BACKGROUND: In fall 2004, the first Azelastine Cetirizine Trial demonstrated statistically significant improvements in the total nasal symptom score (TNSS) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores with the use of azelastine nasal spray vs oral cetirizine in patients with seasonal allergic rhinitis (SAR). OBJECTIVE: To compare the effects of azelastine nasal spray vs cetirizine on the TNSS and RQLQ scores in patients with SAR. METHODS: This 2-week, double-blind, multicenter trial randomized 360 patients with moderate-to-severe SAR toazelastine, 2 sprays per nostril twice daily, or cetirizine, 10-mg tablets once daily. The primary efficacy variable was the 12-hour reflective TNSS (rhinorrhea, sneezing, itchy nose, and nasal congestion). Secondary efficacy variables were individual symptom scores and the RQLQ score. RESULTS:Azelastine nasal spray and cetirizine significantly improved the TNSS and individual symptoms compared with baseline (P < .001). The TNSS improved by a mean of 4.6 (23.9%) with azelastine nasal spray compared with 3.9 (19.6%) with cetirizine. Significant differences favoring azelastine nasal spray were seen for the individual symptoms of sneezing and nasal congestion. Improvements in the RQLQ overall (P = .002) and individual domain (P < or = .02) scores were greater with azelastine nasal spray. Both treatments were well tolerated. CONCLUSIONS:Azelastine nasal spray and cetirizine effectively treated nasal symptoms in patients with SAR. Improvements in the TNSS and individual symptoms favored azelastine over cetirizine, with significant differences for nasal congestion and sneezing. Azelastine nasal spray significantly improved the RQLQ overall and domain scores compared with cetirizine.
RCT Entities:
BACKGROUND: In fall 2004, the first AzelastineCetirizine Trial demonstrated statistically significant improvements in the total nasal symptom score (TNSS) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores with the use of azelastine nasal spray vs oral cetirizine in patients with seasonal allergic rhinitis (SAR). OBJECTIVE: To compare the effects of azelastine nasal spray vs cetirizine on the TNSS and RQLQ scores in patients with SAR. METHODS: This 2-week, double-blind, multicenter trial randomized 360 patients with moderate-to-severe SAR to azelastine, 2 sprays per nostril twice daily, or cetirizine, 10-mg tablets once daily. The primary efficacy variable was the 12-hour reflective TNSS (rhinorrhea, sneezing, itchy nose, and nasal congestion). Secondary efficacy variables were individual symptom scores and the RQLQ score. RESULTS:Azelastine nasal spray and cetirizine significantly improved the TNSS and individual symptoms compared with baseline (P < .001). The TNSS improved by a mean of 4.6 (23.9%) with azelastine nasal spray compared with 3.9 (19.6%) with cetirizine. Significant differences favoring azelastine nasal spray were seen for the individual symptoms of sneezing and nasal congestion. Improvements in the RQLQ overall (P = .002) and individual domain (P < or = .02) scores were greater with azelastine nasal spray. Both treatments were well tolerated. CONCLUSIONS:Azelastine nasal spray and cetirizine effectively treated nasal symptoms in patients with SAR. Improvements in the TNSS and individual symptoms favored azelastine over cetirizine, with significant differences for nasal congestion and sneezing. Azelastine nasal spray significantly improved the RQLQ overall and domain scores compared with cetirizine.
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