Efficacy of azelastine nasal spray in patients with an unsatisfactory response to loratadine.
OBJECTIVE
To evaluate the effectiveness and safety of azelastine nasal spray, desloratadine, and the combination of azelastine nasal spray plus loratadine compared with placebo in patients with seasonal allergic rhinitis who had an unsatisfactory response to loratadine.


METHODS
This was a 2-week, multicenter, placebo-controlled, randomized, double-blind study in patients with moderate-to-severe symptoms of seasonal allergic rhinitis. Following a 1-week, open-label lead-in period, during which the patients received loratadine 10 mg daily, those patients who met the symptom qualification criteria (<25% to 33% improvement taking loratadine) were randomized to treatment with azelastine nasal spray 2 sprays per nostril, twice daily, azelastine nasal spray 2 sprays per nostril, twice daily, plus loratadine 10 mg daily, desloratadine 5 mg daily plus placebo (saline) nasal spray, or placebo (saline) nasal spray/placebo capsules. The primary efficacy variable was the change from baseline to day 14 in the total nasal symptom score, consisting of runny nose, sneezing, itchy nose, and nasal congestion symptom scores recorded twice daily (AM and PM) in patient diary cards.


RESULTS
A total of 428 patients with an unsatisfactory response to loratadine completed the double-blind treatment period. After 2 weeks of treatment, azelastine nasal spray (P < 0.001), azelastine nasal spray plus loratadine (P < 0.001), and desloratadine (P = 0.039) significantly improved the total nasal symptom score compared with placebo.


CONCLUSIONS
Azelastine nasal spray is an effective treatment for patients with seasonal allergic rhinitis who do not respond to loratadine and is an alternative to switching to another oral antihistamine or to using multiple antihistamines.
Berger
William E
WE
Southern California Research Center, Mission Viejo, California 92691, USA. weberger@uci.edu
White
Martha V
MV
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D018926:Anti-Allergic Agents / Q000008:administration & dosage*; D002648:Child; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D039563:Histamine H1 Antagonists, Non-Sedating / Q000627:therapeutic use*; D006801:Humans; D017336:Loratadine / Q000008:administration & dosage* / Q000031:analogs & derivatives / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010793:Phthalazines / Q000008:administration & dosage*; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy*; D012912:Sneezing / Q000187:drug effects
D018926:Anti-Allergic Agents; D039563:Histamine H1 Antagonists, Non-Sedating; D010793:Phthalazines; D017336:Loratadine; C121345:desloratadine; C020976:azelastine