Results of the Rhinoconjunctivitis Related Quality of Life Questionnaire Administered to Subjects with Seasonal Allergic Rhinitis Following Treatment with Ciclesonide Hydrofluoroalkane Nasal Aerosol

RATIONALE: Ciclesonide hydrofluoroalkane nasal aerosol (CIC-HFA) is currently in development as a treatment for allergic rhinitis. Improvement in the rhinoconjunctivitis related quality of life associated with seasonal allergic rhinitis (SAR) was measured by the rhinoconjunctivitis quality of life questionnaire with standardized activities (RQLQ[S]) in subjects ≥12 years of age randomized to CIC-HFA or placebo. METHODS: Data was collected as part of a placebo-controlled, double-blind, parallel group, multicenter study during the Texas Mountain Cedar pollen season in subjects randomized to CIC-HFA 80μg (N=226), CIC-HFA 160μg (N=225), or placebo (N=220) once-daily in the morning for 2 weeks. Change in RQLQ[S] scores was recorded for the intent-to-treat population and calculated in subjects with baseline RQLQ[S] ≥3.0 (CIC-HFA 80μg:N=187, CIC-HFA 160μg:N=183, placebo:N=183). The RQLQ[S] was self-administered by subjects prior to randomization and at the end of the double-blind study medication period. Change from baseline in overall RQLQ[S], a key secondary endpoint, and in the individual domains of activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, emotional, and eye symptoms over the 2-week treatment period were evaluated. RESULTS: CIC-HFA 80μg (P<0.0124) demonstrated statistically significant improvements and CIC-HFA 160μg demonstrated numerical improvements in overall RQLQ[S] (P-value not determined) and CIC-HFA 80μg and CIC-HFA 160μg demonstrated numerical improvements in individual domains of RQLQ[S] (P<0.05 for all, unadjusted for multiplicity) compared to placebo over the 2-week treatment period. CONCLUSIONS: In this study, once-daily treatment with CIC-HFA 80μg or CIC-HFA 160μg demonstrated improvements in the rhinoconjunctivitis related quality of life in subjects with SAR to Mountain Cedar pollen.