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Current and upcoming Clinical Trials

DUE TO COVID-19 OUR TRIALS ARE CURRENTLY ONHOLD

 

Current trials - RECRUITING NOW

  1. OAS - An observational study to measure biomarkers, inflammation, and mediators from healthy volunteers and participants with airways disease at stable state and during acute exacerbation. 

    The purpose of this study is to understand more about conditions such as asthma, COPD, bronchiectasis and nasal polyps (conditions we often call ‘airways diseases’). We do not fully understand the mechanisms which cause these airways diseases and performing this research we hope will allow us to design better treatments for patients. We aim to build up a detailed picture of participants’ airways and how they are working

    A key aspect of the work is to compare participants without these conditions to participants with the condition, to try to determine why some people are affected while others aren’t. In order to do this we need to recruit people who do not have airways diseases (as ‘healthy controls’) too.

    We would also like to examine how these conditions affect patients and to do this we will look to collect information both when patients are stable and when they are undergoing an exacerbation, or flare, of their respiratory problems. Doing this may allow us to work out why people have exacerbations, and what might be done in future to prevent these.

    Another aspect is to work out what happens to patients when we give a treatment. In many cases though we know that treatments work, we often do not know exactly how they work, and looking into this might help us better identify which patients are likely to respond to which treatments, and perhaps to come up with new treatments too. We will not give any trial medications as part of this study but if as part of your normal care your medications are changed it can be useful to collect detailed information on how you are before and after this change.

  2. AES - INVESTIGATIONS OF IMMUNE MECHANISMS OF THE AIRWAY EPITHELIUM. Airway epithelial cells are the building blocks that make up the surface of the airways, known as the epithelium. This study aims to investigate defence mechanisms of these airway epithelial cells from patients with airways diseases. The airway epithelium has been shown to play roles in immunity, inflammation, tissue remodelling and host defence. Patients with inflammation in their airways are more susceptible to respiratory infections than healthy individuals, with epithelial cells proven to function differently in both asthma and Chronic Obstructive Pulmonary Disease (COPD) compared to health. The airway epithelium is the first place in the airways to come into contact with inhaled bacteria. It can communicate with other cells in the airway (immune cells) to kill the bacteria and prevent infection. We are particularly interested in discovering why some patients experience prolonged infections while others don’t. In the laboratory we will isolate cells from the samples you gift, and measure their responses when we add bacteria and other stimulants.
  3. STIFLE - Investigating Asthma inflammation in patients taking daily Asthma medication. Measurements will be performed daily by patients at home using devices which will connect to a smartphone.
      • Are you aged over 18
      • Have you been diagnosed with Asthma for longer than 6 months
      • Can you complete daily measurements at home for the next 6 months
      • Have you needed to use oral steroids for worsening asthma symptoms
    If so please contact one of our research team on 01865 227242 or Ouh-tr.stifle@nhs.net
    • Lung Gas Analyser (LGA) - An investigation into new measures of lung function. The assessment of lung function in patients with known or suspected lung disease is currently based upon measurements of how the lung is working as a whole, for example by measuring the speed of gas flow through the larger airways. However, many important lung problems affect only parts of the lung, and these so-called regional problems are very difficult to detect with current breathing tests. The purpose of this study is to investigate a new type of breathing test, which provides information about the regional variation of function within the lung. This is achieved though very accurate measurements of gas flow into and out of the lungs. These measurements are used by a mathematical model of the lung to estimate the variability of blood flow and gas flow within the lung, and to assess how well blood flow matches to gas flow.
    • CHINOOK - A Phase 4, Multicenter, Randomized, Double-blind, Parallel Group, Placebo Controlled Study to Evaluate the Effect of Benralizumab on Structural and Lung Function Changes in Severe Eosinophilic Asthmatics
    • HAMS - A prospective observational study using home monitoring devices for patients with asthma
    • OPTIMAN - The use of exhaled nitric oxide to manage asthma in primary care. The OPTIMAN study is designed to demonstrate how we can use a chemical that is measurable in the breath to better give treatments for asthma. Asthma is a huge problem in the United Kingdom, and it has been demonstrated that people who have asthma find it hard to know how much treatment to take. If they do not take the right amount of treatment, usually in the form of inhaled anti-inflammation medication, then they have an increased risk of symptoms and even possibly asthma attacks. By measuring the levels of nitric oxide (FeNO) in the breath we are able to adjust the doses of treatment and thus improve levels of control. The OPTIMAN study aims to do this for both those who have already been diagnosed and treated for asthma and for those who are coming to see their GP for the very first time with symptoms of asthma. We aim to get the diagnosis of asthma correct and then using FeNO optimise the drug treatment.

    If you are interested in taking part please do not hesitate to contact one of our research nurses on 01865 227242

    Current trials (Recruitment finished):

    1. CASCADE - A Phase 2, Randomized, Double-blind, Parallel Group, Placebo Controlled Study to Evaluate the Effect of Tezepelumab on Airway Inflammation in Adults with Inadequately Controlled Asthma on Inhaled Corticosteroids and at least one additional asthma controller.

    Upcoming Trials:

    1. ABRA STUDY- The use of Benralizumab, an interleukin-5 receptor-α monoclonal antibody as treatment of acute exacerbations of airways disease .
    2. CORAL STUDY - A 12-week exploratory study to characterise the relationship between changes in Inflammatory markers, lung function, symptoms and reliever use in Chronic Obstructive Pulmonary Disease Patients.
    3. RESOLUTE - A Multicenter, Randomized, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab 100 mg in Patients with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) with a History of Frequent COPD Exacerbations and Elevated Peripheral Blood Eosinophils
    4. BAYER COUGH STUDY - Study 20393, BAY 1817080 Randomized, double-blind, parallel group, Phase 2b dose-finding, efficacy and safety study of 12-week twice daily oral administration of BAY 1817080 compared to placebo in the treatment of refractory and/or unexplained chronic cough (RUCC).
    5. SHIONOGI COUGH STUDY