The improved efficacy of a fixed‐dose combination of fluticasone furoate and levocabastine relative to the individual components in the treatment of allergic rhinitis. Issue 8 (August 2015)

• Record Type: Journal Article
• Authors: Murdoch, R. D.; Bareille, P.; Ignar, D.; Miller, S. R.; Gupta, A.; Boardley, R.; Zieglmayer, P.; Zieglmayer, R.; Lemel, P.; Horak, F.
• Is Part Of: Clinical & experimental allergy. Volume 45:Issue 8(2015:Aug.)
• Page Start: 1346
• Page End: 1355
• Publication Date: 2015-08
• Subjects: Allergy -- Periodicals; Immunology -- Periodicals; 616.97
• DOI: 10.1111/cea.12556
• Languages: English
• ISSNs: 0954-7894

Abstract

<abstract abstract-type="main" id="cea12556-abs-0001"> <title>Summary</title> <sec id="cea12556-sec-0001" sec-type="section"> <title>Background</title> <p>Allergic rhinitis (AR) is a common chronic disease, which has significant detrimental effect on well‐being and quality of life as well as substantial socio‐economic impact. Combination pharmacotherapy is utilized by 40–50% of patients to treat their symptoms.</p> </sec> <sec id="cea12556-sec-0002" sec-type="section"> <title>Objective</title> <p>To compare the effects of intranasal fluticasone furoate (FF)/levocabastine (LEVO) fixed‐dose combination (FDC) with each component alone on allergen‐induced nasal and ocular symptoms.</p> </sec> <sec id="cea12556-sec-0003" sec-type="section"> <title>Methods</title> <p>A randomized, double‐blind, placebo‐controlled, three‐way, incomplete block, cross‐over, proof‐of‐concept study in 71 patients with AR, evaluated FF 100 μg, LEVO 200 μg and FDC (FF 100/LEVO 200 μg), once daily via intranasal spray for 8 days. On days 1 and 8, total nasal symptom score (TNSS) and total ocular symptom score (TOSS) were assessed every 15 min during a 4‐h allergen exposure in the Vienna Challenge Chamber. The primary endpoint was Day 8 weighted mean TNSS.</p> </sec> <sec id="cea12556-sec-0004" sec-type="section"> <title>Results</title> <p>After 8 days, FDC resulted in both statistically and clinically significant reductions in mean TNSS compared with FF and LEVO alone [adjusted mean differences (95% CI): FDC vs. FF: −2.26 (−2.90, −1.62); FDC vs. LEVO: −2.57 (−3.21, −1.93)]. All active treatments were significantly superior to placebo [adjusted mean difference (95% CI) from placebo: FDC: −4.1 (−4.86, −3.34); FF: −1.84 (−2.66, −1.03); LEVO: −1.53 (−2.34, −0.72)]. Onset of action was rapid following FDC and LEVO treatment with an approximate two unit reduction in mean TNSS from pre‐dose levels by 30 min and 1 h. Mean TOSS was also reduced following all active treatments relative to placebo (range 0.6–0.8 unit reduction). All treatments were equally well tolerated.</p> </sec> <sec id="cea12556-sec-0005" sec-type="section"> <title>Conclusions and Clinical Relevance</title> <p>These results suggest that once daily FF/LEVO FDC could provide a clinical therapeutic advantage to existing standard monotherapies in the treatment of moderate‐to‐severe AR, and support progression to evaluation in larger phase III clinical studies.</p> </sec> </abstract>