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.

Clinical trials

Clear

1-5 of 63 results for all trials

Sort by:

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.

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.

Add to watchlist Find out more

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

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. Trial participants will be asked to take VX-445, tezacaftor and ivacaftor in the morning (2 tablets), and ivacaftor in the evening (1 tablet). Everyone in the study will receive all three of the study medications, no placebo is involved. This study is divided into two parts. Part A will recruit 12 people who will be asked to come into clinic around 6 times over 10 weeks. Part B will recruit 56 people who will be asked to come into clinic around 11 times over 32 weeks. During visits, the effect of the treatment on your CF will be measured with sample collection, lung function, questionnaires, and other medical checks.

CF START

CF START is a national UK trial that will determine the safest and most effective antibiotic strategy for infants diagnosed with cystic fibrosis (CF). 480 CF infants will be randomly allocated either flucloxacillin prophylaxis (the current UK standard of care) or antibiotics given in a more targeted manner. The primary outcome will be the age at first growth of Pseudomonas aeruginosa from a respiratory culture (an important safety measure for families). All outcomes will be recorded on a national CF Registry, including a number of secondary outcomes assessing effectiveness and safety. Finally at 40-48 months, a measure of respiratory function will be undertaken in a central laboratory, which will provide a clearer indication of the effectiveness of these two strategies.