Rationale\nBronchiectasis is a condition characterised by dilated and thick-walled bronchi. The presence\nof Pseudomonas aeruginosa in bronchiectasis is associated with a higher hospitalisation\nfrequency and a reduced quality of life, requiring frequent and adequate treatment with\nantibiotics.\nObjectives\nTo assess local tolerability and the pharmacokinetic parameters of inhaled excipient free\ndry powder tobramycin as free base administered with the Cyclops dry powder inhaler to\nparticipants with non-cystic fibrosis bronchiectasis. The free base and absence of excipients\nreduces the inhaled powder dose.\nMethods\nEight participants in the study were trained in handling the device and inhaling correctly.\nDuring drug administration the inspiratory flow curve was recorded. Local tolerability was\nassessed by spirometry and recording adverse events. Serum samples were collected\nbefore, and 15, 30, 45, 60, 75, 90, 105, 120 min; 4, 8 and 12 h after inhalation.\nResults and Discussion\nDry powder tobramycin base was well tolerated and mild tobramycin-related cough was\nreported only once. A good drug dose-serum concentration correlation was obtained. Relatively small inhaled volumes were computed from the recorded flow curves, resulting in\npresumably substantial deposition in the central airwaysââ?¬â?i.e., at the site of infection.\nConclusions\nIn this first study of inhaled dry powder tobramycin free base in non-cystic fibrosis bronchiectasis\npatients, the free base of tobramycin and the administration with the Cyclops dry\npowder device were well tolerated. Our data support further clinical studies to evaluate\nsafety and efficacy of this compound in this population.
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