A double-blind, controlled trial to assess the safety and efficacy of azelastine nasal spray in seasonal allergic rhinitis.
BACKGROUND
Azelastine solution is a topically (nasal) administered antiallergy drug with a preclinical profile suggestive of efficacy in patients with allergic rhinitis.


OBJECTIVE
The study was designed to compare the effectiveness and safety of two dosages of azelastine nasal spray (2 sprays per nostril once daily and twice daily) with that of placebo in the treatment of patients with symptomatic seasonal allergic rhinitis.


METHODS
Two hundred fifty-one patients (12 years of age or older) were randomized to treatment in this 2-week, double-blind, parallel-group study. Primary efficacy variables were Major Symptom Complex (nose blows, sneezes, runny nose, itchy nose, watery eyes) and Total Symptoms Complex (Major Symptom Complex plus itchy eyes/ears/throat/palate, cough, postnasal drip).


RESULTS
Patients treated with azelastine had mean percent improvements in Total and Major Symptom Complex scores that were consistently superior to placebo at each evaluation point. Overall, improvements were statistically significant (p < or = 0.05) in the Total Symptoms Complex for both azelastine groups and in the Major Symptom Complex for the twice daily group with a trend toward statistical significance for the once daily group. Azelastine was superior to placebo in improving all individual rhinitis symptoms. Adverse experiences in the azelastine groups were minor and infrequent.


CONCLUSIONS
The results support the efficacy and safety of azelastine nasal spray in the treatment of seasonal allergic rhinitis.
Ratner
P H
PH
Sylvana Research, San Antonio, TX 78229.
Findlay
S R
SR
Hampel
F
F
van Bavel
J
J
Widlitz
M D
MD
Freitag
J J
JJ
D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000368:Aged; D001993:Bronchodilator Agents / Q000627:therapeutic use; D002648:Child; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010793:Phthalazines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy*; D016896:Treatment Outcome
D001993:Bronchodilator Agents; D010793:Phthalazines; C020976:azelastine