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 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.
Duarte
C
C
Allergology Center, Tenon Hospital, University of Paris VI, France.
Baëhre
M
M
Gharakhanian
S
S
Leynadier
F
F
D000281:Administration, Intranasal; D000328:Adult; D018926:Anti-Allergic Agents / Q000008:administration & dosage* / Q000627:therapeutic use*; D003233:Conjunctivitis, Allergic / Q000628:therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000627:therapeutic use*; D010793:Phthalazines / Q000008:administration & dosage* / Q000627:therapeutic use*; D006255:Rhinitis, Allergic, Seasonal / Q000628:therapy*; D012720:Severity of Illness Index; D016896:Treatment Outcome
D018926:Anti-Allergic Agents; D009883:Ophthalmic Solutions; D010793:Phthalazines; C020976:azelastine