Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2023 Aug;17(8):748-753.
doi: 10.1111/crj.13663. Epub 2023 Jul 17.

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

Lotte C Terpstra  1 , Daphne van der Geest  1 , Inez Bronsveld  2 , Harry Heijerman  2 , Wim G Boersma  1
Affiliations
Randomized Controlled Trial

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

Lotte C Terpstra et al. Clin Respir J. 2023 Aug.

Abstract

Introduction: Tobramycin 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.

Methods: Fifty-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.

Results: Fifty-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.

Conclusion: The 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.

Keywords: airway hyperresponsiveness; bronchiectasis; side effects; tobramycin inhalation solution; tolerance test.

PubMed Disclaimer

Conflict of interest statement

WGB reported grants paid to his institution from GlaxoSmithKline and reported consulting fee for the Adviesraad 2021. IB and HH reported grants form Longfonds and CF fonds paid to their institution. LCT and DG have nothing to disclose.

References

    1. Polverino E, Goeminne PC, McDonnell MJ, et al. European respiratory society guidelines for the management of adult bronchiectasis. Eur Respir J. 2017;50(3):1700629. doi:10.1183/13993003.00629-2017 - DOI - PubMed
    1. Laska IF, Crichton ML, Shoemark A, Chalmers JD. The efficacy and safety of inhaled antibiotics for the treatment of bronchiectasis in adults: a systematic review and meta‐analysis. Lancet Respir Med. 2019;7(10):855‐869. doi:10.1016/S2213-2600(19)30185-7 - DOI - PubMed
    1. Terpstra LC, Boersma WG. 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. - PMC - PubMed
    1. Brodt AM, Stovold E, Zhang L. Inhaled antibiotics for stable non‐cystic fibrosis bronchiectasis: a systematic review. Eur Respir J. 2014;44(2):382‐393. doi:10.1183/09031936.00018414 - DOI - PubMed
    1. Barker AF, Couch L, Fiel SB, et al. Tobramycin solution for inhalation reduces sputum Pseudomonas aeruginosa density in bronchiectasis. Am J Respir Crit Care Med. 2000;162(2):481‐485. doi:10.1164/ajrccm.162.2.9910086 - DOI - PubMed

Publication types

MeSH terms

Grants and funding