Delivered by Ingenta to: University of Florida IP: 191.101.55.219 On: Sun, 26 Jun 2016 03:12:24 Copyright (c) Oceanside Publications, Inc. All rights reserved. For permission to copy go to https://www.oceansidepubl.com/permission.htm A comparison of fluticasone propionate nasal spray and cetirizine in ragweed fall seasonal allergic rhinitis Linda B. Ford, M.D., 1 Jonathan Matz, M.D., 2 Todd Hankinson, B.S., 3 Barbara Prillaman, M.Sc., 4 and George Georges, M.D. 5 ABSTRACT Background: Intranasal corticosteroids are generally considered the most effective medication class for controlling allergic rhinitis. Previous comparative studies with oral antihistamines have been only partially informative due to a variety of variables encountered during their execution. Objective: To compare fluticasone propionate nasal spray (FPNS) with the second-generation antihistamine cetirizine (oral tablet) and with placebo in a head-to-head study in a 2-week treatment study during fall ragweed season. Methods: A total of 978 subjects were screened for this study. Six hundred and eighty-two subjects were randomized into the study (170 subjects, FPNS 200 mcg once daily; 170, cetirizine 10 mg once daily; 171, FPNS placebo; 171, cetirizine placebo) and comprised the intent-to-treat population. A 1-week placebo run-in was followed by a 2-week active treatment period during which time a total nasal symptom score (TNSS), total ocular symptom score, and the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire were collected. Results: The primary efficacy end point was the mean change from baseline over the entire treatment period in A.M. reflective TNSS. The TNSS was the sum of the four individual nasal congestion, nasal itching, rhinorrhea, and sneezing scores, in which each symptom was scored on a scale of 0 to 3. Both FPNS and cetirizine improved the primary end point when compared with placebo during the active treatment period. Although there was a trend that favored FPNS with regard to the primary and secondary end points, there was not a statistical difference between the two treatments. Conclusion: FPNS and cetirizine were equally effective in treating fall seasonal allergic rhinitis during a 2-week head-to-head treatment investigation. Clinical trial NCT01916226, www.clinicaltrials.gov (Allergy Asthma Proc 36:313–319, 2015; doi: 10.2500/aap.2015.36.3860) A llergic rhinitis (AR) is a common chronic respira- tory illness that affects quality of life and pro- ductivity. Seasonal AR (SAR), also known as hay fever, affects 20% of people of all ages. 1 AR is an immuno- globulin E mediated disease that is thought to occur after exposure to airborne allergens, e.g., pollen. Symp- toms include rhinorrhea, nasal congestion, obstruction, and pruritus. 2 In 2001, Allergic Rhinitis and Its Impact on Asthma guidelines were published in cooperation with the World Health Organization, which indicate that the treatment of AR makes use of a combination of patient education, allergen avoidance, pharmacother- apy, and immunotherapy. 3 Pharmacologic options for the treatment of AR include intranasal corticosteroids, oral and topical antihistamines, decongestants, intranasal cromolyn (Nasalcrom; McNeil Comsumer Healthcare, Fort Washington, PA), intranasal anticholinergics, and leukotriene receptor antagonists. Second-generation oral antihistamines (OAHs) are now widely available over the counter (OTC) and have been recommended as first-line therapy for mild symp- toms of AR 4 because of their safety and ease of use. OAHs are predominantly effective on neurally medi- ated symptoms 2 of itching, sneezing, and rhinorrhea; however, these agents have a modest impact on nasal congestion. Intranasal corticosteroids are considered the most- effective medications for treating AR 5,6 and have been recommended as first-line therapy for moderate-to- severe symptoms. 2,4 They act by decreasing the influx of inflammatory cells and inhibiting the release of cy- tokines, thereby reducing inflammation of the nasal mucosa. 3 A meta-analysis of a large number of stud- From the 1 The Asthma and Allergy Center, Bellevue, Nebraska, 2 Chesapeake Clinical Research Inc., Baltimore, Maryland, 3 Respiratory Global Clinical Sciences and Oper- ations, GlaxoSmithKline (GSK), Research Triangle Park, North Carolina, 4 Clinical Statistics, GSK, Research Triangle Park, North Carolina, and 5 Respiratory Medicines Development Center, GlaxoSmithKline, Research Triangle Park, North Carolina The study was funded by GSK (study 200165) L.B. Ford has received support from GSK to conduct this study and her institution has received research grants from Teva, F. Hoffmann-La Roche, Novartis, AstraZeneca, Merck, Sanofi, Circassia, Forest, Johnson and Johnson, Amgen, Mylan, Aquinox, Perrigo, Oriel, Pfizer, Roxanne, and Biota. J. Matz has received support from GSK to conduct this study, has served as a consultant for Biota, has received payment for the development of educational programs from Novartis, and his institution has received research grants or has grants pending from Teva, Perrigo, Merck, Shionogi, and Greer. T. Hankinson, B. Prillaman, and G. Georges were employees of GSK and held stock in GSK at the time of study conduct and during the writing of this manuscript Supplemental data available at www.IngentaConnect.com Address correspondence to Linda Ford, M.D., The Asthma & Allergy Center, 3503 Samson Way, Suite 108, Bellevue, NE 68123 E-mail address: lford@asthmaandallergycenter.com Copyright © 2015, OceanSide Publications, Inc., U.S.A. Allergy and Asthma Proceedings 313 DO NOT COPY