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

Clinical trials

Clear

1-5 of 64 results for all trials

Sort by:

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.

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.

A Phase 2 study of ABBV-3067 alone and in combination with ABBV-2222

In this study, participants will be given ABBV-3067 (“potentiator”) and ABBV-2222 (“corrector”) to see if treatment improves participants’ lung function. Different groups of participants will receive different doses, and some will receive a dummy drug (“placebo”). This study evaluates the safety and efficacy (how well the medications work) of the medications and the best dose of each medicine to be used in future studies. This is a Phase 2, double-blinded (treatment type is unknown to participants and investigators) study in people with CF who have two copies of the F508del mutation (the most common CFTR gene mutation). Participants go through a screening process (up to a month) and receive study treatment for up to a month, followed by a review, a month later. Tests done for the study include lung function tests, sweat chloride tests, blood and urine tests, and ECG. Side effects are monitored through the course of the study.

CFHealthHub Data Observatory

In the current project we will develop CFHealthHub as a data observatory which will record adherence data and other indicators of health and patient care held in patient notes. The purpose of this is two- fold; to support local and national Quality Improvement (QI) projects aiming to improve an individual’s adherence to treatment and the quality of care delivered by the CF centre. Secondly, collecting adherence data from a large number of PWCF may support future research studies whereby CFHealthHub is used as a source of participants and data.We aim to recruit PWCF who use chipped nebulisers from four CF centres across in England. PWCF will be consented to 1) share their identifiable data with their local CF team 2) share data, from which they cannot be identified, with all CF centres in the study 3) share data, from which they cannot be identified, in future research studies which result in no changes to their care and 4) share data to be included for selection to future studies which may result in changes to care, such as testing new treatments.Consent in any combination can be provided and withdrawn at any time. Participants who consent to 'selection' for future studies will also be provided with information specific to the new study and the opportunity to decline participation, if selected from the data observatory.

A study of three CFTR modulator medicines for how well they work together and their safety in people with cystic fibrosis aged 6 to 11 with one F508del mutation and one minimal function mutation (VX19-445-116)

In order to take part in this study you will have one F508del mutation and one minimal function mutation, and be aged 6 to 11. Elexacaftor (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 elexacaftor in combination with tezacaftor and ivacaftor. 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. Elexacaftor is a corrector. If you meet the rules for being in the study, you will take either: a combination of elexacaftor, tezacaftor and ivacaftor in the morning (in 2 tablets), and ivacaftor in the evening (1 tablet);or the same number of placebo tablets in the morning and evening. You will not know whether you are taking the study medications or a placebo. You will be asked to come into clinic around 9 times over up to 32 weeks. During visits, we will look for any changes in your health with bloods and other samples, vital signs and other investigations. You will also receive 3 telephone consultations, each around half an hour, during this period. You do not have to come to clinics for these.