INTRODUCTION: The study aimed to determine the efficacy of a safe and well-tolerated dose and regimen of tobramycin inhalation powder (TIP) on Pseudomonas aeruginosa (Pa) sputum density in patients with bronchiectasis (BE). METHODS: This is a phase II, double-blind, randomised study in BE patients aged >/=18 years with chronic Pa infection. Patients were randomised 1:1:1 to either Cohort A: 3 capsules of TIP O.D. (84 mg); Cohort B: 5 capsules O.D. (140 mg) or Cohort C: 4 capsules B.I.D. (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. RESULTS: Overall, 107 patients were randomised to Cohorts A (n=34), B (n=36) and C (n=37). All three TIP doses significantly reduced the Pa sputum density from baseline to Day 29 versus placebo in a dose-dependent manner (p
Loebinger, M. R.
Polverino, E.
Chalmers, J. D.
Tiddens, Hawm
Goossens, H.
Tunney, M.
Ringshausen, F. C.
Hill, A. T.
Pathan, R.
Angyalosi, G.
Blasi, F.
Elborn, S. J.
Haworth, C. S.
i, Best-Trial Team
