A comparison of rofleponide palmitate nasal spray (RPNS) with placebo and mometasone furoate nasal spray (MFNS) in adolescent and adult patients with seasonal (mountain cedar) allergic rhinitis (AR)

Abstract

Rationale Rofleponide palmitate, a glucocorticosteroid, was developed into an aqueous nasal spray for treatment of AR symptoms. The aim of this study was to evaluate the efficacy of RPNS compared with placebo and MFNS, a reference standard, in relieving symptoms of seasonal AR. Methods In this multicenter, randomized, double-blind, placebo-controlled, parallel group study, 660 adults and adolescents ≥12 years of age with seasonal (mountain cedar) AR were treated with 1 of 3 concentrations of RPNS (20, 100, and 200 μg), matching placebo, or MFNS (200 μg) once daily for 2 weeks. Assessments included changes in morning and evening total nasal symptom score (TNSS), morning total instantaneous symptom score (TISS), and the monitoring of adverse events (AEs). Results Two doses of RPNS significantly reduced morning and evening TNSS (20 μg, P<.05 for both; 200 μg, P<.001 for both) compared with placebo, while all 3 doses of RPNS significantly reduced morning TISS compared with placebo (20 μg, P=.007; 100 μg, P=.025; 200 μg, P<.001). The magnitude of improvement in TNSS and TISS observed with the 20- and 100-μg doses of RPNS were numerically similar to the MFNS group, while the magnitude of improvement with the 200-μg dose of RPNS was numerically higher than the MFNS group. The frequency of AEs was similar among all groups. Conclusion All treatments were well tolerated, and the 200-μg dose of RPNS was significantly more effective than placebo and had a higher magnitude of improvement than MFNS 200 μg in relieving mountain cedar AR symptoms in adolescent and adults patients.