Vladimir

Researchers are conducting an observational multicenter cross-sectional study to better understand the characteristics of adults with uncontrolled severe asthma in Russia who are not receiving biological therapy. The study aims to collect detailed information on the epidemiology, clinical features, treatment patterns, and demographics of these patients across different regions of the Russian Federation, which vary widely in population composition and environmental factors. The study will help fill the gap in data about severe asthma in Russia, especially in patients treated according to standard care but excluding biologics. The study plans to include 5,000 adult patients from about 50 outpatient centers across 50 regions of Russia. It will collect routine clinical data without altering standard medical care or introducing any new diagnostic or therapeutic procedures. The study design includes one visit per patient to gather demographic, clinical, and treatment information, focusing on patients with uncontrolled severe asthma receiving standard treatments like inhaled corticosteroids with other medications but not biological agents. Participants will provide data through medical records and assessments such as the Asthma Control Questionnaire. Researchers will analyze patterns of drug use, clinical characteristics including comorbidities, blood counts, immunoglobulin levels, and lifestyle factors. The study will characterize patients' demographics, treatment trends, and asthma control status from June 2024 to June 2027. Safety monitoring is observational, with no intervention beyond routine care, and the total participation involves a single study visit.

Researchers are conducting a large, non-interventional observational study to better understand adults with uncontrolled asthma across Russia. This study aims to gather detailed information on the demographic and clinical characteristics of these patients, the treatments they receive, and how their condition is managed in routine clinical practice. The study focuses on patients not treated with biologics and covers a diverse population from about 50 regions in Russia, reflecting differences in ethnicity, climate, and economic status. The study will include 9,000 adult patients with uncontrolled mild to moderate asthma who are receiving standard care. Data will be collected during 2-3 visits that follow routine clinical practice schedules. At the first visit, information from the previous 52 weeks will be gathered from medical records and patient interviews. The second visit will take place about 12 weeks later to collect follow-up data on treatment changes and clinical outcomes. For a subgroup of 500 patients using a fixed-dose combination of budesonide/salbutamol at the second visit, an additional third visit will occur 12 weeks later to further monitor treatment and outcomes. Participants will be monitored through medical record reviews and interviews during these visits. Researchers will assess baseline characteristics such as blood eosinophil counts, sputum eosinophils, and total IgE levels, along with treatment profiles and clinical outcomes. The study does not involve any experimental interventions beyond standard care and aims to provide comprehensive real-world data on uncontrolled asthma management in Russia. The total study duration for participants includes up to 24 weeks of follow-up for some patients.

Researchers are evaluating the effectiveness and safety of olokizumab (OKZ) compared to a placebo in patients with progressive fibrosing interstitial lung diseases (ILD). This phase 2/3 study uses a double-blind, parallel-group, adaptive design to assess treatment impact on lung function. Progressive fibrosing ILD is confirmed by imaging and lung function tests, with disease progression criteria including declines in lung capacity and worsening symptoms. Participants will receive subcutaneous injections of either 64 mg olokizumab or placebo every 4 weeks during a 48-week double-blind treatment period. The study begins with a 4-week screening period before treatment starts. After completing treatment, all participants enter a 24-week follow-up phase with visits at weeks 52, 60, and 72 to monitor ongoing effects and safety. Throughout the study, patients will undergo lung function tests, imaging reviews, and assessments of respiratory symptoms. Researchers will measure changes in forced vital capacity (FVC) over 48 weeks as the primary outcome. Safety and adverse events will be monitored during treatment and follow-up. The total participation time is about 76 weeks, including screening, treatment, and follow-up periods.

Researchers are studying how Lipoprotein(a) (Lp(a)) levels are distributed among patients in Russia with Atherosclerotic Cardiovascular Disease (ASCVD) and examining the link between high Lp(a) levels and the risk of cardiovascular disease. The study includes patients with a history of heart attacks, strokes, or other vascular conditions to better understand this relationship. The study has several phases. Phase I involves a cross-sectional study measuring Lp(a) levels in ASCVD patients. Phase II includes a non-interventional, prospective cohort study following the same patients, along with cross-sectional and cohort studies involving their relatives. Various drugs including statins (Atorvastatin, Simvastatin, Rozuvastatin), Ezetimibe, Niacin, fibrates (Ciprofibrate, Fenofibrate, Bezafibrate), PCSK9 inhibitors (Evolocumab, Alirocumab), and small interfering RNA (Inclisiran) are monitored as part of the research. Participants will undergo assessments of their Lp(a) levels and cardiovascular events over 24 months. Researchers will track the percentage of patients with Lp(a) levels above a specific threshold and compare cardiovascular event rates between groups. The study also involves collecting medical history and monitoring safety. The total participation duration includes initial screening and follow-up periods as outlined in the study phases.