Efficacy and safety relative to placebo of an oral formulation of cetirizine and sustained‐release pseudoephedrine in the management of nasal congestion

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Abstract
Background The aim of this study was to assess the clinical efficacy of an oral formulation of cetirizine 5 mg with sustained‐release pseudoephedrine (PSE) 120 mg relative to placebo in patients with nasal congestion. Methods Twenty‐four patients with perennial rhinitis due to house‐dust‐mite (HDM) allergy were recruited in this crossover study. A treatment period of 1 week, in which cetirizine/PSE was administered twice daily, was followed by a washout period of at least 2 weeks and a further period of 1 week in which the alternative treatment was given to each patient. Immediately after the first dose of each medication (day 1), nasal congestion and related symptoms were assessed during a 7‐h challenge with HDM feces, with the Vienna Challenge Chamber (VCC), to investigate onset of action of the preparation. A second challenge of 3‐h duration, carried out at least 12 h after the final dose, was undertaken after 1 week (mean) of twice‐daily treatment to assess residual effects of the formulation after achievement of steady state. Results The oral formulation of cetirizine/PSE was significantly (p Conclusions In this study, cetirizine/PSE relieved nasal congestion and other objective and subjective symptoms to a significantly greater extent than placebo. No serious adverse events occurred, and both regimens were equally well tolerated.