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Multicenter Study
. 2022 Dec 3;23(1):330.
doi: 10.1186/s12931-022-02243-y.

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

Lotte C Terpstra  1 , Josje Altenburg  2 , Inez Bronsveld  3 , Martijn D de Kruif  4 , Yvonne Berk  5 , Dominic Snijders  6 , Wouter Rozemeijer  7 , Harry G M Heijerman  3 , Wim G Boersma  8
Affiliations
Multicenter Study

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

Lotte C Terpstra et al. Respir Res. .

Abstract

Background: Use 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.

Objective: The 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/patients: IN 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.: RESULTS: 58 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.

Conclusion: Long-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.

Keywords: Bronchiectasis; Exacerbations; Tobramycin inhalation solution.

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Conflict of interest statement

WGB received an unrestricted grant from TEVA pharmaceutics and TIS was supplied by TEVA pharmaceutics. The other authors have no competing interest.

Figures

Fig. 1
Fig. 1
Study flow chart. TIS Tobramycin inhalation solution, ITT Intention to treat population; mITT modified intention to treat population, PP per protocol population, Patients were screened in 6 hospitals
Fig. 2
Fig. 2
Time to next exacerbation. Kaplan Meier plot of time to fist exacerbation in the mITT population; X-axis: Time in weeks. Y-axis: Percentage of exacerbation free patients. Hazard ratio: 0.64 (95% CI 0.35–1.19)
See this image and copyright information in PMC

References

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