Wythenshawe

Researchers are evaluating KT-621, an oral drug, for its safety and effectiveness in treating adults with uncontrolled moderate to severe eosinophilic asthma. This Phase 2b randomized, double-blind, placebo-controlled trial aims to understand how KT-621 affects lung function and asthma control compared to a placebo. The study is sponsored by Kymera Therapeutics, Inc. and seeks to provide detailed information on KT-621s behavior in the body and its tolerability. Participants will be randomly assigned to one of four groups receiving different doses of KT-621 or a matching placebo. The treatment period lasts 12 weeks, during which participants take the study drug orally. The trial includes regular assessments to monitor lung function, asthma symptoms, and quality of life, with additional follow-up extending to 16 weeks to evaluate safety and drug levels in the blood. Throughout the study, participants will attend scheduled visits for lung function tests, questionnaires about asthma control and quality of life, and blood sampling to measure drug concentration and monitor safety. Researchers will track changes in lung function from the start through Week 12 and observe any adverse events up to Week 16. Participants are expected to comply with all study visits, treatments, and procedures, including keeping an electronic diary to record relevant health information.

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 tozorakimab as an additional treatment to standard care in adults hospitalized with viral lung infection who need supplemental oxygen. The study aims to determine if tozorakimab can help prevent death or the need for invasive mechanical ventilation or extracorporeal membrane oxygenation. This Phase III trial involves a large group of participants to assess the safety and effectiveness of this approach. Participants are randomly assigned to one of two groups one group receives a single intravenous dose of tozorakimab on the first day, while the other group receives a matching placebo. The study uses a double-blind design, meaning neither participants nor researchers know which treatment is given. This helps ensure unbiased results. The treatments are given once, and participants continue to receive standard care during the trial. During the study, participants are closely monitored and evaluated up to 60 days after treatment. Researchers track important outcomes such as death rates, progression to invasive ventilation, days alive outside intensive care, and oxygen use. They also assess clinical progression using a World Health Organization scale and monitor for any anti-drug antibodies. The trial lasts until November 2027, with multiple assessments throughout to understand the treatments impact and safety.

Mycobacterium abscessus MABS is a group of rapidly growing bacteria resistant to many drugs, causing lung infections that can lead to serious health problems, decreased lung function, and higher risk during lung transplants. The prevalence of MABS infections is increasing globally despite the relatively small number of affected people. The Finding the Optimal Regimen for Mycobacterium abscessus Treatment FORMaT trial aims to identify the best treatment combinations to improve health outcomes while reducing side effects and treatment burden. It also seeks to develop biomarkers to guide treatment decisions and assess disease severity in patients with MABS pulmonary disease MABS-PD. The trial is an ongoing, adaptive study designed to test and improve combinations of therapies for both children and adults with MABS-PD. Participants receive various drug treatments including intravenous therapies such as amikacin, tigecycline, cefoxitin or imipenem combined with oral antibiotics like azithromycin, clarithromycin, and clofazimine. The study includes phases of intensive intravenous therapy followed by consolidation therapy with oral andor inhaled antibiotics. Treatments can be adjusted based on tolerance and microbiological response, with new therapies added or removed as evidence evolves. Participants are involved in screening, treatment, and follow-up visits extending up to 62 weeks. The study monitors microbiological clearance of infection alongside treatment tolerance. Assessments include lung function tests, chest CT scans, quality of life questionnaires, six-minute walk tests, and evaluation of treatment safety and resistance. Researchers also study health costs and reasons for early withdrawal. This comprehensive monitoring helps understand how treatments affect disease control, lung health, and patient well-being over time.

