Efficacy and safety of an oral formulation of cetirizine and prolonged-release pseudoephedrine versus budesonide nasal spray in the management of nasal congestion in allergic rhinitis.
BACKGROUND
The aim of this study was to compare the decongestant properties and tolerability of oral cetirizine and pseudoephedrine in a prolonged release form with those of nasal (aqueous spray) budesonide.


METHODS
Thirty-six individuals experiencing allergic rhinitis to house dustmites (HDM) participated in a study according to a randomized, crossover, two-period, two-treatment design with at least a 2-week washout period between treatments. In each period of 4 consecutive days, medications were taken twice daily. On day 1, immediately after the first intake of medication, individuals were exposed to HDM extract in the Vienna Challenge Chamber (VCC) for 5 hours. The primary efficacy parameter was nasal congestion, assessed by active anterior rhinomanometry and rating of nasal cavity photos.


RESULTS
Rhinomanometry and nasal cavity photos both indicated that cetirizine/pseudoephedrine efficacy was statistically superior to budesonide in the management of nasal congestion during VCC sessions. The efficacy of cetirizine/pseudoephedrine was similar to that of budesonide from the end of day 1 up to day 4 when individuals were exposed to their natural environment post exposure to the aeroallergens. This study confirms the efficacy of cetirizine/pseudoephedrine and budesonide in the management of nasal congestion associated with allergic rhinitis. Both medications were well-tolerated. Cetirizine/pseudoephedrine was more effective than budesonide during HDM exposure, whereas budesonide became as effective as cetirizine/pseudoephedrine several hours post exposure to the allergens.
Zieglmayer
Ursula P
UP
ENT - University Clinic Vienna, Vienna, Austria.
Horak
Friedrich
F
Toth
Josef
J
Marks
Bernhard
B
Berger
Uwe E
UE
Burtin
Bernard
B
D000281:Administration, Intranasal; D000284:Administration, Oral; D000328:Adult; D018926:Anti-Allergic Agents / Q000008:administration & dosage*; D019819:Budesonide / Q000008:administration & dosage*; D017332:Cetirizine / Q000008:administration & dosage*; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D004338:Drug Combinations; D004809:Ephedrine / Q000008:administration & dosage*; D005260:Female; D039563:Histamine H1 Antagonists, Non-Sedating / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D014663:Nasal Decongestants / Q000008:administration & dosage*; D012123:Pulmonary Ventilation; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy* / Q000503:physiopathology; D025363:Rhinomanometry
D018926:Anti-Allergic Agents; D003692:Delayed-Action Preparations; D004338:Drug Combinations; D039563:Histamine H1 Antagonists, Non-Sedating; D014663:Nasal Decongestants; D019819:Budesonide; D004809:Ephedrine; D017332:Cetirizine