Methods: Subjects with a ≥2 year history of SAR from Mountain Cedar pollen were randomized in a placebo-controlled, double-blind, parallel group, multicenter study to CIC-HFA 74µg (N=226), CIC-HFA 148µg (N=225), or placebo (N=220) once-daily in the morning for 2 weeks. Change from baseline in reflective total nasal symptom score (rTNSS, primary endpoint), instantaneous total nasal symptom score (iTNSS, a key secondary endpoint) and individual reflective and instantaneous nasal symptom scores of congestion, itching, sneezing, and runny nose averaged over the 2-week treatment period were evaluated. Treatment-emergent adverse events (TEAEs) were monitored throughout the study.
Results: CIC-HFA 74µg and CIC-HFA 148µg demonstrated a statistically significant improvement in rTNSS (P<0.0001) and iTNSS (P=0.0002) and improvements in the individual reflective and individual instantaneous nasal symptoms of congestion, nasal itching, sneezing, and runny nose (P<0.05 for all, unadjusted for multiplicity) from baseline. The overall incidence of TEAEs was low and comparable between the CIC treatment groups and placebo. Epistaxis was the most frequent TEAE reported by 3 (1.3%), 6 (2.7%), and 4 (1.8%) subjects in the CIC-HFA 74µg, 148µg, and placebo treatment group respectively.
Conclusions: In this study, once-daily treatment with CIC-HFA 74µg or CIC-HFA 148µg demonstrated statistically significant improvements in the nasal symptoms of SAR. Both active treatments were well tolerated.