Effects of rupatadine vs placebo on allergen-induced symptoms in patients exposed to aeroallergens in the Vienna Challenge Chamber

Ann Allergy Asthma Immunol. 2006 Jan;96(1):37-44. doi: 10.1016/S1081-1206(10)61038-1.


Background: Rupatadine is a novel compound with potent dual antihistamine and platelet-activating factor antagonist activities and no sedative effects.

Objective: To evaluate the efficacy of rupatadine, 10 mg once daily, and placebo on allergen-induced symptoms (including nasal congestion), nasal airflow, nasal secretion, and subjective tolerability in response to grass pollen in a controlled allergen-exposure chamber.

Methods: In a randomized, double-blind, placebo-controlled, crossover trial, 45 patients with a history of seasonal allergic rhinitis received rupatadine or placebo every morning for 8 days in 2 different periods separated by a 14-day washout interval. On day 8 of each crossover period, patients underwent a 6-hour allergen exposure in the Vienna Challenge Chamber, where a constant and homogeneous concentration of aeroallergens was maintained. Subjective and objective assessments were performed online during the exposure.

Results: Subjective single and composite nasal and nonnasal symptoms were consistently less severe with rupatadine use than with placebo use starting from the first evaluation at 15 minutes to the end of the 6-hour Vienna Challenge Chamber challenge, with the most significant effects seen for nasal rhinorrhea, nasal itching, sneezing attacks, and total nasal symptoms (P < .001 for all). All the other symptoms (including nasal congestion, P < or = .005) were also significantly reduced with active treatment compared with placebo use. Mean secretion weights and overall feeling of complaint were significantly lower with rupatadine therapy than with placebo use (P < or = .001). Overall, rupatadine treatment was well tolerated.

Conclusion: Rupatadine treatment is effective and well tolerated in patients with allergen-induced symptoms exposed to aeroallergens in a controlled exposure chamber.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Antigens, Plant / immunology
  • Cross-Over Studies
  • Cyproheptadine / adverse effects
  • Cyproheptadine / analogs & derivatives*
  • Cyproheptadine / therapeutic use
  • Dactylis / immunology
  • Double-Blind Method
  • Female
  • Histamine H1 Antagonists, Non-Sedating / adverse effects
  • Histamine H1 Antagonists, Non-Sedating / therapeutic use*
  • Humans
  • Inhalation Exposure
  • Male
  • Middle Aged
  • Nasal Mucosa / immunology
  • Nasal Mucosa / metabolism
  • Placebos
  • Pollen / immunology
  • Rhinitis, Allergic, Seasonal / drug therapy*
  • Rhinitis, Allergic, Seasonal / immunology
  • Sneezing / drug effects


  • Antigens, Plant
  • Histamine H1 Antagonists, Non-Sedating
  • Placebos
  • rupatadine
  • Cyproheptadine