Topical therapy of allergic rhinitis in childhood: Allergodil nasal spray -non-sedating in children

Abstract

The efficacy and safety of the nasally administered drug Allergodil in the treatment of allergic rhinitis were evaluated in a prospective drug monitoring programme conducted in Germany. Data from 489 children under the age 13 were included. The study was designed to gain knowledge about Allergodil in a normal clinical setting. Dosing was at the judgement of the investigator bearing in mind data sheet recommendations, i.e. one spray-puff (0.14 mg) per nostril twice daily. Patients were treated for four weeks. The occurrence of ten nasal, eye and throat symptoms was rated (0 = never, 1 = sometimes, 2 = often). All symptoms showed a statistically significant improvement at the final visit, as did the overall sums of the scores. These changes were clinically significant. Overall assessment of efficacy by the physicians and the patients was very good and good in more than 85% of patients. 70% of patients required no concomitant medication. 13.5% of patients experienced adverse events, mostly mild or moderate in severity. Safety and tolerance were assessed as very good and good in more than 97% of cases. No sedation was seen. With respect to both efficacy and safety, there were no differences between patients younger than 6 years and those aged 6-12 years. In conclusion, these results suggest that Allergodil is an effective treatment of the symptoms of allergic rhinitis in children. The subgroup of 48 young patients studied shows that Allergodil was safe and well tolerated in patients aged 2-6 years.

Comparative Efficacy and Safety of Azelastine and Levocabastine Nasal Sprays in Patients with Seasonal Allergic Rhinitis

“…In animal models azelastine has shown to have only poor access to the CNS [14,15]. In clinical studies with azelastine sedation was slightly more frequently reported than after placebo [16−19], whereas in other trials sedation was not reported at all [20,21]. On the other hand, somnolence and fatigue have been reported as two of the most commonly occurring adverse events with intranasal levocabastine [6].…”

New aspects of the Slug Mucosal Irritation assay: predicting nasal stinging, itching and burning sensations

“…Generally, azelastine HCl is well tolerated; however some commonly reported adverse events associated with the use of intranasal azelastine include irritation of the nasal mucosa and application site (e.g. Grossman et al ., 1994; Lassig et al ., 1996; Mösges et al ., 1995; Wober et al ., 1997), and nasal burning (e.g. Lumry et al ., 2007; Newson‐Smith et al ., 1997; Table 6).…”

Allergic rhinitis in children

“…In addition to its ability to relieve sneezing; postnasal drip; rhinorrhea; cough; conjunctival symptoms; and itching of the nose, eyes, ears, throat, and palate in 93% of patients between 6 and 11 years of age as a consequence of its histamine antagonism, it also is able to reduce the influx of inflammatory cells into the nasal mucosa and block the release of several mediators [43,44]. Two are now available, levocabastine and azelastine, both of which possess anti-inflammatory activities.…”