Efficacy and safety of TOBI Podhaler® in Pseudomonas aeruginosa-infected bronchiectasis patients: iBEST study
Articolo
Data di Pubblicazione:
2020
Citazione:
Efficacy and safety of TOBI Podhaler® in Pseudomonas aeruginosa-infected bronchiectasis patients: iBEST study / M.R. Loebinger, E. Polverino, J.D. Chalmers, H.A.W.M. Tiddens, H. Goossens, M. Tunney, F.C. Ringhausen, A.T. Hill, R. Pathan, G. Angyalosi, F. Blasi, S.J. Elborn, C.S. Haworth. - In: EUROPEAN RESPIRATORY JOURNAL. - ISSN 0903-1936. - (2020). [Epub ahead of print] [10.1183/13993003.01451-2020]
Abstract:
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≤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 BE was the most frequent (37.4%) adverse event (AE). Overall, TIP was well tolerated, however, 23.4% of the patients discontinued the study drug due to AEs.
Conclusion: Continuous- and cyclical-TIP regimens with all three doses were safe and effective in reducing the Pa sputum density in patients with BE and chronic Pa infection.
Tipologia IRIS:
01 - Articolo su periodico
Elenco autori:
M.R. Loebinger, E. Polverino, J.D. Chalmers, H.A.W.M. Tiddens, H. Goossens, M. Tunney, F.C. Ringhausen, A.T. Hill, R. Pathan, G. Angyalosi, F. Blasi, S.J. Elborn, C.S. Haworth
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