R. Mosges et al., EFFICACY AND TOLERABILITY OF LEVOCABASTINE AND AZELASTINE NASAL SPRAYS FOR THE TREATMENT OF ALLERGIC RHINITIS, Mediators of inflammation, 4, 1995, pp. 11-15
LEVOCABASTINE and azelastine are currently the only antihistamines ava
ilable as nasal sprays for the topical therapy of seasonal allergic rh
initis. The present study was undertaken to compare the onset of actio
n, efficacy and tolerability of these two agents in a total of 242 pat
ients with this condition. This was an international, multicentre, ope
n-label, randomized, parallel-group trial with 123 patients treated wi
th levocabastine (0.5 mg/ml, two puffs per nostril twice daily) and 11
9 with azelastine (1 mg/ml, one puff per nostril twice daily). Onset o
f action was comparable for the two drugs with over 50% of patients hi
each group reporting significant symptomatic relief within 30 min of
administration of the first dose of study medication. Therapeutic effi
cacy was also found to be comparable in the two groups with no statist
ically significant intergroup differences reported for any of the para
meters evaluated, although assessments of global therapeutic efficacy
revealed a trend favouring levocabastine. Levocabastine appeared to be
better tolerated than azelastine (p = 0.06), with the incidence of th
e most common adverse experiences, application site reactions and tast
e disturbances, significantly higher on azelastine than with levocabas
tine (5% versus 1%; p = 0.05 and 5% versus 0%; p = 0.01, respectively)
. In conclusion, levocabastine nasal spray appears to be at least as e
ffective as, but better tolerated than, azelastine nasal spray for the
treatment of seasonal allergic rhinitis.