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

Terpstra, Lotte; Bronsveld, Inez; Doodeman, Jeroen; Rozenmeijer, Wouter; Heijerman, H.G.M.; Boersma, Wim

doi:10.1183/13993003.congress-2020.4134

Cited by 2 publications

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“…However, possible side effects of the use of inhaled TIS are chronic cough and bronchospasm, which have been reported in up to 70% of patients treated with TIS in previous studies 5–7 . However, data on the respiratory adverse events were not consistent, and in contrast to these studies, two recent conducted randomized controlled trials (RCTs) observed no significant bronchial hyperreactivity after the use of TIS 3,8 . In addition, no significant increase in the development of bronchospasms was found in a recent published meta‐analysis, whereby RCTs were included with TIS as well as other variants of inhaled antibiotics 2 .…”

Section: Introductionmentioning

confidence: 98%

“…[5][6][7] However, data on the respiratory adverse events were not consistent, and in contrast to these studies, two recent conducted randomized controlled trials (RCTs) observed no significant bronchial hyperreactivity after the use of TIS. 3,8 In addition, no significant increase in the development of bronchospasms was found in a recent published meta-analysis, whereby RCTs were included with TIS as well as other variants of inhaled antibiotics. 2 Because of the lack of consistent data, our current available guidelines suggest a clinical (in hospital) tolerance test with the first dose of the inhaled antibiotics to observe the possible occurrence of bronchospasm.…”

Section: Introductionmentioning

confidence: 99%

“…1 Long-term inhaled antibiotics are recommended for the frequent exacerbating bronchiectasis patients, with additional evidence for treatment with tobramycin inhalation solution (TIS). [1][2][3] The inhaled administration of antibiotics can provide a consistent deposition of high antibiotic concentrations directly to the side of infection, with a lower risk of toxicity or systemic adverse events. 2,4 However, possible side effects of the use of inhaled TIS are chronic cough and bronchospasm, which have been reported in up to 70% of patients treated with TIS in previous studies.…”

Section: Introductionmentioning

confidence: 99%

“…Bronchiectasis is characterized by the presence of dilated bronchi and chronic inflammation, which leads to persistent coughing and sputum production with recurrent exacerbations 1 . Long‐term inhaled antibiotics are recommended for the frequent exacerbating bronchiectasis patients, with additional evidence for treatment with tobramycin inhalation solution (TIS) 1–3 . The inhaled administration of antibiotics can provide a consistent deposition of high antibiotic concentrations directly to the side of infection, with a lower risk of toxicity or systemic adverse events 2,4 .…”

Section: Introductionmentioning

confidence: 99%

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Treatment with inhaled antibiotics in bronchiectasis, side effects, and evaluation of the tolerance test; analysis from the BATTLE randomized controlled trial

Terpstra,

van der Geest,

Bronsveld

et al. 2023

Clinical Respiratory J

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IntroductionTobramycin inhalation solution (TIS) is a treatment option for patients with frequent exacerbations of bronchiectasis. A possible side effect of TIS is the development of chronic cough and bronchospasm, whereby the guidelines suggest a (in hospital) tolerance test with the first dose of TIS. However, data on respiratory adverse events are not consistent. In the present analysis from the BATTLE study (NCT02657473), we evaluated the added value of the tolerance test and aimed to observe the development of inhaled treatment related bronchial hyperreactivity.MethodsFifty‐seven patients from the BATTLE study were analyzed. Patients were randomized to receive TIS or placebo OD for 1 year. A tolerance test was performed with spirometry measurements before and after the first dose and with a bronchodilator in advance. Adverse events were strictly monitored.ResultsFifty‐seven patients (100%) passed the tolerance test with no decrease in spirometry measurements or development of local intolerability. During the study treatment, a total of five TIS‐treated patients (17.8%) withdrew due to airway hyperresponsiveness after a mean of 9.2 (SD13.9) weeks and one placebo‐treated patient (3.5%) after 2 weeks (TIS vs. placebo; p = 0.66). The other TIS‐related adverse events were not clinically significant.ConclusionThe use of inhaled medication is well tolerated in the heterogenous bronchiectasis population, without signs of airway hyperresponsiveness after the first dose of inhaled medication. From this observation, it can be concluded that there is no additional value for this advised tolerance test. However, closely monitoring on adverse effects during the first weeks after starting TIS is recommended.

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Section: Introductionmentioning

confidence: 98%