Effect of topical nasal azelastine on the symptoms of rhinitis, sleep, and
daytime somnolence in perennial allergic rhinitis.
Author(s): Golden S, Teets SJ, Lehman EB, Mauger EA, Chinchilli V, Berlin JM, Kakumanu S,
Lucus T, Craig TJ.
Affiliation(s): College of Medicine, Penn State University, Hershey Medical Center, Pennsylvania
17033, USA.
Publication date & source: 2000, Ann Allergy Asthma Immunol. , 85(1):53-7
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.
CONCLUSION: 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.
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