BACKGROUND: A previous study with azelastine nasal spray in patients with seasonal allergic rhinitis (SAR) demonstrated that increasing the azelastine concentration from 0.1% to 0.15% allowed for once-daily dosing without increasing the incidence of adverse effects. This study evaluated the efficacy of azelastine 0.15% nasal spray administered once daily for treating symptoms of SAR. METHODS: In this 14-day, randomized, double-blind, placebo-controlled study, patients with moderate-to-severe SAR were randomized to azelastine 0.15% (n = 251) or placebo (n = 255), both at a dosage of 2 sprays/nostril once daily. The primary efficacy variable was change from baseline in the 12-hour reflective Total Nasal Symptom Score (TNSS). Key secondary variables were change from baseline in 24-hour instantaneous TNSS, to establish the dosing interval, and change from baseline in the Total Ocular Symptom Score (TOSS). RESULTS: The mean improvement (3.57) and percentage improvement (19.3%) in 12-hour reflective TNSS was significant (p < 0.012) with azelastine 0.15% compared to placebo (2.14 and 11.4%, respectively). The mean improvement in 24-hour instantaneous TNSS was also significant (p < 0.001) for azelastine 0.15% compared to placebo, indicating efficacy with once-daily dosing. The overall improvement and percentage improvement in TOSS was significant (p ≤ 0.012) with azelastine 0.15% (2.21 and 16.7%, respectively) compared to placebo (1.28 and 6.0%, respectively). The overall score for the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) was significantly (p < 0.001) improved from baseline in the azelastine group compared with the placebo group. Nasal discomfort (3.6%) and bitter taste (2.4%) were the most common adverse events. There were no reports of somnolence with azelastine. CONCLUSION:Azelastine 0.15% was effective and well tolerated with once-daily dosing. Azelastine 0.15% nasal spray significantly improved a complex of eye symptoms compared to placebo.
RCT Entities:
BACKGROUND: A previous study with azelastine nasal spray in patients with seasonal allergic rhinitis (SAR) demonstrated that increasing the azelastine concentration from 0.1% to 0.15% allowed for once-daily dosing without increasing the incidence of adverse effects. This study evaluated the efficacy of azelastine 0.15% nasal spray administered once daily for treating symptoms of SAR. METHODS: In this 14-day, randomized, double-blind, placebo-controlled study, patients with moderate-to-severe SAR were randomized to azelastine 0.15% (n = 251) or placebo (n = 255), both at a dosage of 2 sprays/nostril once daily. The primary efficacy variable was change from baseline in the 12-hour reflective Total Nasal Symptom Score (TNSS). Key secondary variables were change from baseline in 24-hour instantaneous TNSS, to establish the dosing interval, and change from baseline in the Total Ocular Symptom Score (TOSS). RESULTS: The mean improvement (3.57) and percentage improvement (19.3%) in 12-hour reflective TNSS was significant (p < 0.012) with azelastine 0.15% compared to placebo (2.14 and 11.4%, respectively). The mean improvement in 24-hour instantaneous TNSS was also significant (p < 0.001) for azelastine 0.15% compared to placebo, indicating efficacy with once-daily dosing. The overall improvement and percentage improvement in TOSS was significant (p ≤ 0.012) with azelastine 0.15% (2.21 and 16.7%, respectively) compared to placebo (1.28 and 6.0%, respectively). The overall score for the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) was significantly (p < 0.001) improved from baseline in the azelastine group compared with the placebo group. Nasal discomfort (3.6%) and bitter taste (2.4%) were the most common adverse events. There were no reports of somnolence with azelastine. CONCLUSION:Azelastine 0.15% was effective and well tolerated with once-daily dosing. Azelastine 0.15% nasal spray significantly improved a complex of eye symptoms compared to placebo.
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
Authors: Li Eon Kuek; Derek B McMahon; Ray Z Ma; Zoey A Miller; Jennifer F Jolivert; Nithin D Adappa; James N Palmer; Robert J Lee Journal: Pharmaceuticals (Basel) Date: 2022-04-06