Trials Tracker

Due to COVID-19 some cystic fibrosis (CF) clinical trials may be suspended with new trials postponed. Please see the relevant advice on the COVID-19 Q&A page. The Trials Tracker brings together all CF trials currently recruiting in the UK, so you can find clinical trials you can take part in both in your region and further afield. We are constantly updating and developing the functionality of the Trials Tracker – please help us by completing the online poll or contact us at clinicaltrials@cysticfibrosis.org.uk.

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A Study to Assess various doses of an ENaC inhibitor medication (mucociliary clearance) in Healthy Volunteers and People with Cystic Fibrosis

A study medication called ION-827359 is being developed to treat lung disease symptoms in people with cystic fibrosis. The study medication is intended to help treat the thick mucus found in the airways of patients with cystic fibrosis. This new inhaled (nebulized) medication will be investigated in both people with, and without cystic fibrosis. The study will compare the study medication with a placebo (a solution that looks identical to the study medication but contains no active ingredients), which means some participants will receive the study medication, whilst others will receive the placebo. Participants won’t know whether they are receiving the study medication or the placebo. Participation in the study lasts for approximately 21 weeks (just over 5 months), and will require numerous visits to complete study assessments (blood tests, questionnaires, lung function etc.) to the recruitment centre.

A study of MRI and lung function tests to improve understanding of cystic fibrosis lung disease

This study will assess two emerging lung function tests. The main test uses lung MRI after inhaling a hyperpolarized gas (HP MRI), which images gas distribution within the lung. This test has been demonstrated in CF patients to show lung disease before other conventional test. So far this technique has been limited to small cohorts and therefore needs to be measured in larger cohorts. The second test is a breathing test entitled multiple breath washout (MBW). This test is similar to HP MRI and is also able to detect lung disease prior to conventional tests. It also measures gas distribution within the lung, but without the regional detail of the MRI. The greater detail from the MR images will therefore be able to inform more about tests such as MBW. These tests will also be used to assess CF lungs after performing heavy exercise. Patients with CF become breathless when they exercise, however exercise is important as it improves their fitness and may help to remove mucus from the lung. Using MRI and MBW we will assess the effect of exercise on gas distribution within the CF lung. Children and adults with CF and a range of lung disease severity will be assessed. Patients will attend at three time points over two years and will perform MRI and MBW alongside standard breathing tests and a short quality of life questionnaire. At one visit patients will perform an exercise test followed by repeat MRI and MBW tests.

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Trial Reference Number
81036
Length of participation
2 years
Trial status
Recruitment on hold - COVID-19
Therapeutic category
Other

High Flow Nasal Therapy during exercise in CF

High flow nasal therapy (HFNT) is a way to deliver a mixture of air and oxygen at higher flows compared to standard oxygen therapy. It has been shown to improve oxygenation, reduce breathlessness and breathing rate, and is quite comfortable. Recently HFNT has been shown to improve exercise capacity and tolerance in patients with other lung diseases. HFNT is routinely used in clinical practice in patients with CF who present acutely unwell during hospital admissions. We believe that HFNT could be used by patients with CF during exercise in order to improve their tolerance, lengthen their exercise sessions, and allow them to be less symptomatic. We propose an initial, small-scale pilot study to assess the feasibility of a larger trial to assess efficacy. The study aims to enrol 20 patients with severe lung disease, during a hospital admission. On top of their routine 6-minute walking test, patients will be asked to have a repeated test on HFNT and to fill in a questionnaire on their physical activity. As exploratory outcomes, we will measure distance walked during the tests, oxygen and carbon dioxide levels, breathing rate, and time to recover to baseline. Patients will be asked to rate their comfort and their breathlessness.

AZTEC-CF

This study aims to investigate whether it is safe and effective to use one inhaled antibiotic and one via a drip, instead of the current standard of practice of two antibiotics via a drip. Participants will receive the two different treatments the next two occasions they need to be admitted to Liverpool Heart & Chest Hospital with a chest infection. On one admission they will receive two IV antibiotics, on the other admission they will receive one IV antibiotic and inhaled aztreonam (known as Cayston®). The order they receive each treatment will be picked at random. Participants will have measurements taken including lung function tests, blood tests, CF quality of life questionnaires, and sputum samples will be sent to the University of Liverpool for advanced analysis of the effect each treatment has on bugs in the lung. It is hoped that this study may help provide more information toward a much needed expansion of therapeutic options available in CF.

A dose finding study in patients aged 12 and above with cystic fibrosis using the Respimat® inhaler

The BALANCE CF TM1 trial will compare different doses of a new medication ‘BI 1265162’ and determine if this new medication is safe and effective to treat CF. This trial will also investigate how subjects’ bodies absorb and digest BI 1265162 by measuring study participants blood at specific intervals after taking the medication. The new medication BI1265162 is an ENaC inhibitor which means it blocks the epithelial sodium (Na) channel (ENaC) of the airway surface layer. By blocking this channel, your mucus should be less sticky which may improve your lung function. The medication is an inhaled oral medication using the Respimat® device. You will take the inhaler on top of your current CF treatment, whatever CF genes you have. If you are suitable to join the study, you will be randomly assigned to receive one of the different doses of BI1265162 or placebo. The trial will last approximately 7 weeks and involve 6 visits to the hospital. You will be asked to complete questionnaires, have blood samples, an ECG, lung function tests and a Multiple Breath Washout Test.