Wythenshawe

Researchers are evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of two different dose levels of solrikitug compared to placebo in people with Chronic Obstructive Pulmonary Disease (COPD). This Phase 2 study includes participants who have had COPD for at least 12 months and have elevated blood eosinophil levels. The trial aims to understand how solrikitug affects blood eosinophil counts and other health measures related to COPD. Participants will be randomly assigned to receive either low-dose solrikitug, high-dose solrikitug, or a placebo. These treatments are given by subcutaneous injection at the study site over a 12-week period. After treatment, there is a 16-week follow-up period to monitor participants for any lasting effects or safety concerns. During the study, participants will have regular assessments including lung function tests, blood tests to measure eosinophil counts, and evaluations of COPD symptoms. Researchers will monitor safety and tolerability closely throughout the treatment and follow-up periods. The total time commitment for participants covers the 12 weeks of treatment plus the 16 weeks of follow-up, totaling 28 weeks.

Researchers are evaluating the effects and safety of AZD6793 tablets in adults aged 40 years and older who have moderate to very severe chronic obstructive pulmonary disease (COPD). This is a Phase IIb, multicenter, randomized, double-blind, placebo-controlled study involving approximately 1160 participants at around 400 sites worldwide. The study aims to compare three different doses of AZD6793 against placebo tablets over 24 weeks to assess how well the treatment works and its safety profile in this population. Participants will be randomly assigned to one of four groups receiving either one of three doses of AZD6793 or a placebo in equal proportions. The treatment involves oral administration of AZD6793 tablets or placebo tablets daily for 24 weeks. The study is designed with parallel groups and includes careful dose-ranging to evaluate different levels of the investigational drug. During the study, participants will be monitored for the annualized rate of moderate or severe COPD exacerbations from baseline up to 24 weeks. Assessments include lung function tests such as pre- and post-bronchodilator FEV1/FVC ratios, symptom questionnaires like the COPD Assessment Test (CAT), and documentation of COPD exacerbation history. Safety will be continually evaluated through clinical assessments and laboratory tests throughout the treatment period.

Researchers are evaluating the effect of tozorakimab, added to standard care, in adults hospitalized with viral lung infection who need supplemental oxygen. The study focuses on preventing death or progression to invasive mechanical ventilation or extracorporeal membrane oxygenation by day 28. This is a Phase III, multicenter, randomized, double-blind trial comparing tozorakimab to placebo in patients with viral lung infection causing acute respiratory failure. Participants will receive a single intravenous dose of either tozorakimab or a matching placebo on the first day of the study. Both groups continue to receive standard care for their viral lung infection. The study is designed to assess the safety and efficacy of tozorakimab as an add-on therapy in this patient population. Throughout the study, researchers will monitor participants for survival and the need for invasive mechanical ventilation or ECMO up to 28 days after treatment. The main outcome measured is the proportion of patients who die or require mechanical ventilation or ECMO by day 28. Participants will be closely observed during hospitalization, with data collected on their respiratory status and treatment outcomes to evaluate the study drug's impact and safety.

Mycobacterium abscessus (MABS) is a group of rapidly growing, multi-drug resistant bacteria that can cause serious lung infections, especially in people with underlying inflammatory lung conditions. These infections, called MABS pulmonary disease (MABS-PD), can lead to worsened lung function, increased healthcare needs, and reduced quality of life. The trial, called Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT), aims to find the best treatment plans to clear MABS infections while minimizing side effects and treatment burdens. It also seeks to develop biomarkers to help guide treatment decisions and measure disease severity. The trial uses an innovative platform design to test and improve different treatment combinations for both children and adults with MABS-PD. Treatments include various intravenous and oral antibiotics such as amikacin, tigecycline, imipenem, cefoxitin, azithromycin, clarithromycin, clofazimine, ethambutol, linezolid, co-trimoxazole, doxycycline, moxifloxacin, bedaquiline, and rifabutin. The study includes phases of intensive intravenous therapy followed by consolidation with oral and/or inhaled antibiotics. Different durations and combinations of therapy are tested, including short and prolonged intensive treatments and consolidation therapies with or without inhaled amikacin. Participants will be involved in the study for up to 62 weeks, depending on their treatment group. Throughout the study, researchers will collect respiratory samples to monitor bacterial clearance and evaluate tolerance to treatments using standardized criteria for side effects. Additional assessments include quality of life measures, gene expression, imaging, and antibiotic resistance studies. The trial also includes an observational cohort for participants not receiving active treatment, allowing transition to the intervention program if eligible. Safety and treatment response will be closely monitored during and after therapy.

This research aims to assess whether adding MRI imaging to the standard CT imaging for patients with suspected or confirmed sigmoid colon adenocarcinoma influences treatment decisions. The study compares standard preoperative CT and multidisciplinary team discussions against adding MRI scans to see if MRI identifies more high-risk tumors, potentially changing treatment plans and prognosis information. Participants are randomly assigned to either the control group receiving standard care with CT imaging or the intervention group receiving an additional MRI scan before surgery. Both groups undergo multidisciplinary team reviews based on their imaging results. The intervention involves extra radiological and pathological assessments and reporting that might affect treatment choices following local protocols. Participants are followed up at 1 and 3 years after recruitment, including quality of life questionnaires. The study measures differences in cancer staging on CT versus MRI and how these differences impact treatment strategies. The total follow-up duration extends up to three years after the last participant is recruited, ensuring long-term observation of outcomes and treatment effects.

