The contribution of galenics to patients’ sensory perception of nasal sprays after nasal surgery – data from a prospective randomized, controlled, double-blind, cross-over, multi-centre study

Abstract

Introduction:Postoperative care after nasal surgery is commonly achieved with nasal sprays. The current study compared two decongesting, wound healing nasal sprays in patients after nasal surgery in order to investigate their sensoric perception. One of the sprays presented a new galenic formulation (nasic® neo, Cassella-med GmbH & Co. KG).Methods:Using a cross-over design, patients who had undergone nasal surgery applied two different nasal sprays during two treatment periods of 4 days each, interrupted by 3 days wash out period. Sensoric perception of the nasal sprays was assessed with the nasal-spray-sensoric-scale. Throughout the study, nasal obstruction was evaluated by patients, and physical examinations, measurements of vital parameters and rhinoscopic examinations were carried out by investigators. Adverse events were documented during the entire study, and following treatment, patients judged the overall preference, efficacy and tolerability of both products.Results:Overall, no significant differences in sum scores of the assessments of the nasal-spray-sensoric-scale were observed between treatments. Significant periodic effect observed during the cross-over study limited the overall analysis. Nevertheless, it could be shown that significantly more patients preferred the new galenics nasal spray compared to the comparator spray (57.1% vs. 34.7%; p=0.031). Further, 10% more patients rated the efficacy of new galenics as ‘good’ to ‘very good’ compared to the comparator. Importantly, a subgroup population of patients with more pronounced signs of inflammation present at screening evaluated the sensoric perception of new galenics significantly better (p=0.033) compared to the comparator. Within this subgroup, no periodic effect was observed. The application of both nasal sprays was shown to be safe and well-tolerated.Conclusion:The current study showed that the overall sensoric perception of both nasal sprays was evaluated comparably well in patients after nasal surgery and that overall, the application of the new galenics nasal spray was preferred by significantly more patients compared to the comparator nasal spray. Patients with marked nasal abnormalities may have a greater benefit from the contribution of galenics as significant differences in the sensoric evaluation by the nasal-spray-sensoric-scale in favour of the new galenics product were shown for this subgroup.Trial registration: The current study was registered in the EU Clinical Trials Register with the EudraCT No: 2019-004936-52.