Llandough

Researchers are evaluating the use of epigenome-guided treatment selection compared to the usual standard-of-care SOC treatment for adults with active Crohns Disease CD. This study aims to assess the effectiveness, safety, and cost-effectiveness of using an epigenetic biomarker assay and machine-learning software called EpiPredict to help choose between two biologic therapies, Vedolizumab VDZ and Ustekinumab UST, for treating active CD. The trial includes participants who have active disease and are either new to biologic therapy or have had limited prior biologic exposure. Participants will be randomly assigned to one of two groups one group will receive biologic treatment guided by the EpiPredict software based on epigenetic blood tests, which indicates the likelihood of response to VDZ or UST, while the other group will receive biologic therapy following usual SOC without epigenetic guidance. Both groups will receive their biologic therapy according to approved product labels, with dose adjustments allowed as needed by the treating doctor. Treatment and assessments will be carried out over 26 weeks, with different assessment schedules depending on the biologic received. After this treatment period, participants will have long-term follow-up every six months up to 24 months. During the study, participants will provide blood samples for epigenetic testing and undergo clinical and endoscopic evaluations to monitor their disease activity and response to treatment. Data will also be collected from routine medical records and online questionnaires during follow-up visits. The primary measurement is the comparison of clinical remission and endoscopic response rates at Week 26 between the two treatment selection methods. Researchers will also evaluate cost-effectiveness and explore how well the epigenetic assay predicts treatment success. Participants are required to comply with study procedures and provide informed consent to participate fully.

Chronic obstructive pulmonary disease COPD is a common lung condition affecting many adults worldwide, with exacerbations leading to worsening health and hospital admissions. This trial focuses on patients recently discharged after a hospital stay for a COPD exacerbation, aiming to reduce the risk of readmission and improve outcomes during the critical 90-day high-risk period after discharge. The study is a phase 3, multicenter randomized controlled trial addressing an important healthcare challenge and potential cost savings for the NHS. The trial compares a supported rescue pack management plan to standard care. Participants in the supported rescue pack group receive a 5-day rescue pack of prednisolone and antibiotics, a written self-management plan based on the Asthma-Lung UK plan, and twice-weekly automated phone or text symptom assessments for 90 days. Those in the standard care group do not receive rescue packs on discharge but may access them through community care. The trial will monitor the use of rescue packs and support provided during the 90-day period. Participants will be involved in regular symptom monitoring through automated calls or texts and follow-up assessments. Researchers will measure time to first hospital readmission within 90 days as the primary outcome, along with secondary outcomes including readmission frequency, days alive and out of hospital, corticosteroid and antibiotic use, healthcare contacts, quality of life, and cost-effectiveness. Safety monitoring will include adverse events and antimicrobial resistance over an average of 4 years, with participant involvement lasting up to one year for some assessments.