The efficacy and safety of a new
antiallergic drug, intranasal
azelastine (CAS 58581-89-8), in the treatment of
seasonal allergic rhinitis was investigated in a 16 patient double-blind comparison with placebo and another 36 patient open comparison with
budesonide (CAS 51333-22-3). Efficacy was assessed in terms of 13 signs and symptoms of
allergic rhinitis and tolerability on the basis of spontaneously reported adverse events. In the first study, compared to placebo a one week's treatment with
azelastine resulted in substantial relief of
sneezing (p = 0.009), nasal
itching (p = 0.009), swelling of the nasal mucosa (p = 0.067) and rhinorrhoea (p = 0.262) in patients having the above symptoms at baseline of at least moderate to severe intensity. According to the judgement of the supervising physician, 7/8
azelastine-treated patients but none receiving placebo responded well to
therapy (p = 0.001). In the second study a two weeks' treatment with intranasal
azelastine was found not to differ significantly from
budesonide 67% of patients showed improvement in principal signs of
rhinitis after one week's
therapy irrespective of treatment. Nasal symptoms, including
nasal obstruction, were most markedly improved by both treatments.
Azelastine, but not
budesonide, also relieved ocular symptoms associated with
rhinitis. Adverse events did not occur more frequently under
azelastine than under placebo treatment and were often of uncertain relationship to treatment.