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 with ≥2 year history of SAR from Mountain Cedar pollen. Subjects were randomized to CIC-HFA 74µg (N=226), CIC-HFA 148µg (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 74µg:N=187, CIC-HFA 148µg: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 74µg (P<0.0124) demonstrated statistically significant improvements and CIC-HFA 148µg demonstrated numerical improvements in overall RQLQ[S] (P-value not determined) and CIC-HFA 74µg and CIC-HFA 148µg 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 74µg or CIC-HFA 148µg demonstrated improvements in the rhinoconjunctivitis related quality of life in subjects with SAR to Mountain Cedar pollen.