Current Medical Research and Opinion (1996), 13, No. 7, 391-395
Topical therapy of allergic rhinitis in childhood:
Allergodil nasal spray - non-sedating in children
W. Lassig,1 Dr Med
W. Wober,2 Dr Med, Dr Rer Nat
C. Höflich,3 PhD
M. Bähre,4 Dr Med
Accepted: 26th March 1996
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.
Desensitisation should be aimed for if possible. However, in most cases, symptomatic treatment of young patients will be adequate. Of particular importance is an effective and well tolerated treatment with as low as possible exposure to an active principle which does not have any sedative side-effects.
Allergodil® nasal spray is a topically administered H1-antihistaminic agent which appears to be suitable for the treatment of children since, when administered as a daily dose of 0.56 mg azelastine, the exposure to the active principle is low even when taking the drug for one month.3, 4
67.9% of the patients did not require any concomitant medication. Only 19.8% received additional medication. Additional drugs employed most frequently were antiasthmatics (13.1%), ophthalmological preparations (9.2%) and antiallergic agents (8.6%).
The total sample also included 48 children below 6 years of age. A separate evaluation of these patients did not yield any noticeable differences when compared with the group of children between 6 and 12 years of age. Only the eye symptoms showed a slightly higher rate of improvement.
In only 1.8% of patients had treatment to be discontinued due to lack of efficacy.
According to the physicians the most impressive results of treatment with Allergodil® nasal spray were:
In most instances the adverse events were tolerable, leading to premature discontinuation of treatment in only 3.5% of cases.
Although in Germany administration of Allergodil® is restricted to patients over 6 years of age, children below 6 years have been treated with this medication as has been documented in this study. Efficacy and tolerance appear to be as good in this age group as in the case of older children.
The most impressive result, referred to by 71.4% of the participating physicians, is that during treatment with Allergodil® nasal spray, no sedative effect was observed. This is of particular importance in the treatment of pre-school and school children.
In view of these results, Allergodil<® nasal spray is considered to be very well suited to the treatment of allergic rhinitis in juvenile patients.
2. Von Mutius, E., Dold, S., Wjst, M., et al., (1991). Münchener Asthma-und Allergiestudie: Prävalenzen atopischer und asthmatischer Erkrankungen in Kindesalter in Bayern. Münch. med. Wschr., 133(45), 675-679.
3. Dorow, P., Aurich, R., and Oetzold, U., (1993). Efficacy and tolerability of azelastine nasal spray in patients with allergic rhinitis compared to placebo and budesonide. Arzneim-Forsch/Drug Res., 43(8), 909-911.
4. Gastpar, H., Aurich, R., Petzold, U., et al., (1993). Azelastine nasal spray for topical treatment of allergic rhinopathy. Atemw. Lungenkrkh. Jahrgang, 19(4), 148-154.