Effect of topical nasal azelastine on the symptoms of rhinitis, sleep, and daytime somnolence in perennial allergic rhinitis.
BACKGROUND
Recent data suggested that daytime somnolence in patients with allergic rhinitis was secondary to disrupted sleep caused by nasal congestion. Medications, which decreased congestion, would be expected to improve sleep and daytime somnolence. Previously, we demonstrated that nasal steroids improved all three symptoms. The effect of topical nasal antihistamines on these symptoms has yet to be studied.


OBJECTIVE
The objective of this 8-week, double-blind, placebo-controlled study was to determine whether topical nasal azelastine was effective at decreasing congestion, daytime somnolence, and improving sleep.


METHODS
We recruited 24 subjects with perennial allergic rhinitis and randomized them in a double-blinded, crossover fashion, to receive placebo or azelastine two sprays BID, using Balaam's design. Questionnaires, daily diary, and Epworth Sleepiness Scale were used as tools. The last 2 weeks of each 4-week treatment period were summarized, scored, and compared by PROC MIXED in SAS.


RESULTS
The analysis of the Rhinitis Severity Score showed significant improvement only of rhinorrhea in the azelastine group (P = .03). The symptom severity of nasal congestion and daytime somnolence was not significantly different between placebo and azelastine. Subjects considered azelastine effective at improving their sleep (P = .04), but daytime somnolence (P = .06) and congestion (P = .09) were not statistically improved.


CONCLUSIONS
Azelastine is effective in reducing rhinorrhea and improving sleep quality. We were unable to demonstrate that azelastine can significantly reduce the severity of congestion or daytime somnolence.
College of Medicine, Penn State University, Hershey Medical Center, Pennsylvania 17033, USA.
S
S
Golden
S J
SJ
Teets
E B
EB
Lehman
E A
EA
Mauger
V
V
Chinchilli
J M
JM
Berlin
S
S
Kakumanu
T
T
Lucus
T J
TJ
Craig
D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D002940:Circadian Rhythm / Q000187:drug effects; D018592:Cross-Over Studies; D004311:Double-Blind Method; D006634:Histamine H1 Antagonists / Q000008:administration & dosage / Q000494:pharmacology*; D006801:Humans; D008875:Middle Aged; D009297:Nasal Mucosa / Q000187:drug effects; D010793:Phthalazines / Q000008:administration & dosage*; D012220:Rhinitis / Q000517:prevention & control*; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy; D012890:Sleep / Q000187:drug effects*
D006634:Histamine H1 Antagonists; D010793:Phthalazines; C020976:azelastine