnosed before or at Visit 1);

  at visit 1

• To describe a treatment of comorbidities at baseline of outpatients with COPD in Moscow

  36\. Proportion of patients receiving different classes of medications used for treatment of comorbidities (to be evaluated in the subgroup of patients with at least one comorbidity specified above in paragraph #26)

  at visit 1

Secondary Outcomes (19)

• To describe COPD drug therapy during the follow-up period and its change compared to the previous 52 weeks

  24 weeks after visit 1

• To describe corticosteroid therapy during the follow-up period of outpatients with COPD in Moscow

  24 weeks after visit 1

• To describe changes of inhaled COPD therapy during the follow-up period of outpatients with COPD in Moscow

  24 weeks after visit 1

• To describe COPD therapy during the follow-up period of outpatients with COPD in Moscow

  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

  24 weeks after visit 1

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

study population consists of 500 adult patients with moderate-to-very severe COPD who have experienced ≥2 moderate or ≥1 severe exacerbations within the previous 52 weeks and received dual inhaled maintenance therapy (LABA/LAMA, ICS/LAMA, or ICS/LABA combinations, but not triple ICS/LAMA/LABA therapy) for at least 6 weeks prior to screening

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Moscow, Russia

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 29, 2025
• Study Start: November 28, 2025
• Primary Completion (Estimated): June 25, 2027
• Study Completion (Estimated): June 25, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

RU (1)