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.
RCT Entities:
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.
Authors: Sarah K Wise; Sandra Y Lin; Elina Toskala; Richard R Orlandi; Cezmi A Akdis; Jeremiah A Alt; Antoine Azar; Fuad M Baroody; Claus Bachert; G Walter Canonica; Thomas Chacko; Cemal Cingi; Giorgio Ciprandi; Jacquelynne Corey; Linda S Cox; Peter Socrates Creticos; Adnan Custovic; Cecelia Damask; Adam DeConde; John M DelGaudio; Charles S Ebert; Jean Anderson Eloy; Carrie E Flanagan; Wytske J Fokkens; Christine Franzese; Jan Gosepath; Ashleigh Halderman; Robert G Hamilton; Hans Jürgen Hoffman; Jens M Hohlfeld; Steven M Houser; Peter H Hwang; Cristoforo Incorvaia; Deborah Jarvis; Ayesha N Khalid; Maritta Kilpeläinen; Todd T Kingdom; Helene Krouse; Desiree Larenas-Linnemann; Adrienne M Laury; Stella E Lee; Joshua M Levy; Amber U Luong; Bradley F Marple; Edward D McCoul; K Christopher McMains; Erik Melén; James W Mims; Gianna Moscato; Joaquim Mullol; Harold S Nelson; Monica Patadia; Ruby Pawankar; Oliver Pfaar; Michael P Platt; William Reisacher; Carmen Rondón; Luke Rudmik; Matthew Ryan; Joaquin Sastre; Rodney J Schlosser; Russell A Settipane; Hemant P Sharma; Aziz Sheikh; Timothy L Smith; Pongsakorn Tantilipikorn; Jody R Tversky; Maria C Veling; De Yun Wang; Marit Westman; Magnus Wickman; Mark Zacharek Journal: Int Forum Allergy Rhinol Date: 2018-02 Impact factor: 3.858