Ac. Negrini et al., ORAL ANTIHISTAMINE DECONGESTANT TREATMENT COMPARED WITH INTRANASAL CORTICOSTEROIDS IN SEASONAL ALLERGIC RHINITIS, Clinical and experimental allergy, 25(1), 1995, pp. 60-65
This international, multicentre, randomized, double-blind, double-dumm
y, parallel-group trial was undertaken to compare the efficacy and tol
erability of once-daily astemizole-D (10 mg astemizole plus 240 mg pse
udoephedrine) with beclomethasone nasal spray (0.05 mg/ml) two puffs/n
ostril administered twice daily in a total of 204 patients with season
al allergic rhinitis. Treatment duration was 4 weeks. Although investi
gator assessments of symptom severity were generally comparable in the
two treatment groups throughout the trial, statistically significant
differences in favour of astemizole-D for sneezing and ocular symptoms
were apparent at the end of the 4-week treatment period (P < 0.05). P
atient diary data support these findings, with significant differences
in favour of the antihistamine/decongestant combination reported for
ocular symptoms after 2 weeks of treatment (P < 0.05) and non-signific
ant trends for sneezing after 2 weeks and ocular symptoms over the ent
ire treatment period (P = 0.07). Use of rescue medication for ocular s
ymptoms was also significantly lower in the astemizole-D treatment gro
up (P < 0.05). A wide range of adverse experiences were reported, howe
ver, there were no statistically significant differences in the type o
r incidence of those between the two treatment groups. In conclusion,
astemizole-D appears to be at least as effective and well tolerated as
intranasal beclomethasone in the treatment of seasonal allergic rhini
tis, providing at least comparable relief from all nasal symptoms incl
uding congestion and significantly greater relief from ocular symptoms
than the topical steroid.