D. Atkinson, T. Uryniak, B. Simpson
Feb 1, 2004
Citations
1
Influential Citations
3
Citations
Quality indicators
Journal
The Journal of Allergy and Clinical Immunology
Abstract
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 P P =.007; 100 μg, P =.025; 200 μg, P 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.