Tolerability and effects on quality of life of liposomal nasal spray treatment compared to nasal ointment containing dexpanthenol or isotonic NaCl spray in patients with rhinitis sicca

Abstract

This study aimed to investigate symptom reduction via the liposomal nasal spray LipoNasal (LN) in patients with rhinitis sicca. Tolerability and the impact on quality of life were also examined. The same parameters were established in parallel for treatment approaches with Bepanthen (BP) nasal ointment containing dexpanthenol and the Rhinomer (RH) nasal spray containing NaCl. This prospective, controlled, open-label observation study was a multicenter trial. 92 patients with rhinitis sicca were allocated to three arms according to their symptoms: LN: n = 33; BP: n = 32 and RH: n = 27. The study comprised three visits at an interval of 14 days. Efficacy was examined by the Rhinitis Sicca Symptom Score (RSSS) documented daily and at the visits based on an endoscopic evaluation. The nasal spray sensory scale was used to investigate the tolerability. Quality of life (QoL) was measured by means of the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and the “Short Form 12” of the “Impact on Health-Related Quality of Life (HRQL)” questionnaire on general quality of life. Nasal symptoms improved significantly (p = 0.001) under all three treatment approaches, reflected by the reduction in the RSSS and the Endoscopy Sum Score. A comparison of the three groups showed that no therapy was significantly superior to any of the others (p = 0.410). The tolerability of all treatments was good. Concerning the nasal moisturization, LipoNasal was evaluated better than Bepanthen and Rhinomer. Quality of life improved in all groups, but not significantly. The results show good efficacy and tolerability of the liposomal nasal spray compared to generally recognized treatments of rhinitis sicca with dexpanthenol nasal ointment and NaCl nasal spray. LipoNasal therefore constitutes a good treatment for patients suffering from dry nose.

Randomised trial on performance, safety and clinical benefit of hyaluronic acid, hyaluronic acid plus dexpanthenol and isotonic saline nasal sprays in patients suffering from dry nose symptoms

“…The randomised design, the inclusion of several study centres throughout Germany and the study conduction over a period of one year should have limited seasonal and regional factors, however. Taking a closer look at the previously performed studies cited above, it becomes apparent that out of these four trials, only Hahn et al [34] evaluated an isotonic saline solution based on seawater, meanwhile Kehrl and Sonnemann [37] , Oysu et al [38] and Johnsen et al [39] compared the effects of isotonic sodium chloride solutions versus other nasal products. Meanwhile Hahn et al reported positive results for the saline solution tested, the latter three authors observed poor effects.…”

“…Secondary endpoints: Clinical symptoms recorded for assessment of the primary endpoint were also evaluated as single items for each nasal spray. Furthermore, a sum score was built from parameters dry nose, impairment of nasal breathing/nasal obstruction and crusting in accordance to a recent publication [34] .…”

“…The Rhinitis Sicca Symptom Scores (RSSS) for the initial and final examination are given in Fig. 2 Significant improvements were also observed when dry nose, impairment of nasal breathing/nasal obstruction and crusting were evaluated as sum score according to the publication of Hahn et al [34] (data not shown). Furthermore, all single items of the clinical symptoms recorded for assessment of the primary endpoint improved significantly for each nasal spray when initial and outcome values were compared ( p < 0.010).…”

Dexpanthenol: An Overview of its Contribution to Symptom Relief in Acute Rhinitis Treated with Decongestant Nasal Sprays

“…Therefore, it is not surprising that alternatives to the alpha-sympathomimetic drugs have been sought for a long time. Our group thoroughly investigated the effects and the tolerability of liposomal nasal sprays and ectoine-containing nasal sprays in several clinical trials [ 21 , 30 – 35 ]. We found that both preparations were comparably effective and low in side effects.…”

“…The same superiority was found for nasal irritation, and the recovery time was significantly reduced by about 40%, which appears to be a clinically relevant reduction. Comparing a liposomal nasal spray with an ointment containing dexpanthenol but no decongestant and with an isotonic sodium chloride spray in rhinitis sicca patients, Hahn et al found that, concerning the nasal moisturization, the liposomal spray was evaluated better than dexpanthenol and the isotonic spray [ 21 ]. We reckon that the efficacy and tolerability of a liposomal spray is good compared to generally recognized treatments of rhinitis sicca with nasal ointments containing dexpanthenol alone and with isotonic nasal sprays.…”