Background: Recent data suggested that daytime somnolence in patients with
allergic rhinitis was secondary to disrupted sleep caused by nasal congesti
on. Medications, which decreased congestion, would be expected to improve s
leep and daytime somnolence. Previously, we demonstrated that nasal steroid
s improved all three symptoms. The effect of topical nasal antihistamines o
n these symptoms has yet to be studied.
Objective: The objective of this 8-week, double-blind, placebo-controlled s
tudy was to determine whether topical nasal azelastine was effective at dec
reasing congestion, daytime somnolence, and improving sleep.
Methods: We recruited 24 subjects with perennial allergic rhinitis and rand
omized them in a double-blinded, crossover fashion, to receive placebo or a
zelastine two sprays BID, using Balaam's design. Questionnaires, daily diar
y, and Epworth Sleepiness Scale were used as tools. The last 2 weeks of eac
h 4-week treatment period were summarized, scored and compared by PROC MIXE
D in SAS.
Results: The analysis of the Rhinitis Severity Score showed significant imp
rovement only of rhinorrhea in the azelastine group (P = .03). The symptom
severity of nasal congestion and daytime somnolence was not significantly d
ifferent between placebo and azelastine. Subjects considered azelastine eff
ective at improving their sleep (P = .04), but daytime somnolence (P = .06)
and congestion (P = .09) were not statistically improved.
Conclusion: Azelastine is effective in reducing rhinorrhea and improving sl
eep quality. We were unable to demonstrate that azelastine can significantl
y reduce the severity of congestion or daytime somnolence.