Trials Tracker

Welcome to the Trials Tracker, bringing together all the cystic fibrosis (CF) trials currently recruiting in the UK so that you can find clinical trials you can take part in both in your region and further afield. The Trials Tracker is a new resource that we’ll be developing over time based on your feedback. If you’ve used the Trials Tracker and want to share your opinion, please complete our online poll or get in touch at clinicaltrials@cysticfibrosis.org.uk.

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A study to learn more about a combination of CFTR modulator medicines in people with Cystic Fibrosis (VX18-445 -104)

This study is being done to learn more about a new medication called ‘VX-445’ when taken in combination with tezacaftor and ivacaftor. All three of these medications are known as CFTR modulators. CFTR modulators work to treat the underlying genetic cause of cystic fibrosis. This combination of medication is being assessed in people with Cystic Fibrosis who are 12 years and older and who are heterozygous for the F508del mutation and a gating or residual function mutation. The study will investigate how well these medications work and to check that they are safe to use. It is the hope that this combination of medications will have positive effects in some people with Cystic Fibrosis Participants will be asked to come into the clinic at the recruitment centre 9 times over a 5 month period where a study assessment will take place (blood tests, questionnaires, lung function etc.).

Intravenous iron in adults with cystic fibrosis

Adults with cystic fibrosis often have low iron levels (iron deficiency). This is partly due to poor absorption of iron from the gut, and partly to the trapping of iron within cells of the immune system during periods of infection. Unfortunately, iron tablets are often ineffective in this setting, and may cause significant side effects in patients with cystic fibrosis. In other patient groups, intravenous iron is used routinely to correct iron deficiency. In these patients it has been shown to be safe, and to improve energy levels, exercise tolerance, cognitive function and quality of life, even in the absence of anaemia. Recent research suggests that iron may be particularly beneficial in patients with heart and lung disease. Despite these possible benefits, IV iron is rarely used in patients with CF, due in part to concerns about encouraging the growth of bacterial in the lungs. Iron deficiency therefore often goes untreated. However, since no clinical trials have examined the use of IV iron in CF patients to date, the risks and benefits remain uncertain. We plan to undertake a small pilot study examining the effects of IV iron in 20 adults with CF and low iron levels. We will primarily assess whether intravenous iron is safe and effective at treating iron deficiency in this group, but will also study various other clinical parameters, to guide the design of future larger studies.

A study to evaluate the safety and tolerability of a new antimicrobial medicine in people with cystic fibrosis (CF) and non-CF bronchiectasis

ALX-009 is composed of hypothiocyanite ion (OSCN-) and lactoferrin, two substances that are naturally occurring components of the immune system in the lungs but are lacking in CF patients’ lungs. It has been demonstrated in vitro that OSCN- and lactoferrin are capable of killing all tested Gram(-) bacteria, including bad bugs resistant to available antibiotics. This clinical trial is split into four parts. People with CF or bronchiectasis are planned to be enrolled in the fourth part, the main purpose of which is to assess the safety of ALX-009 after repeated administration of increasing doses. The doses will be chosen on the basis of the results obtained from the previous parts of the study in healthy volunteers. The study takes place over approximately 5 weeks including one screening visit, a treatment period of 7 consecutive days, twice daily and a final study visit.

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Trial Reference Number
111543
Age
18+
Trial status
Project in Setup
Therapeutic category
Anti-Infective

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. PLEASE NOTE THERE ARE LIMITED PARTICIPATION SLOTS AVAILABLE FOR THIS TRIAL – WE THEREFORE EXPECT RECRUITMENT TO COMPLETE QUICKLY.

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

The BALANCE CF™1 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.