Paul Ratner1, Julius Van Bavel2, Dale Mohar3, Robert L Jacobs4, Frank Hampel5, William Howland6, Ritu Karwal7. 1. Sylvana Research Associates, San Antonio, Texas. Electronic address: pratner@sylvanaresearch.com. 2. Isis Clinical Research, Austin, Texas. 3. Kerville Research Associates, Kerrville, Texas. 4. Biogenics Research Institute, San Antonio, Texas. 5. Central Texas Health Research, New Braunfels, Texas. 6. Sirius Clinical Research, Austin, Texas. 7. GlaxoSmithKline Consumer Healthcare, Parsippany, New Jersey.
Abstract
BACKGROUND:Allergic rhinitis (AR) is an inflammatory condition of the nasal mucosa characterized by symptoms of nasal discharge, itching, sneezing, and congestion. Ocular symptoms are commonly associated with AR and include itching or burning, tearing or watering, and redness. Intranasal corticosteroids are a mainstay of treatment, and their effect on nasal symptoms is well described. OBJECTIVE: To demonstrate that a 14-day course of 200 μg/d of nasal fluticasone propionate is superior to placebo in relieving ocular symptoms associated with AR. METHODS: This was a randomized, double-blind, parallel group, multicenter study comparing 200 μg/d of fluticasone propionate with placebo in patients with seasonal allergic rhinitis. The primary end point was mean change from baseline in patient-rated reflective total ocular symptom score (rTOSS). Key secondary end points included mean change from baseline in the morning and evening rTOSS, end-of-treatment assessment of response, and effect on activities of daily living. The primary analysis was performed using analysis of covariance with a linear fixed-effects model. RESULTS:Fluticasone was statistically significantly more efficacious in reducing the ocular symptoms of AR than placebo. The least squares mean difference in the change from baseline of rTOSS was -0.36 (P = .002). A statistically significant difference in mean change from baseline was observed in favor of fluticasone for morning and evening rTOSS. Significantly more patients taking fluticasone achieved an overall response compared with placebo. Fluticasone had a significantly greater effect on daily living activities and was well tolerated. CONCLUSION: This study supports the efficacy of fluticasone in treating ocular symptoms associated with AR. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01817790.
RCT Entities:
BACKGROUND:Allergic rhinitis (AR) is an inflammatory condition of the nasal mucosa characterized by symptoms of nasal discharge, itching, sneezing, and congestion. Ocular symptoms are commonly associated with AR and include itching or burning, tearing or watering, and redness. Intranasal corticosteroids are a mainstay of treatment, and their effect on nasal symptoms is well described. OBJECTIVE: To demonstrate that a 14-day course of 200 μg/d of nasal fluticasone propionate is superior to placebo in relieving ocular symptoms associated with AR. METHODS: This was a randomized, double-blind, parallel group, multicenter study comparing 200 μg/d of fluticasone propionate with placebo in patients with seasonal allergic rhinitis. The primary end point was mean change from baseline in patient-rated reflective total ocular symptom score (rTOSS). Key secondary end points included mean change from baseline in the morning and evening rTOSS, end-of-treatment assessment of response, and effect on activities of daily living. The primary analysis was performed using analysis of covariance with a linear fixed-effects model. RESULTS:Fluticasone was statistically significantly more efficacious in reducing the ocular symptoms of AR than placebo. The least squares mean difference in the change from baseline of rTOSS was -0.36 (P = .002). A statistically significant difference in mean change from baseline was observed in favor of fluticasone for morning and evening rTOSS. Significantly more patients taking fluticasone achieved an overall response compared with placebo. Fluticasone had a significantly greater effect on daily living activities and was well tolerated. CONCLUSION: This study supports the efficacy of fluticasone in treating ocular symptoms associated with AR. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01817790.
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: Michele Miraglia Del Giudice; Annalisa Allegorico; Gian Luigi Marseglia; Alberto Martelli; Mauro Calvani; Fabio Cardinale; Marzia Duse; Elena Chiappini; Sara Manti; Claudio Cravidi; Maria Angela Tosca; Carlo Caffarelli Journal: Acta Biomed Date: 2020-09-15