Researchers are evaluating whether using MRI imaging for staging sigmoid colon adenocarcinoma can change treatment plans by detecting more high-risk tumors compared to standard CT imaging. This randomized phase II multicenter trial aims to improve radical treatment decisions and provide better prognostic information to patients. The study involves patients eligible for curative treatment whose MRI can be reviewed before surgery without a prior treatment decision. Participants are assigned randomly to one of three groups standard preoperative CT imaging with multidisciplinary team discussion, standard CT plus an additional preoperative MRI scan with team discussion, or observation only. The MRI provides supplementary diagnostic information that may alter treatment strategies based on local protocols. During the study, patients are followed up at 1 and 3 years with quality of life questionnaires. Researchers assess differences in cancer staging between CT and MRI, treatment changes, recurrence rates, disease-free survival, surgery quality, pathology outcomes, morbidity and mortality, and permanent stoma rates. The total follow-up extends up to 5 years after treatment, with outcomes measured at multiple time points to understand the impact of MRI staging on patient care.

Researchers are evaluating whether adding diffusion weighted MRI scans of the liver at diagnosis can detect more synchronous metastases than CT scans alone in patients with high risk colorectal cancer. This phase II multicenter study focuses on patients with advanced primary colorectal tumors who have no evidence of liver metastases on CT. The liver metastases found through the additional DW-MRI scans will be reviewed by a multidisciplinary team to determine appropriate management based on local protocols. Participants will undergo additional liver DW-MRI scans including T2-weighted, diffusion weighted imaging, and apparent diffusion coefficient sequences. These scans will be performed six months after surgery and then every six months for three years to monitor for liver metastases. If liver metastases are detected, treatment decisions will be made by the local multidisciplinary team following their standard procedures. During the study, participants will have regular imaging assessments to track the presence and progression of liver metastases. Researchers will analyze baseline tumor risk factors, patterns of metastatic relapse, and survival outcomes over time. The primary outcome is the detection and treatment of liver metastases as guided by local protocols, with follow-up to five years after the last patient is recruited. This study aims to improve understanding of liver disease progression in high risk colorectal cancer and assess the accuracy of DW-MRI as a screening tool.

Researchers are studying patients with newly diagnosed stage I, II, and III colorectal cancer CRC to understand how circulating tumor DNA ctDNA in the blood can predict disease relapse. The study evaluates whether using ctDNA to guide adjuvant chemotherapy decisions after surgery is as effective as standard chemotherapy, aiming to reduce unnecessary treatments and side effects. This multi-center, prospective research includes both observational and randomized components to better manage early-stage CRC. The study has two parts Part B focuses on collecting tumor tissue, serial blood samples, and clinical data to detect minimal residual disease MRD using ctDNA after curative surgery. Part C is a randomized trial comparing ctDNA-guided adjuvant chemotherapy versus standard care in patients with high-risk stage II or III CRC. Patients are randomized post-surgery to either standard chemotherapy or a ctDNA-guided approach where those testing negative for ctDNA may receive less chemotherapy. Participants will undergo regular blood sampling and clinical assessments to monitor ctDNA levels and disease status. Researchers will measure outcomes such as 3-year disease-free survival and the relationship between ctDNA detection and treatment response over several years. The study includes follow-up periods of 4 to 8 years to evaluate long-term outcomes and safety. Participants need to consent, adhere to follow-up schedules, and be suitable for chemotherapy if randomized to Part C.

This trial investigates transfusion strategies for younger patients aged 18 to 65 undergoing cardiac surgery with the use of cardiopulmonary bypass. It compares two common approaches to red blood cell transfusion thresholds to determine which is better for patients at moderate to high risk, focusing on important health outcomes after surgery. Participants are randomly assigned to one of two groups. One group receives a restrictive transfusion strategy, where transfusions are given only if hemoglobin levels drop below 75 gL during or after surgery. The other group follows a liberal transfusion strategy, with transfusions given at higher hemoglobin thresholds during surgery, in the intensive care unit, or on the ward. The study is open-label and conducted at multiple international centers. During the trial, researchers monitor participants for events such as death, heart attacks, kidney failure requiring dialysis, and neurological problems up to six months after surgery. They also track hospital stay length, infections, mechanical ventilation time, and other complications. Participants are followed closely through hospital discharge and for several months afterward to collect this important information.