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This is a Phase 3, 2-arm, multicenter study with an open-label ivacaftor arm and an observational arm to evaluate the safety and efficacy of long-term ivacaftor treatment in subjects with cystic fibrosis (CF) who are <24 months of age at treatment initiation and have an approved Ivacaftor-Responsive mutation
- Trials Tracker ID
- TT001851
- Age range
- Aged under 2 years
- Length of participation
- 104 weeks
- Trial status
- Recruitment complete
- Therapeutic approach
- Restore CFTR Function
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This is a Phase Ib, multi-center, open-label, nonrandomized multiple cohorts study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of a combination treatment of GLPG2451 and GLPG2222, with and without GLPG2737, in adult subjects with Cystic Fibrosis.
- Trials Tracker ID
- TT001846
- Age range
- 18+
- Trial status
- Closed with results
- Therapeutic approach
- Restore CFTR Function
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This trial has been archived
The single treatment group will enroll adult subjects with CF currently on stable KALYDECO® background therapy for a minimum of 3 months at the time of randomization. Subjects will be randomized to either PTI-428 or placebo. Each dose will be administered once daily (QD) for a total of 14 Days. The subjects will continue treatment with KALYDECO® throughout the study.
- Trials Tracker ID
- TT001826
- Age range
- 18+
- Length of participation
- 21 weeks
- Trial status
- Closed with results
- Therapeutic approach
- Restore CFTR Function
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This study investigates the use of cysteamine in the treatment of adults with Cystic Fibrosis who are experiencing an exacerbation of CF-associated lung disease. There are six different potential dosing regimens, including one that is placebo.
- Trials Tracker ID
- TT001821
- Age range
- 18+
- Length of participation
- 3 weeks
- Trial status
- Closed with results
- Therapeutic approach
- Mucociliary Clearance
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This trial has been archived
A CFit Study: To what extent does inflammation, oxidative stress, nitric oxide bioavailability and microvascular endothelial dysfunction influence the aerobic exercise function of individuals with cystic fibrosis, with and without established diabetes (The CFit Study)
- Trials Tracker ID
- TT001811
- Age range
- 12 years and older
- Trial status
- Closed with results
- Therapeutic approach
- Other
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Adults with CF regularly receive anti-infective therapy that can result in impaired hearing. Recent studies have identified that up to 50% of adults with CF have hearing loss with resulting significant impact on quality of life. At present, however, there is no national recommendation to screen for hearing loss within adult CF. Formal hearing tests are costly, require specialist staff and equipment and require further outpatient visits resulting in significant impact on health, social and financial resource. A novel interactive Apple-iPad app-based audiometer is now available and CE marked (Shoebox MD, Clearwater Medical) that can be used by non-audiologists to...
- Trials Tracker ID
- TT001796
- Age range
- 16+
- Length of participation
- Two visits which include three hearing tests, a blood test and questionnaires.
- Trial status
- Recruitment complete
- Therapeutic approach
- Other
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Evaluation of potential mucus clearing treatment for all patients with CF regardless of mutation
- Trials Tracker ID
- TT001791
- Age range
- 18 years and older
- Trial status
- Closed with results
- Therapeutic approach
- Mucociliary Clearance
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This trial has been archived
Through interviewing both the patient with CF and their families, this study hopes to establish a clearer picture of the effect the condition can have on the individual themselves and on their immediate family, in various aspects of their lives. From this, we hope to understand the key challenges facing these populations to help tailor the development of services.
- Trials Tracker ID
- TT001776
- Age range
- 11 years and older
- Length of participation
- 1 day
- Trial status
- Closed with results
- Therapeutic approach
- Behavioural
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Cystic Fibrosis (CF) affects more than 10000 people in the UK. The lungs of people with CF (PWCF) are prone to infections and require daily medication to stay healthy. Average adherence to medication has been shown to be only 36%. Poor adherence is associated with poor clinical outcomes including distressing unscheduled hospitalisations. Previous research has been undertaken to design a website (CFHealthhub) which records personal adherence data using chipped nebulisers and understand whether this can build successful treatment habits. In the current project we will develop CFHealthHub as a data observatory which will record adherence data and other indicators of...
- Trials Tracker ID
- TT001771
- Age range
- 16 years and older
- Length of participation
- >5 Years
- Trial status
- Recruitment complete
- Therapeutic approach
- Behavioural
