title: 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.
abstract: 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.
authors.affiliation: ENT - University Clinic Vienna, Vienna, Austria.
authors.forename: Ursula P
authors.initials: UP
authors.lastname: Zieglmayer
authors.forename: Friedrich
authors.initials: F
authors.lastname: Horak
authors.forename: Josef
authors.initials: J
authors.lastname: Toth
authors.forename: Bernhard
authors.initials: B
authors.lastname: Marks
authors.forename: Uwe E
authors.initials: UE
authors.lastname: Berger
authors.forename: Bernard
authors.initials: B
authors.lastname: Burtin
mesh_terms: 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
chemical_list: 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