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

Author(s): Duarte C, Baehre M, Gharakhanian S, Leynadier F, French Azelastine Study Group

Affiliation(s): Allergology Center, Tenon Hospital, University of Paris VI, France.

Publication date & source: 2001, J Investig Allergol Clin Immunol., 11(1):34-40.

Publication type: Clinical Trial; Clinical Trial, Phase III; Multicenter Study; Randomized Controlled Trial

BACKGROUND: Evaluation of combined azelastine nasal spray and eye drops treatment in patients with severe rhinoconjunctivitis. METHODS: Phase III, multicenter, randomized, double-blind study of patients with a history of grass pollen allergy, confirmed by skin testing/specific IgE, total symptom scores > or =6 (ocular) or > or =8 (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 azelastine 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 burning sensation, "red eyes," nasal irritation, bitter taste. No serious adverse events were reported. Tolerance of azelastine was "very good/good"/"satisfactory" in the majority (62%/82% assessed by investigators, or 55%/79% by patients, respectively). CONCLUSIONS: Combining azelastine eye drops and nasal spray is a safe and effective treatment of severe seasonal rhinoconjunctivitis.