Fluticasoni furoas

Pharmacotherapeutic group: nasal preparations, corticosteroids, ATC code: R01AD12 Mechanism of action Fluticasone furoate is a synthetic trifluorinated corticosteroid with very high affinity for the glucocorticoid receptor and a potent anti-inflammatory effect. Clinical efficacy and safety Seasonal allergic rhinitis in adults and adolescents Compared with placebo, intranasal fluticasone furoate 110 micrograms once daily significantly improved nasal symptoms (including rhinorrhoea, nasal congestion, sneezing and nasal itching) and ocular symptoms (including itching/burning, tearing/watering and redness of the eyes) in all four studies. Efficacy was maintained throughout the full 24-hour dosing interval with once-daily administration. Onset of therapeutic effect was observed as early as 8 hours after the initial dose, with further improvement seen over the following days. Fluticasone furoate nasal spray significantly improved patients' perception of overall response to treatment and disease-related quality of life (Rhinoconjunctivitis Quality of Life Questionnaire – RQLQ) in all four studies. Perennial allergic rhinitis in adults and adolescents Fluticasone furoate nasal spray 110 micrograms once daily significantly improved nasal symptoms as well as patients' perception of overall treatment response compared with placebo in three studies. Fluticasone furoate nasal spray 110 micrograms once daily significantly improved ocular symptoms and disease-related quality of life (RQLQ) compared with placebo in one study. Efficacy was maintained throughout the full 24-hour dosing interval with once-daily administration. In a two-year clinical study evaluating the long-term safety of fluticasone furoate (intranasal spray 110 micrograms once daily) in adults and adolescents with perennial allergic rhinitis receiving either fluticasone furoate (n = 367) or placebo (n = 181), the primary outcomes [time to progression of posterior subcapsular lens opacity (≥ 0.3 from baseline by LOCS III, Lens Opacities Classification System, version III) and time to elevation of intraocular pressure (IOP; ≥ 7 mmHg from baseline)] were not statistically significantly different between the two groups. Progression of posterior subcapsular lens opacity (≥ 0.3 from baseline) was more common in subjects treated with fluticasone furoate 110 micrograms [14 (4%)] than with placebo [4 (2%)] and was transient in ten subjects in the fluticasone furoate group and two in the placebo group. Elevation of IOP (≥ 7 mmHg from baseline) was more common in subjects treated with fluticasone furoate 110 micrograms: 7 (2%) on fluticasone furoate 110 micrograms once daily and 1 (< 1%) on placebo. These events were transient in six subjects in the fluticasone furoate group and one in the placebo group. At weeks 52 and 104, 95% of subjects in both treatment groups had posterior subcapsular lens opacity change within ± 0.1 of baseline in each eye, and at week 104 ≤ 1% of subjects in both groups had a change of ≥ 0.3 from baseline. At weeks 52 and 104, most subjects (> 95%) had IOP values within ± 5 mmHg of baseline. Changes in posterior subcapsular lens opacity or IOP were not accompanied by adverse events such as cataract or glaucoma. Paediatric population Seasonal and perennial allergic rhinitis in children The paediatric dosing rationale is based on evaluation of efficacy data across the population of children with allergic rhinitis. In seasonal allergic rhinitis, fluticasone furoate nasal spray 110 micrograms once daily was effective, but no significant differences were observed between fluticasone furoate nasal spray 55 micrograms once daily and placebo for any endpoint. In perennial allergic rhinitis, fluticasone furoate nasal spray 55 micrograms once daily showed a less consistent efficacy profile than fluticasone furoate nasal spray 110 micrograms once daily over 4 weeks of treatment. A post-hoc analysis at 6 and 12 weeks in the same study, as well as a 6-week HPA-axis safety study, supported the efficacy of fluticasone furoate nasal spray 110 micrograms once daily. A 6-week study evaluating the effect of fluticasone furoate nasal spray 110 micrograms once daily on adrenal function in children aged 2 to 11 years demonstrated no significant effect on the 24-hour serum cortisol profile compared with placebo. A randomised, double-blind, parallel-group, multicentre, one-year placebo-controlled growth study assessed the effect of fluticasone furoate nasal spray 110 micrograms once daily on growth velocity in 474 prepubertal children (girls aged 5 to 7.5 years and boys aged 5 to 8.5 years) measured by height. Mean growth velocity over 52 weeks of treatment was lower in patients receiving fluticasone furoate (5.19 cm/year) than placebo (5.46 cm/year). The mean treatment difference was –0.27 cm/year [95% CI –0.48 to –0.06]. Seasonal and perennial allergic rhinitis in children (under 6 years of age) Safety and efficacy studies were conducted in 271 patients aged 2 to 5 years with seasonal and perennial allergic rhinitis, of whom 176 were exposed to fluticasone furoate. Safety and efficacy in this age group have not been well established.