Blagoveshchensk

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 clinical effectiveness and safety of combining best endovascular treatment with gene therapy using supercoiled plasmid pCMV-VEGF165 compared to best endovascular treatment alone for severe lower limb ischemia. This trial focuses on patients with critical ischemia categorized as Rutherford grades 4 and 5 and Fontaine grades III and IV. The goal is to see if adding gene therapy reduces the number of repeat interventions and high amputations, while increasing the time between any needed re-interventions, addressing a significant medical and economic challenge. The study is a multicenter, randomized, prospective, controlled Phase 4 trial. Participants will receive either the best endovascular treatment alone or combined with the gene therapy drug Neovasculgen, which stimulates new blood vessel growth in the affected limb. Treatments will be evaluated immediately and over the long term using clinical and instrumental methods to compare their effectiveness and safety. Participants will be monitored for two years after intervention to assess freedom from repeat procedures on the treated segment and freedom from high amputations. Follow-up includes clinical exams and instrumental assessments. The study tracks the number and timing of re-interventions and amputations to evaluate treatment outcomes and safety. Participants must comply with study procedures and attend follow-up visits during this period.