Researchers are evaluating the use of rademikibart as an additional treatment for adults and adolescents with asthma experiencing an acute exacerbation linked to type 2 inflammation. This Phase 2, randomized, double-blind, placebo-controlled trial aims to compare the effects of rademikibart plus standard therapy versus standard therapy alone in urgent healthcare settings. The study focuses on participants who have a history of asthma and require urgent treatment for an acute asthma exacerbation. Participants will receive either 600 mg of rademikibart administered subcutaneously via a prefilled syringe or a matching placebo injection alongside their standard asthma treatment. The trial is designed as a parallel-group study to assess the added impact of rademikibart during acute episodes. The treatment is given once during the urgent care visit for the exacerbation. Throughout the study, researchers will monitor participants for treatment failure within 28 days after randomization. Assessments include lung function tests such as FEV1, blood tests for eosinophil counts, and clinical evaluations of asthma control and exacerbation status. The trial also carefully tracks safety and efficacy outcomes during this 28-day period to understand how well rademikibart works as an add-on treatment.

Researchers are conducting a Phase 2, randomized, double-blind, placebo-controlled trial to study adults aged 40 to 80 years with an acute exacerbation of chronic obstructive pulmonary disease (COPD) who also have type 2 inflammation. The study aims to compare the effects of adding rademikibart to standard therapy versus standard therapy alone in an urgent healthcare setting. Participants have a history of COPD with at least one previous exacerbation and meet specific blood eosinophil or FeNO levels indicating type 2 inflammation. Participants will receive either 600 mg of rademikibart or a matching placebo, both administered as a 4 mL subcutaneous injection. This treatment is given in addition to their usual standard care, which includes systemic corticosteroids. The study follows a parallel-group design where participants are randomly assigned to one of the two treatment groups, and neither the participants nor the researchers know which treatment is given. During the study, participants will undergo assessments to monitor their response to treatment and safety. The primary outcome being measured is the rate of treatment failure within 28 days. Researchers will also evaluate various health parameters and monitor for any side effects. The total participation duration and follow-up procedures are designed to ensure thorough evaluation of the treatment's impact on acute COPD exacerbations with type 2 inflammation.

Researchers are evaluating if using additional liver diffusion weighted MRI (DW-MRI) scans at diagnosis can find more synchronous liver 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 scans. The goal is to improve detection and management of liver metastases by sharing MRI findings with multidisciplinary teams for treatment decisions. Participants will undergo additional breath hold T1, T2, and DW-MRI liver scans without intravenous contrast every six months for three years after surgery. Any liver metastases detected on these scans will be reviewed by the local multidisciplinary team and treated following local protocols. This ongoing monitoring aims to identify metastases early and guide appropriate therapy. During the study, participants will have regular imaging assessments and clinical evaluations as part of their post-surgery surveillance. The researchers will measure the presence of liver metastases through these MRIs and track treatment responses. Findings will be discussed in multidisciplinary team meetings, and participants will be followed for five years after the last recruitment to assess long-term outcomes and management of liver metastases.

Researchers are evaluating the effects of Taplucainium Inhalation Powder (NOC-110) in adults aged 18 to 80 who have refractory or unexplained chronic cough lasting at least 12 months. This phase 2b study aims to assess the medicine's efficacy, safety, and tolerability compared to a placebo in a randomized, double-blind, controlled setting. The study will involve about 455 participants, with up to 1264 screened to identify eligible adults. Participants will receive either NOC-110 inhalation powder or a matching placebo once daily during the treatment period. The study includes a screening phase followed by approximately 13 weeks of participation, during which participants will use the assigned inhalation powder. The trial is designed to monitor how the treatments impact cough frequency and overall tolerability over this period. Throughout the study, participants will be closely monitored for changes in their 24-hour cough rates, measured from baseline to the end of treatment. Researchers will also assess safety and any side effects. Participants will provide informed consent and follow contraceptive guidance if applicable. The study includes detailed tracking of medical history, respiratory health, and other relevant factors to ensure participant safety and gather comprehensive data on treatment effects.

Researchers are investigating colorectal cancer (CRC) patients with newly diagnosed stage I, II, and III cancers to evaluate whether mutations in circulating tumor DNA (ctDNA) can predict disease relapse earlier than current methods. This study includes two parts: Part B focuses on analyzing tumor tissue, serial blood samples, and clinical data to detect minimal residual disease (MRD) and predict relapse, while Part C is a randomized study comparing ctDNA-guided adjuvant chemotherapy to standard care in high-risk stage II or III CRC patients post-surgery. In Part B, the study collects serial blood samples from patients who have undergone potentially curative surgery to detect and quantify ctDNA, aiming to identify MRD and predict relapse. Part C randomizes patients after surgery into two groups: one receiving standard adjuvant chemotherapy and the other receiving ctDNA-guided chemotherapy, where those testing ctDNA negative may have chemotherapy reduced. The goal is to assess if ctDNA-guided treatment can safely reduce chemotherapy use without compromising disease-free survival. Participants will undergo tumor tissue collection, blood sampling at multiple time points, and clinical assessments over several years. Researchers will monitor ctDNA levels and clinical outcomes, measuring disease-free survival up to 3 to 6 years. Safety and treatment effects will be evaluated, with follow-up visits to track relapse and treatment response. Total participation includes long-term monitoring for relapse prediction and chemotherapy guidance.