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) - 25/08/11
Abstract |
Rationale |
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.
Methods |
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).
Results |
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<.001), RPNS 20 μg (P<.001), and RPNS 100 μg (P=.009), as well as evening TNSS compared with placebo (P=.003) and RPNS 20 μg (P=.001). No RPNS group significantly differed from placebo in either morning or evening PNIF, while BANS significantly increased morning and evening PNIF compared with placebo and RPNS 20 μg (P<.02 for both). Frequency of AEs was similar between all treatment groups; no serious AEs were reported.
Conclusion |
Rofleponide palmitate nasal spray was less effective than budesonide aqueous nasal spray 128 μg for the relief of symptoms of seasonal AR when compared with placebo and at doses up to 100 μg upon comparing both active medications. Both active medications were well tolerated.
Le texte complet de cet article est disponible en PDF. Funding: AstraZeneca |
Vol 113 - N° 2S
P. S202 - février 2004 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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