A double-blind, randomized, parallel-group, placebo-controlled study involving 130 patients was conducted at 9 centres in the U.K. to assess the effect of 6 weeks of treatment with
azelastine nasal spray (
azelastine) and
beclomethasone dipropionate nasal spray (BDP) on the symptoms of perennial
rhinitis. Efficacy was assessed by patients recording daily the severity of the symptoms of
rhinitis on 10-cm visual analogue scales. Analysis of this diary data showed significant reductions in
sneezing, blocked nose, running nose, and
itching nose during
azelastine treatment. Patients on BDP recorded a consistent reduction in
rhinitis symptoms, but these reductions were significant only for
sneezing on treatment day 7. When
rhinitis symptoms were assessed by clinical investigators on a 4-point scale, the scores obtained following treatment with the 2 study medications showed little change from baseline or "active" treatment scores. There was no evidence of a consistent change in nasal airway resistance, measured using anterior rhinomanometry, following treatment with either BDP or
azelastine.
Azelastine nasal spray and BDP
nasal spray were well tolerated by the patients and the relative incidence of adverse events was similar in the
azelastine and placebo/
azelastine treatment groups, except that taste perversion occurred more frequently during
azelastine treatment than during placebo/
azelastine treatment. There was no evidence of an increased incidence of
somnolence or
fatigue in patients who received
azelastine nasal spray. Overall, the results of this study indicate that
azelastine administered twice daily as an intranasal spray is a safe and efficacious treatment for the symptoms of
rhinitis in patients suffering from mild to moderate perennial
rhinitis.