Impact of azelastine nasal spray on symptoms and quality of life compared with
cetirizine oral tablets in patients with seasonal allergic rhinitis.
Author(s): Berger W, Hampel F Jr, Bernstein J, Shah S, Sacks H, Meltzer EO.
Affiliation(s): Southern California Research, Mission Viejo 92691, USA. weberger@uci.edu
Publication date & source: 2006, Ann Allergy Asthma Immunol. , 97(3):375-81
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.
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