Inhaled Nebulized Tobramycin in Non-cystic Fibrosis Bronchiectasis

Summary

The purpose of this study is to evaluate the effect of tobramycin inhalation solution (TIS) once daily compared tot placebo in patients with non-CF bronchiectasis. The primary endpoint is a reduction of exacerbations of the disease during the treatment period. Next to this parameter the investigators expect to show a significant beneficial effect on lung function parameters, QoL, bacterial load of pathogens in sputum and tobramycin resistance.

Timeline

Start

2016-08-13

Primary completion

2019-12-13

Completion

2019-12-13

Publications

• Terpstra LC, Altenburg J, Bronsveld I, Doodeman HJ, Rozemeijer W, Heijerman HGM, Boersma WG. The BATTLE study: Effects of long-term tobramycin inhalation solution (TIS) once daily on exacerbation rate in patients with non-cystic fibrosis bronchiectasis. Study protocol of a double blind, randomized, placebo-controlled trial: study protocol. Contemp Clin Trials Commun. 2022 Dec 6;30:101045. doi: 10.1016/j.conctc.2022.101045. eCollection 2022 Dec.
• Terpstra LC, Altenburg J, Bronsveld I, de Kruif MD, Berk Y, Snijders D, Rozemeijer W, Heijerman HGM, Boersma WG. Effects of long-term tobramycin inhalation solution (TIS) once daily on exacerbation rate in patients with non-cystic fibrosis bronchiectasis. Respir Res. 2022 Dec 3;23(1):330. doi: 10.1186/s12931-022-02243-y.

Drugs

Indications