Schleswig

Researchers are evaluating the effect of AZD6793, an oral medication, in adults with moderate to very severe chronic obstructive pulmonary disease COPD. This Phase IIb, randomized, double-blind, placebo-controlled study involves approximately 970 participants across about 350 global sites. The trial aims to compare the efficacy and safety of two different doses of AZD6793 against placebo over a 24-week period. Participants will be randomly assigned to one of three groups receiving either dose 1 of AZD6793, dose 2 of AZD6793, or a matching placebo tablet. The study medication is taken orally and the trial lasts for 24 weeks. The study is designed as a parallel-group format with a 111 allocation ratio among the three arms. During the study, participants will be monitored through various assessments including lung function tests measuring forced expiratory volume FEV1, questionnaires evaluating breathlessness, cough, sputum, and quality of life, and tracking of COPD exacerbation events. Blood samples will be collected to measure plasma concentrations of AZD6793. Safety and efficacy outcomes will be evaluated up to 24 weeks, with the main outcome being the rate of moderate or severe COPD exacerbations.

Researchers are evaluating the effects of NNC0487-0111 in adults with excess body weight and obstructive sleep apnea who are not using positive airway pressure treatment. This Phase 3 trial aims to assess the safety and effectiveness of this medication in helping participants lose weight and improve their sleep apnea. The study compares NNC0487-0111 with a placebo, which is an inactive treatment given by chance to participants. Participants receive weekly injections of either NNC0487-0111 or a matching placebo under the skin using pre-filled pen injectors applied to the thigh, abdomen, or upper arm. Both groups follow a reduced-calorie diet and increase physical activity during the study. The treatment period lasts for 80 weeks, during which researchers monitor changes in body weight and sleep apnea severity. Throughout the study, participants undergo regular assessments including body weight measurements and evaluation of the apnea-hypopnea index AHI to track sleep apnea severity. Additional tests measure sleep-related impairment, blood pressure, cholesterol levels, and blood sugar control. Safety is monitored by tracking any adverse events during the 84 weeks of the study. Participants progress is carefully followed to understand the impact of the treatment on weight and sleep apnea over time.

Researchers are evaluating the effectiveness and safety of NNC0487-0111 in adults with overweight or obesity who also have obstructive sleep apnoea and are being treated with positive airway pressure. This phase 3 study compares NNC0487-0111 to a placebo, which contains no active medicine, to see how well the treatment helps with weight loss and improvement in sleep apnoea symptoms. Participants will receive one of two dose levels of NNC0487-0111 or a matching placebo as weekly injections under the skin. These injections are given alongside a reduced-calorie diet and increased physical activity. The treatment is administered using pre-filled pen injectors to the thigh, abdomen, or upper arm, and the study lasts for 80 weeks. Throughout the trial, participants will be monitored regularly to assess changes in body weight, sleep apnoea severity measured by the apnoea-hypopnoea index AHI, and other health measures such as waist and neck circumference, blood pressure, cholesterol, blood sugar, and sleep quality scores. Safety is tracked by recording any treatment-related adverse events. The study runs until week 80, with follow-up continuing through week 84 to evaluate ongoing safety and effectiveness.

Researchers are evaluating depemokimab as a treatment for adults aged 40 to 80 with moderate to severe chronic obstructive pulmonary disease COPD who have type 2 inflammation and uncontrolled symptoms despite standard care. The study aims to assess the safety and effectiveness of depemokimab compared to a placebo when added to the usual treatment. This phase 3 trial is sponsored by GlaxoSmithKline and focuses on reducing COPD exacerbations and improving respiratory symptoms over a long period. Participants will receive either depemokimab by subcutaneous injection alongside their standard inhaler therapy or a placebo injection plus standard care. The study is randomized, double-blind, and includes two groups one receiving depemokimab and the other a placebo, both continuing optimized inhaler treatments. This study will last up to 104 weeks, with regular assessments throughout. During the study, participants will undergo evaluations including lung function tests, symptom questionnaires such as the COPD assessment test and St. Georges Respiratory Questionnaire, and monitoring for COPD flare-ups or hospital visits. Researchers will track the number and severity of exacerbations and changes in quality of life measures. Safety and tolerability will also be closely monitored throughout the trial duration, which extends up to two years.

