Ocular safety of fluticasone furoate nasal spray in patients with perennial allergic rhinitis: a 2-year study.

BACKGROUND: This is the first study, to our knowledge, to evaluate the ocular effects of an intranasal corticosteroid during 2 years of treatment for perennial allergic rhinitis (PAR). OBJECTIVE: To assess ocular safety in adult and adolescent patients 12 years and older with PAR after 2 years of continuous treatment with fluticasone furoate nasal spray (FFNS), 110 µg once daily, and placebo. METHODS: This was a 2-year, randomized, double-blind, placebo-controlled study of once-daily FFNS, 110 ìg, and placebo in 548 patients 12 years and older with PAR. The primary ocular safety end points were time to first occurrence of an event for the Lens Opacities Classification System, Version III (LOCS III), posterior subcapsular opacity (PSO) and time to first occurrence of an event for intraocular pressure (IOP). RESULTS: On the basis of survival analyses, the difference between the treatment groups for time to first occurrence of a LOCS III PSO and time to first occurrence of an IOP event was not statistically significant (P = .39 and P = .34, respectively). Changes from baseline in visual acuity, LOCS III PSO, cortical opacity, LOCS III nuclear opacity and nuclear color, IOP, and horizontal cup-to-disc similar between treatment groups. There were no ophthalmic-related adverse events of LOCS III PSO or IOP that led to early withdrawal. The most common drug-related adverse event was epistaxis (FFNS, 28%; placebo, 14%). CONCLUSION: These data neither support nor negate current recommendations for regular ophthalmic monitoring in patients treated with intranasal corticosteroids. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00682643.

Comparison of patient preference for sensory attributes of fluticasone furoate or fluticasone propionate in adults with seasonal allergic rhinitis: a randomized, placebo-controlled, double-blind study.

BACKGROUND: Intranasal corticosteroids are first-line treatment for moderate-to-severe seasonal allergic rhinitis (AR). OBJECTIVES: To compare preferences for fluticasone furoate and fluticasone propionate nasal sprays after 1 week of treatment in patients with symptomatic seasonal AR. METHODS: Patients with seasonal AR were enrolled (n = 360) and randomized 1:1 to active treatment (fluticasone furoate, 110 microg, or fluticasone propionate, 200 microg, followed by crossover treatment for 1 week each) or matched placebo sequence with a 1-week washout before crossover dosing. Fluticasone furoate and fluticasone propionate efficacy was measured by change from baseline during 1 week in daily reflective total nasal symptom score (rTNSS) that assessed severity of rhinorrhea, nasal congestion, nasal itching, and sneezing. Patient preference for fluticasone furoate or fluticasone propionate was assessed at the end of the study by questionnaire. RESULTS: Three hundred sixty patients from 29 clinical sites in the Unites States were randomized and treated between August 1, 2007 and November 30, 2007. Most patients were white (73%) and female (59%), with a mean age of 38.3 years, and had had seasonal AR for at least 10 years (74%). Fluticasone furoate and fluticasone propionate each reduced the daily rTNSS compared with their respective placebos (least squares mean [SD] difference, -0.8 [0.24], P < .001, and -0.6 [0.24], P = .01, respectively). More patients (P < .001) preferred fluticasone furoate to fluticasone propionate based on attributes of scent or odor (58% vs 27%), aftertaste (60% vs 18%), leaking out of the nose and down the throat (59% vs 21%), and mist gentleness (57% vs 26%). No statistically significant differences were seen in preferences regarding ease of use, delivery method, or device comfort. CONCLUSION: Both fluticasone furoate and fluticasone propionate significantly improved symptoms in adult patients with seasonal AR. Most patients preferred the sensory attributes of fluticasone furoate to those of fluticasone propionate after 1 week of treatment.