Double-blind, placebo-controlled trial of reformulated azelastine nasal spray in
patients with seasonal allergic rhinitis.
Author(s): Bernstein JA, Prenner B, Ferguson BJ, Portnoy J, Wheeler WJ, Sacks HJ.
Affiliation(s): Bernstein Clinical Research Center, Cincinnati, Ohio 45267-0563, USA.
Jonathan.Bernstein@uc.edu
Publication date & source: 2009, Am J Rhinol Allergy. , 23(5):512-7
BACKGROUND: Azelastine nasal spray is a topical antihistamine with a distinctive
taste that may be objectionable to some patients. The primary objectives of this
clinical trial were (1) to determine if a reformulated azelastine nasal spray
(Astepro) with sucralose as a taste-masking agent provides comparable efficacy to
the original formulation (Astelin) and (2) to evaluate dose-response
relationships between groups.
METHODS: Eight hundred thirty-five patients with seasonal allergic rhinitis were
randomized to six treatment groups: (1) original azelastine nasal spray, 1
spray/nostril b.i.d.; (2) reformulated azelastine, 1 spray/nostril b.i.d.; (3)
placebo, 1 spray/ nostril b.i.d.; (4) original azelastine nasal spray, 2
sprays/nostril b.i.d., (5) reformulated, 2 sprays/nostril b.i.d.; and (6)
placebo, 2 sprays/nostril b.i.d. The primary efficacy variable was the change
from baseline to day 14 in total nasal symptom score (TNSS) consisting of runny
nose, sneezing, itchy nose, and nasal congestion.
RESULTS: Original azelastine nasal spray and the reformulated spray produced
comparable improvements in the TNSS at both dosages. There was a dose-related
difference in TNSS comparing the 1- and 2-spray dosages. The percentage changes
from baseline in the TNSS in the 2-sprays/nostril dosage groups were 27.9%
(p<0.001) with the reformulated nasal spray, 23.5% (p<0.01) with the original
formulation, and 15.4% with placebo. The incidence of bitter taste was 7% with
the reformulated spray and 8% with the original at the 2-sprays/nostril dosage.
CONCLUSION: The results of this study showed efficacy both with original
azelastine nasal spray and with the reformulated nasal spray and a clear
dose-response difference between the 1- and 2-spray dosages.
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