Abstract | Background: Objective: Study design: The BATTLE study is a randomized, double blind placebo controlled, multicenter study in the Netherlands performed in patients aged ≥18-year-old with confirmed bronchiectasis, at least two exacerbations in the preceding year, and minimal one positive sputum culture with gram negative pathogens or Staphylococcus aureus, sensitive to tobramycin in the preceding year and at baseline. Patients will be treated with TIS once daily (OD) or placebo ( saline 0.9%) OD for 52 weeks followed by a run-out period of 4 weeks after the last dose. The primary outcome is the yearly rate of pulmonary exacerbations. Among secondary outcome parameters are time to exacerbation, lung function, QoL, microbiological evaluation and safety. Discussion: The BATTLE study is designed to determine the efficacy and safety of maintenance TIS OD in bronchiectasis patients colonized by different pathogens and could lead to important new evidence for TIS therapy in this population.The BATTLE study is registered in Clinical trials.gov with registration number: NCT02657473.
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Authors | L C Terpstra, J Altenburg, I Bronsveld, H J Doodeman, W Rozemeijer, H G M Heijerman, W G Boersma |
Journal | Contemporary clinical trials communications
(Contemp Clin Trials Commun)
Vol. 30
Pg. 101045
(Dec 2022)
ISSN: 2451-8654 [Electronic] Netherlands |
PMID | 36531900
(Publication Type: Journal Article)
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Copyright | © 2022 The Authors. |