Efficacy of fluticasone furoate nasal spray vs. placebo for the treatment of ocular and nasal symptoms of allergic rhinitis: a systematic review

Rodrigo, Gustavo J.; Neffen, Hugo

doi:10.1111/j.1365-2222.2010.03654.x

Cited by 60 publications

(41 citation statements)

References 37 publications

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“…The safety and efficacy of FF nasal sprays to treat AR have been demonstrated in several clinical studies [30,31,32,33,34,35]. It has been demonstrated, for example, that FF inhibits GM-CSF and IL-8 production in primary bronchial airway epithelial cells, the human lung adenocarcinoma epithelial cell line (A 549) and SV40-immortalised airway bronchial epithelial cell line (BEAS-2B) [36,37].…”

Section: Introductionmentioning

confidence: 99%

Fluticasone Furoate Inhibits Cytokine Secretion from Nasal Epithelial Cells and Reduces Eosinophil Survival in an in vitro Model of Eosinophilic Inflammation

Mullol

Pujols

Alobid

et al. 2014

Int Arch Allergy Immunol

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Background: Fluticasone furoate (FF) is an intranasal corticosteroid indicated for the treatment of allergic rhinitis (AR). However, the anti-inflammatory effects of FF in the nasal mucosa have yet to be investigated thoroughly. The aim of this study was to investigate the effect of FF on eosinophil survival and cytokine secretion from nasal mucosa epithelial cells. Methods: Epithelial cells obtained from nasal mucosa were stimulated with 10% fetal bovine serum (FBS) in the presence of FF (from 10^-12 to 10^-7M) for 6-24 h. Cytokine [granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin (IL)-6 and IL-8] concentrations in supernatants were measured by ELISA. Peripheral blood eosinophils were incubated for 4 days with epithelial cell secretions in the presence or absence of FF (from 10^-12 to 10^-7M) and survival was assessed by Trypan blue dye exclusion. Results are expressed as medians of the minimum effective concentration and IC values. Results: FBS stimulated the secretion of GM-CSF, IL-6 and IL-8. FF significantly inhibited GM-CSF (up to 10^-10M, IC₂₅ = 12.6 pM), IL-6 (up to 10^-10M, IC₂₅ = 65.8 pM) and IL-8 (up to 10^-11M, IC₂₅ = 8.6 pM) secretion induced by FBS (n = 8). Epithelial cell secretions induced eosinophil survival from day 1 to day 4 (n = 6). This effect was significantly inhibited by FF (up to 10^-12M) at day 3 (IC₅₀ = 3.22 nM) and day 4 (IC₅₀ = 1.29 nM). Conclusions: The results obtained in this in vitro model suggest that FF may reduce upper airway eosinophilic inflammation through decreasing cytokine secretion from epithelial cells and reducing eosinophil survival.

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Section: Introductionmentioning

confidence: 99%

Fluticasone Furoate Inhibits Cytokine Secretion from Nasal Epithelial Cells and Reduces Eosinophil Survival in an in vitro Model of Eosinophilic Inflammation

Mullol

Pujols

Alobid

et al. 2014

Int Arch Allergy Immunol

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“…Of note, significantly lower nasal scores were observed in the combination group at home on the day of and on the day after exposure, compared with the monotherapy and placebo groups. The combination therapy, however, did not result in a more efficacious suppression of ocular symptoms, compared with the monotherapy, the long-term use of FFNS might be necessary to obtain clinical efficacy for the suppression of ocular symptoms, as indicated in the previous clinical studies21,34.…”

Section: Discussionmentioning

confidence: 91%

“…In addition, few systemic adverse effects have been reported, regardless of the duration of use, because of the low systemic bioavailability20. FFNS has been shown to be significantly effective for relieving nasal symptoms, compared with placebo, in adult patients with SAR in double-blind, placebo-controlled studies21. Prior to its approval in Japan in 2010, a Phase III, randomized, double-blind, placebo-controlled clinical study was conducted to compare the efficacy of the once-daily use of FFNS (110 μg) vs the twice-daily use of fluticasone propionate nasal spray (FPNS) (200 μg) for the treatment of adult patients with JC pollinosis22.…”

Section: Introductionmentioning

confidence: 99%

Efficacy of fluticasone furoate nasal spray and levocetirizine in patients with Japanese cedar pollinosis subjected to an artificial exposure chamber

Hashiguchi

Kanzaki

Wakabayashi

et al. 2013

Journal of Drug Assessment

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ObjectiveThis 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.MethodsThis 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.ResultsAt 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.ConclusionsThe 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.

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“…These effects were consistent across different allergy seasons and geographic locations, and were considered to be robust owing to the consistent use of ocular symptom scores to determine ocular efficacy [45]. The consistent efficacy of FFNS in relieving the ocular symptoms in patients with AR was further confirmed by a systematic review of 16 trials and an integrated analysis of 4 randomized placebo-controlled trials in patients with SAR [35,46]. …”

Section: Introductionmentioning

confidence: 89%

“…Evidence obtained more recently increasingly suggests that INSs may be effective in alleviating ocular symptoms (e.g. eye watering) [18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35]. …”

Section: Introductionmentioning

confidence: 99%

Should Intranasal Corticosteroids Be Used for the Treatment of Ocular Symptoms of Allergic Rhinoconjunctivitis? A Review of Their Efficacy and Safety Profile

Lightman

Scadding²

2012

Int Arch Allergy Immunol

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Allergic rhinoconjunctivitis (ARC) presents as nasal symptoms, eye watering and additional signs of ocular allergy (e.g. itchy/burning eyes). Intranasal corticosteroids (INSs) are the most effective treatment for the nasal symptoms of seasonal allergic rhinitis (SAR; based on 4 meta-analyses) and are considered first-line therapy when nasal congestion forms a substantial component of the patient’s rhinitis symptoms. Clinical trial evidence shows that INSs also provide some relief from ocular symptoms of SAR and seasonal ARC in adults. INSs probably alleviate eye watering, the main ocular symptom of SAR, by relieving nasal congestion. Other ocular symptoms also improve with INSs. The mechanism for this effect is unknown, but might relate to naso-ocular reflex reduction. There are limited data on ocular safety with INSs. However, the literature supports the use of INSs over several months as there appears to be no considerable increase in the risk of ocular hypertension or glaucoma.

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Efficacy of fluticasone furoate nasal spray vs. placebo for the treatment of ocular and nasal symptoms of allergic rhinitis: a systematic review

Cited by 60 publications

References 37 publications

Fluticasone Furoate Inhibits Cytokine Secretion from Nasal Epithelial Cells and Reduces Eosinophil Survival in an in vitro Model of Eosinophilic Inflammation

Fluticasone Furoate Inhibits Cytokine Secretion from Nasal Epithelial Cells and Reduces Eosinophil Survival in an in vitro Model of Eosinophilic Inflammation

Efficacy of fluticasone furoate nasal spray and levocetirizine in patients with Japanese cedar pollinosis subjected to an artificial exposure chamber

Should Intranasal Corticosteroids Be Used for the Treatment of Ocular Symptoms of Allergic Rhinoconjunctivitis? A Review of Their Efficacy and Safety Profile

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