Study of Patient With Frequent COPD Exacerbations

NCT07221981 | Active Not Recruiting

• 1 other identifier: D5980R00123
• Study Type: observational
• Target: 1,708
• Locations: 1 country
• Sites: 6

Brief 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. Planned number of Study site is 35 outpatient centers with experience of treatment of COPD with frequency exacerbations in about 30 regions in Russia.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

chronic obstructive pulmonary disease (COPD)

Outcome Measures

Primary Outcomes (17)

• 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;

  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): 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.

  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);

  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.

  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

  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);

  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).

  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.

  52 weeks of retrospective data before visit 1

• To describe the baseline mean smoking index .

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

  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);

  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

  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: a) dosage Macrolide antibiotics b) dosage CS

  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.

  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);

  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.

  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);

  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.

  14\. to be calculated in patients with presence of CKD before or on Visit 1.

  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.

  15\. this parameter evaluated in total population and in patients with presence of AH before or on Visit 1)

  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.

  16\. to be evaluated in patients with presence of AH before or on Visit 1;

  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.

  17\. to be evaluated in patients with at least one cardiovascular disease

  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

  24 weeks after visit 1

• To describe Healthcare resource utilization during 24-week prospective study follow-up compared to baseline period

  24 weeks after visit 1

• To describe changes of Mean forced expiratory volume during 24-week prospective study follow-up compared to baseline

  24 weeks after visit 1

• To describe Change in CAT score during 24-week prospective study follow-up compared to baseline

  24 weeks after visit 1

• To describe Newly occurred cardiovascular diseases and other comorbidities during 24-week prospective study follow-up

  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

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

You may qualify if:

• Patients with diagnosed moderate-to-severe COPD (see comments below);
• ≥2 moderate or ≥1 severe COPD exacerbations in previous 52 weeks (see comments below);

You may not qualify if:

• 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;

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (6)

Research site

Ivanovo, Russia

Location

Research site

Moscow, Russia

Location

Research site "OOO Energy of health"

Saint Petersburg, Russia

Location

Research site

Saint Petersburg, Russia

Location

Research site

Voronezh, Russia

Location

Research site

Yekaterinburg, Russia

Location

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

Study Design

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

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: October 29, 2025
• Study Start: December 16, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 2, 2026

Record last verified: 2026-05

Locations

RU (6)