Current Medical Research and Opinion (1996), 13, No. 7, 391-395

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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
A. Roloff5

1Paediatric Clinic, Halle Regional Hospital, 2,3Institute of Clinical Research, MIM, Munich, 4,5 ASTA Medica, Frankfurt am Main, Germany

Accepted: 26th March 1996

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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.

Key Words

Allergodil® - Allergic rhinitis - Nasal spray - Clinical study - Children


Various epidemiological studies show that an increasing number of children suffer from allergic disorders. These manifest themselves frequently as allergic rhinitis, the prevalence of which may amount to approximately 18% in children below 13 years of age.1, 2

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

Patients and methods

In a multicentre observation the efficacy and tolerability of Allergodil® nasal spray was studied in patients suffering from allergic rhinitis.


During a period of observation from February to November 1992 a total of 4018 patients was included in the investigation. The results described below refer to 489 children of up to 12 years of age who were treated in approximately 200 medical practices. In 21.5% of these children, rhinitis was diagnosed as 'perennial', and in 67.7% as 'seasonal'. 7.9% exhibited a 'mixed' form.


The incidences of ten clinical symptoms of allergic rhinitis were assessed prior to therapy, as well as after two and four weeks of treatment. Parameters studied were:


In 89% of all cases the administered dose of Allergodil® was two sprays per nostril per day, corresponding with the recommended daily dosage of 2 × 0.14 mg azelastine.

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%).



All ten clinical symptoms underwent a statistically significant and clinically relevant reduction during the four week treatment period (p < 0.05; see Table I). Based on symptom scores, most of the 352 patients with complete data demonstrated a decrease in symptoms (97.4%), whereas only a small number of patients showed no change (1.4%) or an increase in symptoms (1.1%).

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.

Table I.
Symptoms of allergic rhinitis prior to and after four weeks of treatment with Allergodil® nasal spray (as %)


At the end of treatment the following aspects were judged as 'very good' or 'good' by physicians and patients (see Table II).

Table II
Therapeutic efficacy (as %)
Physician's assessment
Patient's assessment
Therapeutic efficacy
Systemic tolerance
Local tolerance

According to the physicians the most impressive results of treatment with Allergodil® nasal spray were:

Adverse events

Adverse events occurred in 13.5% of patients. The most frequent of these were:

In most instances the adverse events were tolerable, leading to premature discontinuation of treatment in only 3.5% of cases.


The results of this multicentre study of the use of Allergodil® nasal spray clearly demonstrate an improvement of symptoms in patients up to 12 years of age with seasonal and perennial rhinitis. These results are confirmed by the favourable assessments of efficacy and tolerance on the part of both patients and participating physicians.

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.


1. Nowok, K., (1993). Zur Epidemiologie allergischer Erkrankungen: Betrachtungen anläßlich einer multizentrischen Andwendungsbeobachtung mit einem Antihistaminikum bei pädiatern. Sozialpädiatrie, 15(3), 192-193.

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.