A comparison of rofleponide palmitate nasal spray (RPNS) with budesonide aqueous nasal spray (BANS) and placebo for seasonal allergic rhinitis (AR) using the environmental exposure unit (EEU)

• Published in: Journal of allergy and clinical immunology 2004-02, Vol.113 (2), p.S202-S202
• Main Authors: Day, J.H., Briscoe, M., Rafeiro, E., Schrewelius, C., Simpson, B., O'Dowd, L.
• Format: Article
• Language: English
• ISSN: 0091-6749; 1097-6825
• DOI: 10.1016/j.jaci.2004.01.169

RPNS, a recently developed nasal glucocorticosteroid for AR, was compared to BANS with known efficacy for AR, and placebo, using the EEU, a controlled-pollen exposure setting. This double-blind, randomized, placebo-controlled, parallel-group study of 291 adults ≥16 years of age with seasonal (ragweed) AR evaluated 3 doses of RPNS (20, 100, 200 μg) with BANS (128 μg) and placebo once daily for 8 days (3 pretreatment days followed by 5 days consisting of 3 hour EEU challenge sessions). Primary efficacy variables were changes in morning and evening total nasal symptom score (TNSS) and peak nasal inspiratory flow (PNIF). Only the 200-μg dose of RPNS significantly reduced morning TNSS compared with placebo ( P=.007); no RPNS treatment group demonstrated significant differences in evening TNSS compared with placebo. However, BANS treatment significantly reduced morning TNSS compared with placebo ( P