Gatchina

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 multicenter, double-blind, placebo-controlled, randomized clinical trial to study children aged 3 to 12 years with acute respiratory viral infection (ARVI) symptoms within 24 hours of onset. The trial aims to evaluate the efficacy and safety of Raphamin compared to a placebo in treating ARVI. Enrollment will begin with children aged 6 to 12 years, followed by an interim analysis to decide whether to include younger children aged 3 to 5 years. Patients will be outpatients of either gender during seasonal ARVI incidence. Participants will be randomly assigned to receive either Raphamin tablets or placebo tablets for 5 days. Treatment groups follow the same dosage regimen. Before starting therapy, nasopharyngeal swabs will confirm viral infection through PCR testing. Throughout the trial, an electronic patient diary will be used to record temperature, symptoms, antipyretic use, and any worsening condition. The study includes screening, randomization, treatment, and follow-up periods lasting a total of 14 days. During the study, patients will attend three visits on days 1, 5, and 7, either at a health center or home, plus a phone visit on day 14. At visits, physicians will assess symptom severity, perform examinations, monitor diary completion, and conduct lab tests. The main outcome measured is the time needed for ARVI symptoms to resolve within 14 days. Safety and compliance will be closely monitored, and symptomatic or concomitant therapies are allowed except for prohibited drugs.

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 evaluating the efficacy and safety of a liquid form of Rengalin for treating cough in children aged 6 months to 3 years who have acute viral upper respiratory infections during flu and ARVI outbreaks. This Phase 3 clinical trial compares Rengalin with a placebo to see if it effectively reduces cough severity in young children with dry or non-productive cough lasting between 24 and 72 hours. Participants will be randomly assigned to receive either Rengalin or a placebo, both given orally as 5 ml doses three times a day for 7 days. The study includes several visits: at the start (Day 1), at Day 4 for evaluation and potential addition of mucolytic therapy if needed, and at Day 8 for further assessment and sample collection. Parents will use an electronic diary to record their child's cough severity twice daily throughout the treatment period. During the study, doctors will monitor the child's condition, check for complications, and assess safety through physical exams, laboratory tests, and questionnaires. Follow-up continues up to 14 days, including a phone interview to evaluate recovery and any complications. The main result measured is the percentage of children who respond to the treatment by Day 3 compared to their baseline cough severity.

Researchers are evaluating the safety, immune response, and effectiveness of ANB-002, a gene therapy candidate, in male patients with Hemophilia B. This multicenter, open-label study uses a dose-escalation design combining elements of phase I and II to find the best dose. The goal is to understand how the treatment affects blood clotting factor IX (FIX) activity and to monitor for any adverse reactions over five years. The study involves four cohorts receiving single intravenous infusions of ANB-002 at increasing doses. Cohort 1 starts with dose 1, followed by cohorts 2 and 3 with higher doses if no dose-limiting toxicities occur. An independent committee reviews safety data before advancing doses or enrolling more participants. Cohort 4 includes patients with anti-AAV5 antibodies or hepatitis B history and receives the highest dose, dose 3. Participants are followed for five years, with close monitoring for changes in FIX activity and any side effects throughout this period. The study includes assessments to determine the best therapeutic dose and safety profile. Data from the first three cohorts guide decisions for further enrollment and dosing. This long-term follow-up helps evaluate the treatment's lasting impact and safety in patients with Hemophilia B.

Researchers are evaluating the effectiveness and safety of Raphamin in treating adults aged 18 to 75 years with acute rhinosinusitis, a condition characterized by symptoms such as facial pain and nasal congestion. This multicenter, double-blind, placebo-controlled, randomized clinical trial enrolls patients within 48 hours of symptom onset during the seasonal peak of acute respiratory viral infections. The study uses the Major Symptom Score (MSS) and Sino-Nasal Outcome Test (SNOT-22) to assess symptom severity and quality of life. Participants are randomly assigned to receive either oral Raphamin or a placebo following the same dosing schedule for five days. The trial includes a screening and randomization period of up to one day, a five-day treatment phase, and a follow-up period lasting up to 14 days. Patients attend three in-person visits on days 1, 4, and 7, with an additional phone visit on day 14. During these visits, symptom assessments, physical examinations, and diary reviews are conducted to monitor treatment adherence and safety. Patients keep an electronic diary twice daily to record body temperature and symptom changes according to the MSS. Investigators evaluate symptom progression, adherence, safety, and any complications including the use of antibiotics or hospitalizations. The primary outcome is the percentage of patients showing improvement in acute rhinosinusitis symptoms by day 4. Symptomatic and concomitant disease therapies are allowed except for prohibited medications. Overall, participants are observed for up to 14 days to assess treatment impact and safety.