Researchers are evaluating photothermal therapy using the Navilas Laser System for people aged 60 to 90 with intermediate Age-related Macular Degeneration iAMD. The study aims to show that this personalized treatment plan can safely improve photoreceptor health and slow disease progression by preserving the Ellipsoid Zone Integrity EZI. Participants will be randomized into either a treatment group or a control group to compare outcomes over time. Participants will receive either individualized photothermal therapy or a sham treatment in the study eye. The study involves 12 visits monthly visits during the first three months, followed by quarterly visits for up to two years. The primary measure of success is the preservation of EZI at 12 months, with additional outcomes including changes in drusen progression, rates of geographic atrophy or neovascular AMD development, and vision loss measured over 24 months. During the study, participants will undergo regular eye exams and assessments to monitor vision and retinal health. Researchers will measure visual acuity changes and track disease progression using imaging and clinical evaluations. The study includes safety monitoring and thorough follow-up across the two-year period to assess long-term effects of the treatment on intermediate AMD progression.

Researchers are studying severe asthma by creating a detailed clinical registry to better understand and improve care for patients with this condition. The German Asthma Net e.V. focuses on gathering reliable data on the incidence, prevalence, different types, and treatments of severe asthma. This registry helps connect several clinics and practices across Germany to optimize diagnosis and treatment for patients. Information collected includes sociodemographic data like gender and birthdate, medical details such as diagnosis and therapies, and measures of lung function, allergy markers, asthma control, smoking status, and related treatments. Data are collected at the initial visit and then yearly for up to 15 years to track progress and changes. Participants receive a unique study ID to keep their personal health information confidential. Researchers will regularly assess asthma symptoms, lung function, medication changes, quality of life, and healthcare usage over the study period. The long-term follow-up allows monitoring of asthma control and related health outcomes in detail.

Researchers are evaluating the safety and efficacy of intravenous thrombolysis IVT in adults who have experienced an acute ischemic stroke AIS and have taken direct oral anticoagulants DOAC within the last 48 hours. This international, multicenter, randomized trial compares IVT plus standard care to standard care alone in 906 participants to determine if IVT leads to better outcomes 90 days after treatment. Participants are randomly assigned to one of two groups one receives intravenous Tenecteplase or Alteplase along with the best medical treatment following local guidelines, while the other receives only the best medical treatment. The treatment is administered according to current recommendations from leading stroke organizations. The study aims to test whether IVT is superior in improving recovery in AIS patients with recent DOAC intake. During the study, participants are monitored and evaluated at multiple time points, including assessments of stroke severity, functional outcomes using the Modified Rankin Scale at 90 days, and quality of life questionnaires. Safety and efficacy are carefully tracked through these measures. Participants progress is followed up to about 90 days after randomization to assess the main outcomes and overall health status.

Researchers are evaluating the effects of switching from combustible cigarettes to a Tobacco Heating System THS in adults with COPD and chronic bronchitis. This randomized study aims to show clinical benefits in symptoms such as cough frequency and shortness of breath, as well as lung function and exercise ability measured by a six-minute walk test. The study focuses on how patients feel and function when switching to THS compared to continuing cigarette smoking. Participants are randomly assigned to either continue smoking cigarettes or switch to using the THS freely without flavor restrictions. The study lasts for 24 weeks, during which the participants use their assigned product as they wish. Researchers compare changes in symptoms, lung function, cough severity, and exposure to harmful substances between the two groups over this period. Throughout the 24 weeks, participants undergo various assessments including cough frequency monitoring, lung function tests, quality of life questionnaires related to cough, and measurements of nicotine and carbon monoxide exposure. These evaluations occur at multiple time points such as weeks 1, 4, 12, and 24. The study tracks symptom changes, respiratory function, and overall health status while ensuring safety monitoring and adherence, providing a comprehensive view of the effects of switching products for people with COPD.

Researchers are evaluating the effectiveness and safety of tebentafusp-based treatments for patients with advanced non-ocular melanoma who have previously been treated. The study compares tebentafusp alone, tebentafusp combined with pembrolizumab, and the investigators choice of therapy, including other clinical trials or standard care options. This phase 3, open-label, multicenter trial focuses on patients who have progressed after previous immunotherapy and targeted treatments if applicable. Participants are randomly assigned to one of three groups tebentafusp alone, tebentafusp with pembrolizumab, or the investigators choice of therapy. The treatments are given according to protocol with ongoing evaluation. The study includes long-term follow-up of up to about four years to assess overall survival and other health outcomes. During the study, participants will undergo various assessments, including tumor evaluations, blood tests for circulating tumor DNA and drug levels, and quality of life questionnaires. Safety will be closely monitored by tracking adverse events and immune reactions. Study visits and evaluations will occur at designated time points over the treatment and follow-up periods to measure treatment impact and participant well-being.