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Fexofenadine/Pseudoephedrine Combination Has Rapid Onset in Seasonal Allergic Rhinitis: Presented at AAAAI

By Bonnie Darves

SAN FRANCISCO, CA -- March 24, 2004 -- Two parallel-group studies performed in an allergen exposure unit found that the antihistamine fexofenadine in combination with pseudoephedrine provides significant relief of moderate to severe symptoms of seasonal allergic rhinitis within 45 minutes and is safe and well tolerated, researchers report.

Results of the placebo-controlled studies, which included 784 primarily adults, were presented here at the American Academy of Allergy, Asthma & Immunology Annual Meeting. Lead author Robert Berkowitz, MD, Atlanta Allergy & Asthma Clinic, Atlanta, Georgia, United States, noted that the drug combination's safety profile was comparable to that of placebo, warranting its use in patients whose severe symptoms require fast-acting treatment.

The studies enrolled patients with a mean age of 33 years. For entry in the study, subjects had to have a minimum major symptom complex (MSC) score of 24. The MSC consisted of the sum of sneezing, itchy nose, runny nose, watery eyes, itchy eyes, itchy ears/throat and stuffy nose for each patient.

Patients received a combination of fexofenadine 60 mg and pseudoephedrine 120 mg or placebo at 9 a.m. and were exposed to allergen for 6 hours post-dose. Symptoms were recorded at 15-minute intervals up to 2 hours after dosing.

The researchers found that the median onset of action, as measured by reduction in MSC scores, was 45 minutes (P = .0079 versus placebo), and that MSC score reductions continued to compare favourably against placebo for up to 6 hours post-dose, with an onset of "clinically important relief" occurring a median of 60 minutes after dosing, Dr. Berkowitz said.

Although a total of 30 fexofenadine/pseudoephedrine patients in the 2 studies experienced adverse events, none were serious enough to warrant discontinuation of treatment.

The studies were funded by Aventis.


[Study Title: Fexofenadine HCl 60 mg/Pseudoephedrine HCl 120 mg Has a Rapid Onset of Action of 45 Minutes in Seasonal Allergic Rhinitis (SAR) Patients. Poster 700]

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