Late Breaking Abstract - Effects of long-term Tobramycin Inhalation Solution (TIS) once daily on exacerbation rate in patients with non-cystic fibrosis bronchiectasis. The BATTLE Randomized Controlled Trial

<b>Background:</b> Long-term inhaled antibiotics are the standard care in CF-bronchiectasis. However, in non-CF bronchiectasis, studies are limited, particularly with tobramycin inhalation solution (TIS). We investigated the efficacy and safety of maintenance TIS in bronchiectasis patients colonized by different pathogens sensitive for tobramycin. The primary endpoint of the study was a 50% reduction in number of exacerbations using TIS as compared to placebo. Secondary endpoints were time to next exacerbation, change in lung function, QoL, sputum density and safety. <b>Study design:</b> The BATTLE study is a randomized, double blind placebo controlled, multicenter trial in patients aged ≥ 18-year-old with confirmed bronchiectasis, at least two exacerbations in the preceding year, and a positive sputum culture. Patients were treated with TIS OD or placebo (saline 0.9%) for 1 year followed by a run-out period. <b>Results:</b> 58 patients were included (figure 1). A non-significant decrease in number of exacerbations in patients treated with TIS (before 3.81 vs. after 1.58) as compared to placebo (before 3.85 vs. after 2.23) was found in the mITT-population (<i>p</i>=0.147), with a risk reduction of 26% for TIS. Time to next exacerbation in weeks differed, with a hazard ratio of 0.64 (95% CI 0.35-1.19) for patients receiving TIS (figure 2). Results of the other secondary endpoints will be evaluated later. <b>Discussion:</b> Although the primairy endpoint was not significantly reached, our results showed that TIS OD is a treatment option for the frequent exacerbating bronchiectasis patients infected by different pathogens.