Evaluation of the efficacy and safety of olopatadine and fexofenadine compared with placebo in Japanese cedar pollinosis using an environmental exposure unit.

Second-generation oral H1-antihistamines have become a mainstay of treatment for the symptoms of seasonal allergic rhinitis; however, the effect of olopatadine has not been widely reported to date.
To evaluate the efficacy of 2 oral H1-antihistamines, olopatadine and fexofenadine, in the treatment of the nasal symptoms of Japanese cedar pollinosis and their possible side effects.
This was a randomized, double-blind, placebo-controlled, crossover study conducted in an environmental exposure unit (EEU). Twenty volunteers suffering from Japanese cedar pollinosis were randomly divided into 3 groups and exposed to cedar pollen in the EEU with oral administration of olopatadine hydrochloride (5 mg), fexofenadine hydrochloride (60 mg), or placebo 1 hour prior to pollen exposure. Nasal symptoms, activity impairment, and subjective sleepiness were self-assessed during the study period. Attention was measured using the digit cancellation test. The trial was repeated after 4 and 7 weeks.
Compared with placebo, olopatadine significantly improved nasal symptoms and activity impairment during pollen exposure (P < .05). There was no significant relief of nasal discharge or nasal congestion with fexofenadine throughout the 5-hour exposure to cedar pollen. Furthermore, olopatadine significantly reduced nasal congestion during the first 2 hours, as well as sneezing and nasal discharge 4 hours after admission to the EEU compared with fexofenadine (P < .05). There was no significant difference in the effect on subjective sleepiness among the 3 groups, and all 3 agents had little effect on attention.
These findings suggest that olopatadine is more effective than placebo and fexofenadine in improving nasal symptoms of Japanese cedar pollinosis.
AuthorsT Enomoto, H Q Lu, M Yin, T Sakoda, Y Dake, K Enomoto, T Ide, L Cheng
JournalJournal of investigational allergology & clinical immunology (J Investig Allergol Clin Immunol) Vol. 19 Issue 4 Pg. 299-305 ( 2009) ISSN: 1018-9068 [Print] Spain
PMID19639726 (Publication Type: Journal Article, Randomized Controlled Trial)
Chemical References
  • Allergens
  • Dibenzoxepins
  • Histamine H1 Antagonists, Non-Sedating
  • Olopatadine Hydrochloride
  • Terfenadine
  • fexofenadine
  • Adult
  • Allergens (immunology)
  • Cryptomeria (immunology)
  • Dibenzoxepins (administration & dosage, adverse effects)
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Histamine H1 Antagonists, Non-Sedating (administration & dosage, adverse effects)
  • Humans
  • Male
  • Middle Aged
  • Motor Activity (drug effects, immunology)
  • Olopatadine Hydrochloride
  • Pollen (immunology)
  • Rhinitis, Allergic, Seasonal (drug therapy, immunology)
  • Sleep (drug effects)
  • Sneezing (drug effects)
  • Terfenadine (administration & dosage, adverse effects, analogs & derivatives)
  • Treatment Outcome

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