EFFICACY AND SAFETY RELATIVE TO PLACEBO OF AN ORAL FORMULATION OF CETIRIZINE AND SUSTAINED-RELEASE PSEUDOEPHEDRINE IN THE MANAGEMENT OF NASAL CONGESTION

Background The aim of this study was to assess the clinical efficacy o f an oral formulation of cetirizine 5 mg with sustained-release pseudo ephedrine (PSE) 120 mg relative to placebo in patients with nasal cong estion. Methods Twenty-four patients with perennial rhinitis due to ho use-dust-mite (HDM) allergy were recruited in this crossover study. A treatment period of 1 week, in which cetirizine/PSE was administered t wice 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 resi dual effects of the formulation after achievement of steady state. Res ults The oral formulation of cetirizine/PSE was significantly (P<0.001 ) superior to placebo in improving nasal obstruction during both chall enges. The improvement in nasal airflow and nasal patency was signific antly greater with cetirizine/PSE than with placebo (P<0.02). In addit ion, subjective assessment of nasal symptoms showed that cetirizine/PS E was significantly superior to placebo in both challenges for the sum of nasal obstruction scores Both medications were well tolerated, and no serious adverse events occurred during the study.Conclusions In th is study, cetirizine/PSE relieved nasal congestion and other objective and subjective symptoms to a significantly greater extent than placeb o. No serious adverse events occurred, and both regimens were equally well tolerated.