Effects of long-term tobramycin inhalation solution (TIS) once daily on exacerbation rate in patients with non-cystic fibrosis bronchiectasis

Respiratory Research

Research

Wouter Rozemeijer¹  Josje Altenburg²  Yvonne Berk³  Lotte C. Terpstra⁴  Wim G. Boersma⁴  Dominic Snijders⁵  Inez Bronsveld⁶  Harry G. M. Heijerman⁶  Martijn D. de Kruif⁷ 

[1] Department of Medical Microbiology, Northwest Clinics, Alkmaar, The Netherlands;Department of Pulmonary Diseases, Amsterdam Medical Center, Amsterdam, The Netherlands;Department of Pulmonary Diseases, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands;Department of Pulmonary Diseases, Northwest Clinics, Wilhelminalaan 12, 1815 JD, Alkmaar, The Netherlands;Department of Pulmonary Diseases, Spaarne Gasthuis, Hoofddorp, The Netherlands;Department of Pulmonary Diseases, Utrecht University, Utrecht, The Netherlands;Department of Pulmonary Diseases, Zuyderland Medical Center, Heerlen, The Netherlands;

关键词: Bronchiectasis;    Tobramycin inhalation solution;    Exacerbations;   

DOI  :  10.1186/s12931-022-02243-y

 received in 2022-05-24, accepted in 2022-11-06,  发布年份 2022

来源: Springer

【 摘 要 】

BackgroundUse of long-term tobramycin inhalation solution (TIS) has been shown beneficial in cystic fibrosis (CF) and earlier findings also suggest a benefit in non-CF bronchiectasis. We investigated the efficacy and safety of maintenance TIS once daily (OD) in frequent exacerbating bronchiectasis patients chronically infected by different pathogens sensitive for tobramycin.ObjectiveThe primary outcome was the frequency of exacerbations during the 12-month study period. Secondary outcomes were time to first exacerbation, change in lung function and quality of life (QoL), bacterial analysis and safety.Materials/patientsIn this multicenter RCT patients aged ≥ 18-year-old were included with confirmed bronchiectasis and ≥ 2 exacerbations in the preceding year. Patients were assigned (1:1) to receive TIS or placebo OD for 1-year.Results58 patients were included of which 52 were analyzed in the mITT analysis. TIS reduced exacerbation frequency with a RR of 0.74 (95% CI 0.49–1.14) (p = 0.15). Within the TIS population a decrease in number of exacerbations was found (2; p = 0.00), which was also seen in the placebo-treated patients (1.5; p = 0.00). In the TIS-treated patients the QoL improved (LRTI-VAS p = 0.02 Leicester Cough p = 0.02) without additional safety concerns. No differences were found for the other secondary outcomes.ConclusionLong-term TIS OD is a safe treatment modality and showed a non-significant reduced exacerbation frequency of 0.74 as compared to placebo in bronchiectasis patients chronically infected by tobramycin sensitive pathogens. TIS OD may be a potential therapeutic strategy in selected patients with bronchiectasis suffering from a high burden of disease.Trail registration number: The BATTLE study was registered at Clinical trials.gov number: NCT02657473. Date: 13 august 2016.

【 授权许可】

CC BY   
© The Author(s) 2022

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