Trials Tracker

Due to COVID-19 some cystic fibrosis (CF) clinical trials may be still be temporarily paused, however some trials will begin to re-open soon. If you have any questions about taking part in clinical trials, please speak to our CF team or contact the Trust’s clinical trial team. Please also 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

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A study of the combined long-term effects of three CFTR modulator medicines in people with cystic fibrosis aged 12 and older (VX18 - 445 - 110)

In order to take part in this study you will already be taking part in the VX18-445-104 study. VX-445 is a medicine being studied for how well it works and how safe it is in people with cystic fibrosis (CF). Your participation in this study will help us learn more about how well VX-445 works in combination with tezacaftor and ivacaftor in people with CF with one copy of a CF gene with a mutation termed F508del and the other copy of a CF gene with a mutation termed gating or residual function. All three of the medicines are CFTR modulators which means that they help the faulty CFTR protein to function properly. Tezacaftor is already approved for use and is what is known as a corrector. Ivacaftor is also already approved for use and is what is known as a potentiator. VX-445 is a corrector. Everyone in the study will get the study medications. If you meet the rules for being in the study, you will take VX-445, tezacaftor and ivacaftor in the morning (in 2 pills), and ivacaftor in the evening (1 pill). You will be asked to come into clinic around 13 times over up to 100 weeks. During visits, we will measure how the drug is affecting your lung function and other measures of health with bloods and other samples, lung function, vital signs and other investigations. You will also receive 14 telephone consultations, each around half an hour, during this period. You do not have to come to clinics for these.

Hyperpolarised gas MRI and multiple breath inert gas washout to improve management and 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.

A study of the combined long-term safety of three CFTR modulator medicines in people with cystic fibrosis (VX19 445 115)

In order to take part in this study you will already be taking part in the VX18-445-109 study. VX-445 is a medicine being studied for how well it works and how safe it is in people with cystic fibrosis. Your participation in this study will help us learn more about the safety of taking VX-445 in combination with tezacaftor and ivacaftor for a long time. All three of the medicines are CFTR modulators which means that they help the faulty CFTR protein to function properly. Tezacaftor is already approved for use and is what is known as a corrector. Ivacaftor is also already approved for use and is what is known as a potentiator. VX-445 is a corrector. Everyone in the study will get the study medications. If you meet the rules for being in the study, you will take VX-445, tezacaftor and ivacaftor in the morning (in 2 pills), and ivacaftor in the evening (1 pill). You will be asked to come into clinic around 8 times over up to 52 weeks. During visits, we will measure how the drug is affecting health with bloods and other samples, vital signs and other investigations. You will also receive 7 telephone consultations, each around half an hour, during this period. You do not have to come to clinics for these.

A study of the combined effects of three CFTR modulator medicines in children with cystic fibrosis aged 6 to 11 (VX18-445-106)

VX-445 is an investigational medicine being studied to see how well it works and how safe it is in children with cystic fibrosis aged 6 to 11 years, when taken in combination with tezacaftor and ivacaftor. All three medicines are CFTR modulators which means that they help the faulty CFTR protein found in cystic fibrosis to work properly. Tezacaftor is already approved for use and is what is known as a ‘corrector’. Ivacaftor is also already approved for use and is what is known as a ‘potentiator’. VX-445 is a corrector

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.