W. Lassig et al., TOPICAL THERAPY OF ALLERGIC RHINITIS IN CHILDHOOD - ALLERGODIL NASAL SPRAY - NONSEDATING IN CHILDREN, Current medical research and opinion, 13(7), 1996, pp. 391-395
Citations number
4
Categorie Soggetti
Medicine, General & Internal","Medicine, Research & Experimental
The efficacy and safety of the nasally administered drug Allergodil(R)
in the treatment of allergic rhinitis were evaluated in a prospective
drug monitoring programme conducted in Germany. Data from 489 childre
n under the age 13 were included. The study was designed to gain knowl
edge about Allergodil(R) in a normal clinical setting. Dosing was at t
he judgement of the investigator bearing in mind data sheet recommenda
tions, i.e. one spray-puff (0.14 mg) per nostril twice daily. Patients
were treated for four weeks. The occurrence often nasal, eye and thro
at symptoms was rated (0 = never, I = sometimes, 2 = often). All sympt
oms 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 p
atients was very good and good in more than 85% of patients. 70% of pa
tients required no concomitant medication. 13.5% of patients experienc
ed adverse events, mostly mild or moderate in severity. Safety and tol
erance 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 ag
ed 6-12 years. In conclusion, these results suggest that Allergodil(R)
is an effective treatment of the symptoms of allergic rhinitis in chi
ldren. The subgroup of 48 young patients studied shows that Allergodil
(R) was safe and well tolerated in patients aged 2-6 years.