Abstract
Objective:This study investigated the clinical efficacy of a combination therapy of levocetirizine (LCTZ) and fluticasone furoate nasal spray (FFNS), compared with LCTZ monotherapy, for the suppression of seasonal allergic rhinitis (SAR) symptoms induced in an artificial exposure chamber.Methods:This study was a single-center, placebo-controlled, randomized, 3-way cross-over comparative study performed in 42 Japanese cedar pollinosis patients. These subjects received (1) LCTZ plus FFNS (combination group), (2) LCTZ plus FFNS placebo (monotherapy group), or (3) LCTZ placebo plus FFNS placebo (placebo group) once on the night prior to exposure, with a 1-week washout period between exposures. Nasal (sneezing, rhinorrhea, nasal congestion, and itchy nose) and ocular (eye itching and tearing) symptoms were recorded every 15 min, and the number of sneezes, nose blowing events, and the amount of nasal secretions were measured during exposure. The primary end-point was the cumulative incidence of SAR symptoms during exposure and the ‘ime to occurrence of symptoms’. The secondary end-points were the total nasal symptom score, the ocular symptom score, the amount of nasal discharge, and the number of sneezes and nose blowing events.Results:At all the measurement points, the lowest cumulative incidences for the nasal symptoms were observed in the combination group, followed by the monotherapy and placebo groups. All the subjects in the placebo group developed nasal symptoms within 2 h after pollen exposure, while three and eight subjects in the monotherapy and combination groups, respectively, did not develop any nasal symptoms during exposure. In addition, combination therapy delayed the onset of symptoms.Conclusions:The results demonstrated that combination therapy with FFNS and LCTZ significantly suppressed the induced SAR symptoms and delayed the onset of symptoms compared with LCTZ monotherapy and placebo. Although the conditions of the allergen challenge study using an exposure chamber are different from those in real life, combination therapy with FF and LCTZ was confirmed to be an effective treatment for SAR.
Highlights
The prevalence of allergic rhinitis (AR) has increased both globally[1] and in Japan[2]
Combination therapy with fluticasone furoate and levocetirizine Hashiguchi et al 95 published evaluating the efficacy of this drug for the treatment of seasonal allergic rhinitis (SAR) under natural conditions, and the results showed a significantly greater efficacy for LCTZ, compared with placebo, in reducing the nasal symptom scores and the overall RQLQ scores[18]
The results showed that fluticasone furoate nasal spray (FFNS) was effective for improving the nasal symptoms of patients with Japanese cedar (JC) pollinosis and was non-inferior to fluticasone propionate nasal spray (FPNS)
Summary
The prevalence of allergic rhinitis (AR) has increased both globally[1] and in Japan[2]. The prevalence of seasonal allergic rhinitis (SAR) caused by Japanese cedar (JC) has increased over the past 10 years and is estimated to affect up to 26% of the Japanese population, according to nationwide surveillance data[2]. SAR symptoms, including rhinorrhea, sneezing attacks, nasal congestion, eye itching, and eye tearing, disturb daily life, and socioeconomics[3]. These symptoms are known to have a negative impact on daily work, school performance, and quality-of-life[3,4]. Pollinosis patients are eager to receive appropriate medication against SAR symptoms
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