5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Corticosteroids. ATC code: R01AD12
Fluticasone furoate is a synthetic trifluorinated corticosteroid that possesses a very high affinity for the glucocorticoid receptor and has a potent anti-inflammatory action.
Clinical experience:
Seasonal Allergic Rhinitis in adults and adolescents
Compared with placebo, fluticasone furoate nasal spray 110 micrograms once daily significantly improved nasal symptoms (comprising rhinorrhoea, nasal congestion, sneezing and nasal itching) and ocular symptoms (comprising itching/burning, tearing/watering and redness of the eyes) in all 4 studies. Efficacy was maintained over the full 24-hours dosing period with once daily administration.
Onset of therapeutic benefit was observed as early as 8 hours after initial administration, with further improvement observed for several days afterwards.
Fluticasone furoate nasal spray significantly improved the patients’ perception of overall response to therapy, and the patients’ disease-related quality of life (Rhinoconjunctivitis Quality of Life Questionnaire – RQLQ), in all 4 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 response to therapy compared to placebo in three studies.
Fluticasone furoate nasal spray 110 micrograms once daily significantly improved ocular symptoms as well as improving patients’ disease-related quality of life (RQLQ) compared to placebo in one study.
Efficacy was maintained over the full 24-hour dosing period with once daily administration.
Seasonal and perennial allergic rhinitis in children:
The paediatric posology is based on assessment of the efficacy data across the allergic rhinitis population in children.
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 on any endpoint.
In perennial allergic rhinitis, fluticasone furoate nasal spray 55 micrograms once daily exhibited a more consistent efficacy profile than fluticasone furoate nasal spray 110 micrograms once daily over 4 weeks’ treatment. Post-hoc analysis over 6 and 12 weeks in the same study, as well as 6-week HPA axis safety study, supported the efficacy of fluticasone furoate nasal spray 110 micrograms once daily.
A 6-week study that assessed the effect of fluticasone furoate nasal spray 110 micrograms once daily on adrenal function in children aged 2 to 11 years showed that there was no significant effect on 24-hour serum cortisol profiles, compared with placebo.
Results from a placebo-controlled knemometry study of fluticasone furoate nasal spray 110 micrograms once daily revealed no clinically relevant effects on short-term lower leg growth rate in children (6 to 11 years).
Seasonal and perennial allergic rhinitis in children (under 6 years):
Safety and efficacy studies were performed in a total of 271 patients from 2 to 5 years of age in both seasonal and perennial allergic rhinitis, of whom 176 were exposed to fluticasone furoate.
Safety and efficacy in this group has not been well established.
