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 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<0.001) superior to placebo in improving nasal obstruction during both challenges. The improvement in nasal airflow and nasal patency was significantly greater with cetirizine/PSE than with placebo (P<0.02). In addition, subjective assessment of nasal symptoms showed that cetirizine/PSE was significantly superior to placebo in both challenges for the sum of nasal obstruction scores (P<0.01). Both medications were well tolerated, and no serious adverse events occurred during the study.


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.
Horak
F
F
ENT-Universitätsklinik Wien, Vienna, Austria.
Toth
J
J
Marks
B
B
Stübner
U P
UP
Berger
U E
UE
Jäger
S
S
Burtin
B
B
Duby
C
C
D000284:Administration, Oral; D000293:Adolescent; D000316:Adrenergic alpha-Agonists / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D000485:Allergens / Q000009:adverse effects; D000818:Animals; D039741:Antigens, Dermatophagoides; D001794:Blood Pressure; D017332:Cetirizine / Q000009:adverse effects / Q000627:therapeutic use*; D002626:Chemistry, Pharmaceutical; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004809:Ephedrine / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006023:Glycoproteins / Q000009:adverse effects; D006634:Histamine H1 Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008925:Mites; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy* / Q000209:etiology; D012449:Safety; D013147:Spirometry
D000316:Adrenergic alpha-Agonists; D000485:Allergens; D039741:Antigens, Dermatophagoides; D003692:Delayed-Action Preparations; D006023:Glycoproteins; D006634:Histamine H1 Antagonists; D004809:Ephedrine; D017332:Cetirizine