Original Articles: Rhinitis, Sinusitis, Upper Airway DiseasesA placebo-controlled study of the nasal decongestant effect of phenylephrine and pseudoephedrine in the Vienna Challenge Chamber
Section snippets
INTRODUCTION
In several recent surveys of impact and burden of allergic rhinitis, nasal congestion was consistently ranked the most bothersome symptom in both adult respondents and guardians of children with allergies.1, 2, 3 In addition, nasal congestion was the symptom that most respondents (50% of adults and 63% of guardians of children with allergies) wanted to prevent from occurring.3 Therapeutic options for the prevention and treatment of nasal congestion include oral decongestants (sympathomimetic
METHODS
This was a single-center, randomized, placebo-controlled, 3-way crossover study of the decongestant effect of phenylephrine compared with placebo and pseudoephedrine in patients with at least a 2-year history of symptomatic and skin test positive seasonal allergic rhinitis to grass pollen after exposure to grass pollen in the Vienna Challenge Chamber. Patients were to be treated with 1 dose of phenylephrine, 12 mg, pseudoephedrine, 60 mg, or placebo at each treatment visit with a minimum
RESULTS
Thirty-nine patients were randomized; 38 patients completed treatment, and 1 patient discontinued participation in the study for reasons unrelated to treatment with study drug after the first dose (pseudoephedrine). Patients were predominantly white (97%) and female (59%); age ranged from 19 to 46 years (mean, 27 years). Baseline (at the time the patients qualified) nasal congestion scores were 2.20 for phenylephrine and placebo and 2.26 for pseudoephedrine.
Phenylephrine was not significantly
DISCUSSION
In this study, statistical significance (P = .56) was not observed for the primary efficacy variable, the average change from baseline during a 6-hour evaluation period in nasal congestion, in patients with seasonal allergic rhinitis treated with a single dose of phenylephrine, 12 mg, vs patients treated with placebo. Comparatively, treatment with a single dose of pseudoephedrine, 60 mg, showed significant improvement in nasal congestion compared with placebo (P < .01) and phenylephrine (P =
ACKNOWLEDGMENTS
We thank Sandria De Sapio and Karin Gansch for study monitoring; Lucy Shneyer, MS, for statistical oversight; and Craig Ostroff, PharmD, for logistical and regulatory support.
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Funding Sources: This study was supported by a grant from Schering-Plough Research Institute.
Trial Registration: clinicaltrials.gov Identifier: NCT00276016
Disclosures: Drs Danzig, Yao, and Staudinger are employees of Schering-Plough Research Institute.