146 Sinonasal inhalation of isotonic vs. hypertonic saline (6.0%) in CF patients with chronic rhinosinusitis – results of a multicentre, double-blind, controlled prospective trial

Abstract

Objectives Chronic rhinosinusitis significantly impairs CF patients' quality of life. The PariSinus™ device effectively delivers vibrating aerosols to paranasal sinuses. Previously, we demonstrated a significant reduction of sinonasal symptoms by inhalation of dornase alfa with the device (JCF 2014). Bronchially inhaled hypertonic saline (3–7%) was shown to reduce pulmonary symptoms and exacerbations in CF. Aims of this multicentre, double-blind, controlled, crossover trial were to assess effects of hypertonic (6%) and isotonic saline on sinonasal outcome measures. Methods 69 CF patients were randomised to inhale either hypertonic or isotonic saline for 28 days with the PariSinus™. After 28 days of wash-out patients crossed over to the alternative treatment. The primary outcome parameter was upper airway symptoms / disease-specific QoL (Sino-Nasal Outcome Test-20 – SNOT-20). Results Sinonasal inhalation of isotonic and hypertonic saline was well tolerated. Both arms showed slight but not significant reductions of SNOT-20 scores (6% –3.1±6.5pts/0.9% –5.1±8.3pts). Interestingly, a post-hoc analysis of the single therapeutic periods revealed a significant improvement, especially for isotonic saline. We additionally present changes in rhinoscopy, rhinomanometry, and cytokines in nasal lavage. Conclusion Compared to sinonasal inhalation with dornase alfa, effects of isotonic and hypertonic saline on sinonasal symptoms did not reach significance. Possibly, SNOT-20 is not the best outcome parameter for therapy with hypertonic saline due to irritating properties, even if patients reported effective mobilization of mucus, which is difficult to quantify in both airway levels.