Blagoveshchensk

Researchers are conducting an observational multicenter cross-sectional study involving 5,000 adult patients in Russia with uncontrolled severe asthma SA who are receiving standard care treatments except biologics. The study aims to describe the characteristics of these patients across about 50 outpatient centers in 50 regions of Russia, addressing the lack of unified data on severe asthma epidemiology, complications, comorbidities, and treatment patterns in the country. Participants will have a single study visit where demographic and clinical data will be collected without any additional interventions or changes to their routine care. The study will gather information on treatment patterns, including the use of oral corticosteroids and various medication classes, and analyze clinical and demographic features such as age at diagnosis, gender distribution, body mass index, lifestyle factors, and presence of comorbidities. During the study, researchers will review medical records and follow-up data from the prior 52 weeks to assess treatment changes, exacerbations, healthcare resource use, and lung function parameters. No extra diagnostic or therapeutic procedures will be performed beyond standard practice. The study will run from June 2024 to June 2027, aiming to provide detailed epidemiological insights into uncontrolled severe asthma in the Russian adult population.

Researchers are studying uncontrolled asthma in adults across Russia to better understand its characteristics and treatment patterns. This large-scale observational registry will include 9,000 patients from 70 outpatient centers in about 50 regions, focusing on those not receiving biologic therapy. The study aims to describe demographic and clinical features, capture complications and comorbidities, and evaluate routine therapies used in real practice. The study has an ambispective design with two main visits. At the first visit, physicians will collect baseline data from the past 52 weeks using medical records and patient interviews. The second visit, conducted 12 weeks later, will gather follow-up information on treatment changes and clinical outcomes. A subgroup of 500 patients using fixed-dose combination budesonidesalbutamol will have an additional third visit 12 weeks after the second to collect further data. Participants will undergo routine clinical assessments during 2 to 3 visits following standard practice. Researchers will examine demographic and clinical data, blood and sputum eosinophil counts, total IgE levels, asthma control status, lung function tests, exacerbation rates, and healthcare resource use. Safety monitoring aligns with routine care, and the study does not involve any experimental treatments or procedures. Total participation spans approximately 24 weeks for those in the extended follow-up group.

Researchers are investigating the combined use of best endovascular treatment and gene therapy for people with severe lower limb ischemia, specifically those classified under Rutherford categories 4 and 5 and Fontaine grades III and IV. This trial aims to compare this combination approach to standard endovascular treatment alone, hypothesizing that adding gene therapy may reduce repeat interventions and high amputations, and increase the time between needed treatments. The study addresses a critical medical need as current treatments often require multiple interventions and have high rates of major amputations, which lead to disability and increased mortality. The study has two groups one receiving the standard best endovascular treatment, which includes arterial stenting or balloon angioplasty, and the other group receiving this same treatment plus gene therapy with Neovasculgen. Neovasculgen is a drug containing a supercoiled plasmid DNA that stimulates new blood vessel growth. This gene therapy is given by intramuscular injection in two doses, on days 7 and 21 after the endovascular procedure. The trial is randomized and controlled, with patients assigned to either treatment group. Participants will be monitored over two years to assess outcomes such as freedom from repeated interventions and high amputations, pain levels, ulcer healing, walking distance, and overall survival. The study includes regular clinical and instrumental assessments, including hemodynamic measurements and safety monitoring for serious adverse events. The research team will also track major adverse limb and cardiovascular events during this period. Participants will need to attend follow-up visits and comply with study instructions throughout the study duration.