Original Articles: Rhinitis, Sinusitis, Upper Airway Diseases
A placebo-controlled study of the nasal decongestant effect of phenylephrine and pseudoephedrine in the Vienna Challenge Chamber

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Background

Studies on the efficacy of phenylephrine in the treatment of nasal congestion have yielded inconsistent results, notwithstanding its approval for this indication.

Objective

To evaluate and compare the decongestant effect of a single dose of phenylephrine to placebo and pseudoephedrine in patients with seasonal allergic rhinitis.

Methods

This randomized, placebo-controlled, 3-way crossover study evaluated patient-scored nasal congestion, peak nasal inspiratory flow, and rhinomanometry at more than 6 hours in 39 grass-sensitive patients exposed to grass pollen in the Vienna Challenge Chamber. Patients were dosed with immediate-release formulations of phenylephrine, 12 mg, pseudoephedrine, 60 mg, as a control, or placebo.

Results

Phenylephrine was not significantly different from placebo in the primary end point, mean change in nasal congestion score at more than 6 hours (P = .56), whereas pseudoephedrine was significantly more effective than both placebo (P < .01) and phenylephrine (P = .01). Phase 1 results showed a difference between phenylephrine and placebo that was 64% of the difference between pseudoephedrine and placebo, substantially greater than the 17% difference observed for all phases. Carryover bias due to patient recall of the pseudoephedrine effect may have influenced these results. Rhinomanometry and peak nasal inspiratory flow results were consistent with these data. Neither phenylephrine nor pseudoephedrine had an effect on the nonnasal symptoms. No adverse events were reported in this study.

Conclusions

During a 6-hour observation period, a single dose of pseudoephedrine but not phenylephrine resulted in significant improvement in measures of nasal congestion. Neither phenylephrine nor pseudoephedrine had an effect on nonnasal symptoms.

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.

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