RT Journal Article SR Electronic T1 Efficacy and safety of TOBI Podhaler in Pseudomonas aeruginosa-infected bronchiectasis patients: iBEST study JF European Respiratory Journal JO Eur Respir J FD European Respiratory Society SP 2001451 DO 10.1183/13993003.01451-2020 VO 57 IS 1 A1 Michael R. Loebinger A1 Eva Polverino A1 James D. Chalmers A1 Harm A.W.M. Tiddens A1 Herman Goossens A1 Michael Tunney A1 Felix C. Ringshausen A1 Adam T. Hill A1 Rashidkhan Pathan A1 Gerhild Angyalosi A1 Francesco Blasi A1 Stuart J. Elborn A1 Charles S. Haworth A1 , YR 2021 UL http://erj.ersjournals.com/content/57/1/2001451.abstract AB The study aimed to determine the efficacy of a safe and well-tolerated dose and regimen of tobramycin inhalation powder (TIP) on Pseudomonas aeruginosa sputum density in patients with bronchiectasis.This is a phase II, double-blind, randomised study in bronchiectasis patients aged ≥18 years with chronic P. aeruginosa infection. Patients were randomised 1:1:1 to either cohort A: three capsules of TIP once daily (84 mg); cohort B: five capsules once daily (140 mg) or cohort C: four capsules twice daily (224 mg). Within each cohort, patients were further randomised 2:2:1 either to TIP continuously, TIP cyclically (alternating 28 days of TIP and placebo) or placebo for 16 weeks, respectively and were followed up for 8 weeks.Overall, 107 patients were randomised to cohorts A (n=34), B (n=36) and C (n=37). All three TIP doses significantly reduced the P. aeruginosa sputum density from baseline to day 29 versus placebo in a dose-dependent manner (p≤0.0001, each). A smaller proportion of patients in the continuous-TIP (34.1%) and cyclical-TIP (35.7%) groups experienced pulmonary exacerbations versus placebo (47.6%) and also required fewer anti-pseudomonal antibiotics (38.6% on continuous TIP and 42.9% on cyclical TIP) versus placebo (57.1%) although not statistically significant. Pulmonary exacerbation of bronchiectasis was the most frequent (37.4%) adverse event. Overall, TIP was well tolerated, however, 23.4% of the patients discontinued the study drug due to adverse events.Continuous- and cyclical-TIP regimens with all three doses were safe and effective in reducing the P. aeruginosa sputum density in patients with bronchiectasis and chronic P. aeruginosa infection.Inhaled dry powder tobramycin (TOBI Podhaler) significantly reduced Pseudomonas aeruginosa sputum density and was well tolerated in patients with bronchiectasis https://bit.ly/3hsRQw9