Abstract
Introduction: Asthma exacerbations (AE) are the major cause of asthma mortality. Bacterial lysates (BL) are known for their positive effect on recurrent respiratory tract infections (RTI).
BL therapy in asthma mouse models resulted in reduced allergic airway inflammation and reduced T helper2 cells, IL-4 and IL-13 production and serum IgE, as well as increased regulatory T cells. In humans, reduction of childhood wheezing and short-term prevention of AE are seen, with a decrease in serum IgE, IL-4 and IL-13. These findings suggest BL could be of clinical relevance in AE-prevention.
To gain more insight into the effects of BL in asthma we initiated a study addressing clinical, microbiological and immunological aspects.
Methods: This double-blind RCT includes patients with severe asthma (SA), GINA4, who experienced ≥ 2 doctordiagnosed AE in the prior year. The intervention consists of Broncho-Vaxom or placebo during 2 winters for 10 consequent days monthly. The primary endpoint, number of AE, will be measured 18 months after study enrollment. Secondary endpoints are: viral RTI; microbiome; pulmonary function; QoL; medication/healthcare use; serum T-cell subset and ILC2-counts/activity; cytokines.
Results: 9 patients are included. No differences between atopic and nonatopic patients were seen in AE-frequency at baseline. In the group started in 2016 (N=20) after one year the no. of AE decreased from 2.5 to 0.94 AE/y (p=0.002). Deblinding follows in 2019.
Conclusion: L could be effective in the prevention of AE. Small clinical studies show positive effects; animal models show decreased allergic airway inflammation. The Breathe study is the first large RCT evaluating BL in patients with SA.
Footnotes
Cite this article as: European Respiratory Journal 2018 52: Suppl. 62, PA5008.
This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).
- Copyright ©the authors 2018