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Poor adherence is associated with poor clinical outcomes including distressing unscheduled hospitalisations. We have designed an intervention that will feedback adherence data to PWCF using chipped nebulisers displaying real time treatment use on smartphones and the website (CFHealthhub). Feedback is a powerful support to habit formation and the interventionist will use CFHealthHub and a behaviour change manual to support PWCF in building successful treatment habits. This work package follows on from a successful Pilot and Feasibility study that successfully met the recruitment target to deem the main RCT feasible. This was based on recruiting 64 PWCF over four months at...
- Trials Tracker ID
- TT001711
- Age range
- 16 years and older
- Length of participation
- 12 months
- Trial status
- Closed with results
- Therapeutic approach
- Behavioural
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The study drug, called RPL554, is a potential new inhaled drug that is being developed for the treatment of breathing and lung diseases, including cystic fibrosis. The study drug is a liquid that is breathed in using a device called a nebuliser, which is a commonly used device that turns a liquid into a fine mist that can then be inhaled into the lungs where it can then be taken into the body. Over 240 people have been given RPL554 in clinical studies so far. Two different formulations (how the drug is made up) have been tested in these studies...
- Trials Tracker ID
- TT001701
- Age range
- 18 years and older
- Length of participation
- 52 days
- Trial status
- Closed with results
- Therapeutic approach
- Anti-Inflammatory
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This is a Phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis (CF) with one F508del CFTR mutation and a second gating (class III) mutation. Up to 35 participants are planned to be included in the study for a minimum of 6 weeks and a maximum of 10 weeks. All participants will be at least 18 years of age and have cystic fibrosis with at least one copy of the F508del (Class II) mutation. This study will investigate whether treatment with the corrector GLPG2222 in patients heterozygous for F508del and a gating mutation who...
- Trials Tracker ID
- TT001681
- Age range
- 18 years and older
- Trial status
- Closed with results
- Therapeutic approach
- Restore CFTR Function
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The Cystic Fibrosis working group recent recommendations commended the use of physical exercise as part of a multidisciplinary therapeutic strategy, as it has been proven to lower mortality risks in patients. One nonpharmacological intervention which has shown some promising results in recent years is inspiratory muscle training (IMT), which may improve patients’ respiratory muscle and exercise function. Inspiratory muscle training, which involves breathing through a device that provides resistance when you breathe, aims to improve the strength of the lung muscles by making them work harder and therefore making them stronger. Starting IMT in children at the early years of...
- Trials Tracker ID
- TT001676
- Age range
- 8 years and older
- Length of participation
- 8 - 16 weeks
- Trial status
- Closed with results
- Therapeutic approach
- Other
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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...
- Trials Tracker ID
- TT001671
- Age range
- 0 to 4 years
- Length of participation
- 48 months
- Trial status
- Recruitment complete
- Therapeutic approach
- Anti-Infective
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This study will look at whether two drugs (called lumacaftor and ivacaftor) can help treat cystic fibrosis when taken together over a long period of time. It will also look at whether they are safe over this period. You can only take part in this study if you took part in a study called VX14-809-109, and if you meet certain criteria. These criteria will be checked by the study doctor and nurse at a screening visit. If you meet these criteria you will be treated with lumacaftor and ivacaftor together for approximately 96 weeks. A follow up visit will be...
- Trials Tracker ID
- TT001661
- Age range
- 6 years and older
- Length of participation
- 96 weeks
- Trial status
- Closed with results
- Therapeutic approach
- Restore CFTR Function
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This trial has been archived
This study aims to find out if CF patients benefit from ‘virtual care’ while they are receiving intravenous (IV) antibiotics in the community. ‘Virtual care’ is a term that we are using to describe the provision of regular videoconferencing with the CF team as well as equipment to allow patients to monitor their own lung function and oxygen saturations.
- Trials Tracker ID
- TT001656
- Age range
- 18 years and older
- Length of participation
- 2 weeks
- Trial status
- Closed with results
- Therapeutic approach
- Other
Search result from the Trials Tracker
This trial has been archived
Cystic fibrosis affects around 10,000 people in the UK and an estimated > 100,000 worldwide. It is a multisystem condition, with lung disease being the most significant, leading to early infection, inflammation and scarring. Currently, despite huge improvements in clinical care, the median age of death in the UK is just over 30 years. Babies are now diagnosed on newborn screening and are usually asymptomatic, but lung disease begins early. Disease progression is variable and influenced by a number of factors, one of the most important being the frequency of pulmonary exacerbations (PEx), poorly understood periods of increasing symptoms and...
- Trials Tracker ID
- TT001646
- Age range
- Between 0 and 17 years
- Length of participation
- 6 Months
- Trial status
- Closed with results
- Therapeutic approach
- Other
