Universität zu Köln

Bergmann, Christoph, Lander, Jennifer, Radtke, Lea, England, Laura, Singh, Jaswinder and Moesges, Ralph (2021). The Contribution of Galenics to Patients' Sensory Perception of Nasal Sprays After Nasal Surgery: Data from a Prospective Randomised, Controlled, Double-Blind, Crossover, Multicentre Study. Adv. Ther., 38 (12). S. 5829 - 5844. NEW YORK: SPRINGER. ISSN 1865-8652

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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 sensory perception. One of the sprays was a new galenic formulation (nasic(R) neo, Cassella-med GmbH & Co. KG). Methods According to the crossover design, patients who had undergone nasal surgery applied two different nasal sprays during two treatment periods of 4 days each, interrupted by a 3-day washout period. Sensory 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. A significant period effect observed during the crossover study limited the overall analysis. Nevertheless, 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 the 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 sensory perception of the new galenics as significantly better (p = 0.033) compared to the comparator. Within this subgroup, no period effect was observed. The application of both nasal sprays was shown to be safe and well-tolerated. Conclusion The overall sensory perception of both nasal sprays was evaluated comparably well in patients after nasal surgery and 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 sensory evaluation by the nasal spray sensoric scale in favour of the new galenics product were shown for this subgroup.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Bergmann, Christoph UNSPECIFIED UNSPECIFIED UNSPECIFIED Lander, Jennifer UNSPECIFIED UNSPECIFIED UNSPECIFIED Radtke, Lea UNSPECIFIED UNSPECIFIED UNSPECIFIED England, Laura UNSPECIFIED UNSPECIFIED UNSPECIFIED Singh, Jaswinder UNSPECIFIED UNSPECIFIED UNSPECIFIED Moesges, Ralph UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-585079
DOI:	10.1007/s12325-021-01937-x
Journal or Publication Title:	Adv. Ther.
Volume:	38
Number:	12
Page Range:	S. 5829 - 5844
Date:	2021
Publisher:	SPRINGER
Place of Publication:	NEW YORK
ISSN:	1865-8652
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language XYLOMETAZOLINE-DEXPANTHENOL; ACUTE RHINITIS; SAFETY Multiple languages Medicine, Research & Experimental; Pharmacology & Pharmacy Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/58507