Abstract

Prophylactic treatment with intranasal corticosteroids is effective for pollen-induced seasonal allergic rhinitis. However, the appropriate time to start this treatment remains unclear. We performed a double-blinded, randomized, placebo-controlled trial. Starting on 1 February 2014, patients with Japanese cedar pollinosis received either fluticasone furoate nasal spray (FFNS) for 8 weeks (Group A: n = 24), placebo nasal spray for 2 weeks followed by FFNS for 6 weeks (Group B: n = 23), or placebo for 4 weeks followed by FFNS for 4 weeks (Group C: n = 23). The primary endpoint was comparison of the total naso-ocular symptom score (TSS). Secondary endpoints including the increment cost effective ratio (ICER) were also determined. Continuous pollen dispersion began on the 24th of February. Therefore, Group A and Group B received 3-weeks and 1-week of prophylactic treatment, respectively, whereas Group C received post-onset treatment. During the peak pollen-dispersal period, significant differences in TSS were seen between the groups, particularly between Group A and C. The ICER of Group B vs. Group C was lower than that of Group A vs. Group C. These results suggest that long-term prophylactic treatment with FFNS is clinically the most potent treatment, whereas short-term prophylactic treatment is cost effective for pollen-induced allergic rhinitis.

Highlights

  • Prophylactic treatment, an early interventional or initial treatment, is recommended for patients with pollinosis who annually experience substantial naso-ocular allergic symptoms during the pollen season [1]

  • Patients were excluded from the study if they had: (a) concomitant sinonasal disease that could potentially affect the outcome of the trial; (b) concomitant treatment for AR caused by allergens other than Japanese cedar pollen; (c) rhinitis medicamentosa and non-infectious, non-allergic rhinitis; (d) cedar pollen-specific immunotherapy; (e) sinonasal surgery including laser vaporization of inferior turbinates within the past year; (f) medication with anti-allergic drugs including H1RA, chromones, glucocorticoids and decongestants within 2 weeks of the study initiation; (g) hypersensitivity to fluticasone furoate nasal spray (FFNS); (h) systemic infection including mycosis; or (i) were pregnant and/or breastfeeding

  • Starting on 1 February 2014, patients received either FFNS (55 μg per nostril once a day in the morning) for 8 weeks (Group A: n = 24), a placebo nasal spray for 2 weeks followed by FFNS for 6 weeks (Group B: n = 23), or placebo for 4 weeks followed by FFNS for 4 weeks (Group C: n = 23)

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Summary

Introduction

Prophylactic treatment, an early interventional or initial treatment, is recommended for patients with pollinosis who annually experience substantial naso-ocular allergic symptoms during the pollen season [1]. (INS) [2,3] Of these medications, INS are selected in order to suppress pre-onset minimal persistent inflammation induced by a low exposure to pollens before continuous dispersal [4,5]. INS are selected in order to suppress pre-onset minimal persistent inflammation induced by a low exposure to pollens before continuous dispersal [4,5] It is well-known that this treatment delays the onset and reduces the symptom severity of pollinosis [3,6,7,8,9,10,11]

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