Noninterventional Open-Label Trial Investigating the Efficacy and Safety of Ectoine Containing Nasal Spray in Comparison with Beclomethasone Nasal Spray in Patients with Allergic Rhinitis

Abstract

Objectives. The current study aimed to compare the efficacy and safety of a classical anti-inflammatory beclomethasone nasal spray in comparison to a physic-chemical stabilizing ectoine containing nasal spray in the treatment of allergic rhinitis. Design and Methods. This was a noninterventional, open-label, observational trial investigating the effects of beclomethasone or ectoine nasal spray on nasal symptoms and quality of life. Over a period of 14 days, patients were asked to daily document their symptoms. Efficacy and tolerability were assessed by both physicians and patients. Results. Both treatments resulted in a significant decrease of TNSS values. An equivalence test could not confirm the noninferiority of ectoine treatment in comparison with beclomethasone treatment. Although clear symptom reduction was achieved with the ectoine products, the efficacy judgment showed possible advantages for the beclomethasone group. Importantly, tolerability results were comparably good in both groups, and a very low number of adverse events supported this observation. Both treatments resulted in a clear improvement in the quality of life as assessed by a questionnaire answered at the beginning and at the end of the trial. Conclusion. Taken together, it was shown that allergic rhinitis can be safely and successfully treated with beclomethasone and also efficacy and safety were shown for ectoine nasal spray.

Alpha-tocopherol acetate nasal spray in the treatment of pollen-induced allergic rhinitis

“…These results are in line with those demonstrated in this NIS. Ectoine-containing nasal spray, however, was shown to be inferior to BNS [28].…”

Ectoine as a promising protective agent in humans and animals

“…Some studies showed that products containing ectoine may be a better alternative to other products, as they reduce ocular and nasal symptoms with no side effects (40)(41)(42). Promising effects such as reduction of nasal airway obstruction and crust formation were also observed in patients with rhinitis sicca anterior treated with nasal spray containing ectoine alone or in combination with dexpanthenol (43). Moreover, a recent study has shown that a mouth and throat spray containing ectoine can be very effective in the treatment of acute pharyngitis and laryngitis (44).…”

Ectoine in the treatment of ocular allergy

“…Ektoina (kwas 1,4,5,6-tetrahydro-2-metylo-4-pyrimidynokarboksylowy) to cząsteczka naturalnie produkowana przez ekstromofile, bakterie żyjące w trudnych warunkach środowiska. Tworzy ona naturalną barierę ochronną przed oddziaływaniem czynników szkodliwych, takich jak wysoka temperatura, promieniowanie ultrafioletowe czy nadmierna suchość [8,9]. Ekstromofile nabywają odporność poprzez zmianę składu lipidów w błonach komórkowy i regulację wewnątrzkomórkowego stężenia substancji rozpuszczonych o niskiej masie cząsteczkowej, takich jak kompatybilny rozpuszczony roztwór ektoiny.…”

“…Ekstromofile nabywają odporność poprzez zmianę składu lipidów w błonach komórkowy i regulację wewnątrzkomórkowego stężenia substancji rozpuszczonych o niskiej masie cząsteczkowej, takich jak kompatybilny rozpuszczony roztwór ektoiny. W badaniach wykazano, że ektoina zapewnia ochronę komórek nabłonkowych, stabilizuje błony komórkowe, nawilża powierzchnię oraz zmniejsza stan zapalny [8][9][10][11][12][13].…”

“…Profile bezpieczeństwa obu leków były porównywalne. Skuteczność steroidu była nieznacznie wyższa niż ektoiny, naturalnej substancji stabilizującej błony komórkowe [9].…”