Methods: Subjects ≥12 years of age with a ≥2 year history of PAR were randomized in a placebo-controlled, double-blind, parallel group, multicenter study to CIC-HFA 74µg (N=298), CIC-HFA 148µg (N=505), or placebo (N=307) QD AM for 26 weeks. Subject-reported change from baseline in reflective total nasal symptom score (rTNSS) and instantaneous total nasal symptom score (iTNSS) averaged every 2 weeks over the 26 weeks of the treatment period were secondary endpoints and were calculated as a sum of the individual nasal symptoms of congestion, runny nose, sneezing, and nasal itching. Change from baseline in the individual reflective and instantaneous nasal symptom scores averaged every 2 weeks over the 26 weeks of treatment period were also evaluated. Treatment-emergent adverse events (TEAEs) were assessed throughout the study.
Results: CIC-HFA 74µg and CIC-HFA 148µg doses demonstrated improvement in rTNSS (LS mean change 0.65 & 0.52 respectively, P≤0.01 for both), iTNSS (LS mean change 0.51 & 0.42 respectively, P≤0.05 for both), and improvements in the individual reflective and instantaneous nasal symptoms (P≤0.05 for all except instantaneous sneezing for the CIC-HFA 74μg dose) at 26 weeks from baseline. P-values were unadjusted for multiplicity. The overall incidence of TEAEs was comparable between the CIC-HFA treatment groups and placebo. The most frequently reported TEAEs (≥5% of subjects in any treatment group) were headache, nasopharyngitis, upper respiratory tract infections, viral upper respiratory tract infections, sinusitis, and epistaxis.
Conclusions: In this study, once-daily treatment with CIC-HFA 74µg or CIC-HFA 148µg demonstrated improvements in the nasal symptoms of PAR. Both active treatments were well tolerated.