View clinical trials related to Cystic Fibrosis.
Filter by:The study will be a randomized, cross-over study of THAM followed by saline or saline followed by THAM in human non-CF and CF subjects to assess nasal colonization
This will be a 5 year randomized, double blind, placebo controlled trial of 7 days of oral prednisone in cystic fibrosis (CF) patients receiving intravenous (IV) antibiotic treatment for a pulmonary exacerbation at the Hospital for Sick Children and other study sub-sites across Canada. The intervention will be oral prednisone 2 mg/kg/day (max 60 mg) divided twice daily for 7 days as an adjunctive therapy for pulmonary exacerbations in CF patients who have not recovered their baseline forced expiratory volume in 1 second (FEV1) after 7 days of IV antibiotic treatment. The primary outcome will be the proportion of subjects who achieve >90% of their baseline FEV1 % predicted at day 14 of IV antibiotic treatment for a pulmonary exacerbation in each treatment arm.
Cystic fibrosis (CF) is the most common fatal inherited condition in Caucasians, causing recurrent chest infections (pulmonary exacerbations). People with CF experiencing pulmonary exacerbation often require a 14day course of intravenous antibiotics and this treatment can either be delivered in hospital or in the community. Patients admitted to hospital are seen regularly by members of the CF multidisciplinary team (MDT), including doctors, nurses, dieticians and physiotherapists. This allows patients' progress to be closely monitored and also gives patients the opportunity to discuss any concerns or questions. In contrast, patients receiving IV antibiotics in the community are only seen by the MDT at the beginning and end of their 14 day course of IV antibiotics. Although CF nurses often visit patients on 12 occasions during the course of treatment, patients are not routinely reassessed by the rest of the MDT. There is therefore less opportunity for the MDT to adjust patients' treatment and for patients to communicate with the MDT. We therefore aim to study whether patients receiving IV antibiotics in the community benefit from monitoring their own oxygen saturations and lung function, as well as taking part in twice-weekly videoconferences with the MDT ('virtual care'). We expect that this will enable the MDT to to assess patients' progress more closely and allow patients to communicate with the MDT more easily. We will assess whether this improves patients' experience of their care and whether this translates into improvements in health and economic outcomes. One hundred subjects will be recruited over a 12month period, with 50 subjects allocated to 'virtual care' and 50 subjects allocated to 'routine care'. Subjects receiving 'routine care' will receive usual clinical care. The research team are well placed to perform the study because we are part of a large CF centre with an excellent record in clinical research.
Cystic fibrosis (CF) is a chronic hereditary respiratory disease. Exercise testing is part of CF patients regular assessment. Cardio-Pulmonary Exercise Testing (CPET) is currently considered as the gold standard to assess physical capacities. However, simple field tests are emerging. These tests are easier to perform especially in a population of CF children and adolescents. The 1minute Sit-To-Stand test have recently been evaluated in CF adults. This test correlates with maximal oxygen consumption during CPET. The investigators hypothesized that this test also correlates with 6-Minute Walking distance (during a 6-min Walk Test), quadriceps strength, respiratory muscles strength and health-related quality of life.
This study will evaluate the efficacy of ivacaftor treatment in subjects with CF 6 years of age and older who have a 3849 + 10KB C→T or D1152H CFTR mutation.
The aim of this study is to investigate the efficacy of antibiotic therapy with any antibiotic (IV) and IV (Nebcin®) tobramycin for 5 days followed by Solution for nebuliser inhalation (Tobi®) for 9 days and antibiotic cures using 14 days of tobramycin IV. In the case of positive results, the reduction of the duration of IV treatment of tobramycin from 14 days to 5 days would limit the risk of toxicity.
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, crossover study that will evaluate the efficacy of LUM/IVA in subjects with CF 12 years of age and older who have at least one A455E mutation.
A Safety Run-In will be followed by a Double-Blinded Randomized Phase. All subjects shall meet the inclusion/exclusion criteria, and will be evaluated prior to the scheduled infusion to establish baseline. There will be 3 subjects in the safety run-in phase and 15 subjects in the double-blinded phase.
Ascending dose, 7-day, open label safety trial of SPX-101 Inhalation Solution in adult subjects with cystic fibrosis.
Human Neutrophil Elastase (HNE) plays a pivotal role in innate immunity and in neutrophilic lung inflammation that characterized many diseases. CHF 6333 is a potent and 24h-durable inhibitor of HNE, developed as Dry Powder Inhaler (DPI) formulation. This study is designed to investigate the tolerability, safety and pharmacokinetics of inhaled CHF6333 DPI in healthy male subjects. The study will comprise two parts: Part 1 will consist of two alternated cohorts of healthy male subjects to assess the safety, tolerability and pharmacokinetics of Single Ascending Dose (SAD) of CHF6333. Part 2 will consist of four sequential cohorts of healthy male subjects to assess the safety, tolerability and pharmacokinetics of Multiple Ascending Dose (MAD) of CHF6333