Gatchina

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 evaluating Raphamin in adults aged 18 to 64 years who have acute bronchitis symptoms lasting less than 72 hours. This randomized, double-blind, placebo-controlled phase 3 trial aims to determine if Raphamin can speed up symptom resolution, reduce disease severity, and prevent complications requiring antibiotics compared to placebo. The study includes both men and women during the seasonal period of acute respiratory viral infections. Participants are randomly assigned to receive either Raphamin or a placebo following a specific oral dosing schedule for 5 days. On the first day, participants take 8 tablets of Raphamin or placebo one tablet every 30 minutes for the first 2 hours total of 5 tablets, then one tablet three times spaced evenly throughout the day. From day 2 onwards, one tablet is taken three times daily. The study uses an electronic patient diary to record daily symptoms, and face-to-face visits are scheduled on days 1, 4, and 7, with a phone visit on day 14. Throughout the study, participants undergo physical exams, vital sign monitoring, pulse oximetry, and laboratory tests including blood counts and PCR for respiratory viruses. Symptom severity is assessed by the Bronchitis Severity Scale and the Integrative Medicine Outcome Scale. Quality of life is evaluated using the EQ-5D instrument. Safety is monitored through recording adverse events and any use of antibacterial medications or hospitalizations. The total duration of participation includes treatment and follow-up over 14 days.

Researchers are conducting a multicenter, double-blind, placebo-controlled, randomized clinical trial to study children aged 3 to 12 years with acute respiratory viral infection ARVI. This trial aims to evaluate the safety and effectiveness of Raphamin in treating ARVI symptoms during the seasonal incidence of the illness. Enrollment starts with children aged 6 to 12 years and may expand to include those aged 3 to 12 years based on interim safety and efficacy results. Participants will be randomly assigned to receive either Raphamin or a placebo. Raphamin is given orally as tablets that dissolve in the mouth, with a specific dosing schedule over five days eight tablets on the first day taken at intervals, then one tablet three times daily on days two through five. The placebo group follows the same dosing regimen using placebo tablets. The treatment period lasts five days, followed by monitoring and follow-up visits. During the study, parents or caregivers will record their childs symptoms and body temperature twice daily in an electronic diary, including any use of fever-reducing medications and changes in health. Children will have several visits with healthcare providers on days 1, 5, and 7, plus a phone visit on day 14 for safety and symptom assessment. Laboratory tests and physical exams will be conducted to monitor progress and safety. The primary outcome is the time until ARVI symptoms resolve within 14 days.

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.

The trial investigates the safety and effectiveness of olokizumab compared to a placebo in adults with progressive fibrosing interstitial lung diseases ILD. This phase 23 study uses a double-blind, parallel-group adaptive design to better understand treatment impacts on lung function over time. Participants have progressive fibrosing ILD confirmed by imaging and lung function tests, with disease progression documented within the prior months or years. Participants will be randomly assigned to receive either subcutaneous injections of olokizumab 64 mg or placebo every four weeks during a 48-week treatment period. The study includes a screening period lasting four weeks, followed by a treatment period of 48 weeks, and then a follow-up period of 24 weeks with visits scheduled at 4, 12, and 24 weeks post-treatment. The total duration of participation is approximately 76 weeks. Throughout the study, patients will undergo lung function tests including forced vital capacity FVC and diffusion capacity for carbon monoxide DLCO, as well as imaging assessments to evaluate lung fibrosis. Researchers will monitor symptoms, lung function changes, and quality of life measures using dyspnea scores and health questionnaires. Safety will be closely observed during treatment and follow-up visits, with the main outcome focused on changes in FVC over 48 weeks.

Researchers are evaluating the efficacy and safety of a liquid form of Rengalin for treating cough caused by acute viral upper respiratory tract infections in children aged 6 months to 3 years during the epidemic growth of influenza and ARVI. This randomized, double-blind, placebo-controlled trial compares Rengalin with a placebo to determine its effect on cough severity in young children. Participants will be randomly assigned to receive either 5 ml of Rengalin or a placebo orally three times a day for 7 days. The study includes initial screening and consent, followed by treatment and monitoring visits on days 1, 4, and 8, with a phone follow-up on day 14. On day 4, if needed, mucolytic ambroxol may be added while continuing the assigned study treatment. Parents will use an electronic diary to record cough severity twice daily throughout the study. During the study, researchers will assess symptoms, perform physical exams, and conduct laboratory tests including blood and urine analyses in at least half the participants. Safety and treatment adherence are closely monitored through visits and diaries. The main outcome is the percentage of patients responding to treatment by day 3, with secondary outcomes including changes in cough severity by day 7. The total study duration for participants is up to 14 days with ongoing observation.

Researchers are evaluating the safety, immune response, and effectiveness of a gene therapy called ANB-002 in adult males with Hemophilia B. This multicenter, open-label study uses a dose-escalation approach combining phase I and II elements to find the best dose of ANB-002, which carries the gene for clotting factor IX FIX. Participants are grouped into four cohorts receiving single intravenous infusions of ANB-002 at increasing doses. Cohorts 1 to 3 involve escalating doses with monitoring for dose-limiting toxicities over 28 days after each infusion. Cohort 4 includes patients with certain antibodies or past hepatitis B infection receiving the highest dose. Decisions to proceed with dosing or enrollment are made by an independent committee. The total participation lasts up to five years. Throughout the study, participants undergo regular assessments including measures of FIX activity, bleeding rates, quality of life questionnaires, and joint health evaluations. Safety monitoring includes tracking adverse reactions during and after treatment. The primary outcomes focus on changes in clotting factor activity and side effects over a five-year period, with secondary outcomes assessing bleeding frequency, treatment use, and well-being.

Researchers are evaluating the efficacy and safety of Raphamin in treating acute rhinosinusitis in adult patients aged 18 to 75 years. This multicenter, double-blind, placebo-controlled, randomized clinical trial focuses on adults experiencing symptoms within 48 hours of disease onset during the seasonal peak of acute respiratory viral infections. The study aims to compare Raphamin against placebo in improving symptoms and quality of life. Participants will be randomly assigned to one of two groups at the first visit. One group receives Raphamin tablets dissolved in the mouth following a specific dosing schedule over 5 days, starting with multiple doses on day 1 and three times daily thereafter. The other group receives a placebo on the same schedule. The study includes a treatment period of 5 days and follow-up visits up to 14 days. Participants will attend three visits on days 1, 4, and 7, either at a medical center or at home, with a phone visit on day 14. They will complete symptom severity scales and quality of life questionnaires, record daily temperature and symptoms in an electronic diary, and report any worsening condition or adverse events. Researchers will monitor symptom improvement, safety, antibiotic use, hospitalizations, and vital signs throughout the study and follow-up period.