Treatment of severe seasonal rhinoconjunctivitis by a combination of azelastine nasal spray and eye drops: A double blind, double-placebo study

Background: Evaluation of combined azelastine nasal spray and eye drops tre atment in patients with severe rhinoconjunctivitis. Methods: Phase LII, mul ticenter, randomized, double-blind study of patients with a history of gras s pollen allergy confirmed by skin testing/specific IgE, total symptom scor es greater than or equal to6 (ocular) or greater than or equal to8 (nasal). Intent-to-treat analysis. Results 99 patients (azelastine = 53, placebo = 46) enrolled homogeneously from May to September 1997 in 7 venues in France . The efficacy of azelastine was significantly higher compared to placebo ( 49% vs. 28%, p = 0.04), considering response as a decrease of the total sum of ocular and nasal scores by at least 50% and no use of cetirizine by day 7. The decrease of total ocular and nasal scores by at least 50% at day 7, with cetirizine rescue <3 tablets was higher, but not significantly, in az elastine patients (43% vs. 30%). Cetirizine rescue was more frequent, from day 0 to 7, in the placebo patients (4.9 +/- 5.0 vs. 2.7 +/- 4.1,p = 0.02). Global efficacy was rated higher for azelastine by investigators (26% vs. 10%,p = 0.05) and patients (28% vs. 7%, p = 0.01). Adverse events were burn ing sensation, "red eyes," nasal irritation, bitter taste. No serious adver se events were reported. Tolerance of azelastine was "very good/good"/"sati sfactory" in the majority (62 %/82% assessed by investigators, or 55%/79% b y patients, respectively). Conclusions: Combining azelastine eye drops and nasal spray is a safe and effective treatment of severe seasonal rhinoconju nctivitis.