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| |  AAAAI: Rofleponide Palmitate Nasal Spray Provides Less Symptom Control Than Budesonide in Controlled Setting By Bonnie Darves SAN FRANCISCO, CA -- March 23, 2004 -- The recently developed nasal glucocorticosteroid rofleponide palmitate appears to be slightly less effective than the standard budesonide treatment in doses up to 100 mcg in relieving symptoms of seasonal allergic rhinitis, according to a new study presented here at the American Academy of Allergy, Asthma & Immunology Annual Meeting. While 2 other recent studies have shown a slight advantage of rofleponide over budesonide in doses up to 200 mcg, this study, conducted in the controlled setting of an environmental exposure unit (EEU), did not find better symptom relief with rofleponide at comparable doses. In the study, equally randomised patients (age 16 and older with a mean age of 33 years) received rofleponide in one of three once-daily doses (20, 100 or 200 mcg), budesonide in a 128 mcg dose or placebo, Dr. Rafeiro said. Subjects underwent a 1- to 2-day washout period, and received the drug or placebo between 6 a.m. and 10 a.m. for 8 days. In the final 5 days, patients were challenged with ragweed pollen in the evening. "We found that rofleponide, an investigational drug, was simply not as effective as budesonide in this controlled setting of the environmental exposure unit," said co-author Elizabeth Rafeiro, PhD, Department of Allergy, Kingston General Hospital, Kingston, Ontario, Canada. The controlled conditions of the EEU in which the study's 291 patients were exposed to consistent levels of pollen may provide for a more accurate evaluation of drug efficacy than the community setting in which patient compliance and symptom reporting are less easily monitored. Only high doses of rofleponide -- 200 mcg -- provided symptom relief comparable to that of budesonide, she noted. Over the final 3 days of the challenge period, patients on 200 mcg of rofleponide had significant decreases in mean morning total nasal symptom scores (TNSS) (P= .007), but those on lower doses did not improve compared to those on placebo, and no dose of the drug effectively reduced evening TNSS. Budesonide-treated patients reported significantly reduced morning TNSS compared with placebo (P < .001) rofleponide 20 mcg (P < .001) and rofleponide 100 mcg (P = .009). However, both medications were well tolerated, and adverse events were comparable between the 2 treatment groups, with the exception of epistaxis, which occurred in 7% of patients on the 20 mcg dose of rofleponide compared with 2% of those on budesonide.
[Study title: A Comparison of Rofleponide Palmitate Nasal Spray (rofleponide) With Budesonide Aqueous Nasal Spray (budesonide) and Placebo for Seasonal Allergic Rhinitis (AR) Using the Environmental Exposure Unit (EEU). Poster 703]
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