Impact of azelastine nasal spray on symptoms and quality of life compared with cetirizine oral tablets in patients with seasonal allergic rhinitis.
BACKGROUND
In fall 2004, the first Azelastine Cetirizine Trial demonstrated statistically significant improvements in the total nasal symptom score (TNSS) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores with the use of azelastine nasal spray vs oral cetirizine in patients with seasonal allergic rhinitis (SAR).


OBJECTIVE
To compare the effects of azelastine nasal spray vs cetirizine on the TNSS and RQLQ scores in patients with SAR.


METHODS
This 2-week, double-blind, multicenter trial randomized 360 patients with moderate-to-severe SAR to azelastine, 2 sprays per nostril twice daily, or cetirizine, 10-mg tablets once daily. The primary efficacy variable was the 12-hour reflective TNSS (rhinorrhea, sneezing, itchy nose, and nasal congestion). Secondary efficacy variables were individual symptom scores and the RQLQ score.


RESULTS
Azelastine nasal spray and cetirizine significantly improved the TNSS and individual symptoms compared with baseline (P < .001). The TNSS improved by a mean of 4.6 (23.9%) with azelastine nasal spray compared with 3.9 (19.6%) with cetirizine. Significant differences favoring azelastine nasal spray were seen for the individual symptoms of sneezing and nasal congestion. Improvements in the RQLQ overall (P = .002) and individual domain (P < or = .02) scores were greater with azelastine nasal spray. Both treatments were well tolerated.


CONCLUSIONS
Azelastine nasal spray and cetirizine effectively treated nasal symptoms in patients with SAR. Improvements in the TNSS and individual symptoms favored azelastine over cetirizine, with significant differences for nasal congestion and sneezing. Azelastine nasal spray significantly improved the RQLQ overall and domain scores compared with cetirizine.
Berger
William
W
Southern California Research, Mission Viejo 92691, USA. weberger@uci.edu
Hampel
Frank
F
Bernstein
Jonathan
J
Shah
Shailen
S
Sacks
Harry
H
Meltzer
Eli O
EO
D000281:Administration, Intranasal; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D018926:Anti-Allergic Agents / Q000008:administration & dosage*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage; D017332:Cetirizine / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D039563:Histamine H1 Antagonists, Non-Sedating / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008875:Middle Aged; D010793:Phthalazines / Q000008:administration & dosage*; D011788:Quality of Life; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy*; D011795:Surveys and Questionnaires; D013607:Tablets
D018926:Anti-Allergic Agents; D000894:Anti-Inflammatory Agents, Non-Steroidal; D039563:Histamine H1 Antagonists, Non-Sedating; D010793:Phthalazines; D013607:Tablets; D017332:Cetirizine; C020976:azelastine