A study was performed to investigate the effects of mizolastine (MKC-431) on nasal symptoms induced by allergen challenge in 12 subjects with a history of Japanese cedar allergic rhinitis. All of the subjects received mizolastine (10mg p. d.) or placebo orally in a random, double-blind and crossover manner for 5 days at 3 week intervals. The subjects were challenged by exposure to cedar extract on the fifth day of administration. Changes in the following measurements were evaluated before and after the antigen challenge: total volume (left+right) of the nasal cavity measured by acoustic rhinometry, symptoms of nasal obstruction judged by subjects, number of eosinophils in nasal washings, and concentrations of chemoattractant in nasal lavage fluid.
The following results were obtained.
1) The volume of the nasal cavity at 1h after antigen challenge was significantly different between the mizolastine and placebo administration groups (p=0.032).
2) The number of eosinophils and the concentration of EPX, IL-16, LTB
4, PAF, and the amount of eotaxin mRNA in nasal lavage fluid was not significantly different between the mizolastine and placebo administration groups.
3) The total number of sneezes during the 30min period after antigen challenge was 0.58±0.79 (mizolastine) and 4.00±5.06 (placebo), showing a significant difference (p=0.038).
4) The symptom score for nasal obstruction at 0.5, 1, 7, 9, 10, 12h after antigen challenge was significantly different between the mizolastine and placebo administration groups.
5) Adverse events and abnormal changes in clinical laboratory findings related to the drug were not observed during the treatment period, although elevation of eosinophils was observed in one subject after the treatment period.
These results showed the effectiveness of mizolastine in the treatment of sneezing and nasal obstruction induced by antigen challenge during early phase reaction. Though no apparent conclusion was obtained from the volume of the nasal cavity, the symptom score indicated the effective reduction of nasal obstruction during the late phase reaction.
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