This clinical trial is focused on studying Cystic Fibrosis, a genetic disorder that affects the lungs and other organs. The study will use a combination therapy involving three medications: Tezacaftor, Deutivacaftor, and Vanzacaftor, which are taken as a film-coated tablet. These medications are designed to work together to help improve the function of certain proteins in the body that are affected by cystic fibrosis.
The purpose of the study is to evaluate the long-term safety and tolerability of this combination therapy in individuals with cystic fibrosis. Participants will take the medication over a period of time and will have regular check-ups to monitor their health. These check-ups will include assessments of vital signs, laboratory tests, and other evaluations to ensure the treatment is safe and well-tolerated.
Throughout the study, researchers will also look at how the treatment affects lung function, measured by a test called percent predicted forced expiratory volume in 1 second (ppFEV1), and the level of sweat chloride, which is a marker of cystic fibrosis. Additionally, the study will track the number of lung infections, known as pulmonary exacerbations, that participants experience. This information will help determine the effectiveness of the treatment in managing cystic fibrosis symptoms over the long term.
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