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.

Psychometric validation of the rhinitis control assessment test: a brief patient-completed instrument for evaluating rhinitis symptom control.

BACKGROUND: Allergic rhinitis is common, but a validated tool for comprehensive assessment of disease control is not available. OBJECTIVE: To develop a simple patient-completed instrument (the Rhinitis Control Assessment Test [RCAT]) to help detect problems with control of rhinitis symptoms. METHODS: During a visit to an allergy specialist, 410 patients with allergic rhinitis completed a Total Nasal Symptom Score (TNSS) assessment and the 26-item developmental RCAT. Physicians also completed a global assessment of rhinitis symptom control for each patient. RESULTS: Stepwise regression methods identified 6 items from the developmental RCAT (frequency of nasal congestion, sneezing, and watery eyes; sleep interference; activity avoidance; and self-assessed control) that were most predictive of the allergist's global rating of rhinitis symptom control. A summated rating scale from these 6 items showed good convergent validity (r > 0.70) with scale scores from the TNSS. The discriminant validity of the 6-item scale was demonstrated as mean RCAT scale scores differed significantly across groups of patients differing in physician-rated disease severity (F = 54.4), TNSS severity (F = 193.8), and physician-recommended change in therapy (F = 50.6) (P < .001 for all). CONCLUSIONS: The RCAT, a 6-item patient-completed instrument, has satisfactory psychometric properties and seems to be a valid tool for assessing control of allergic rhinitis. Further validation studies will provide confirmation.