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document
Inhibition of histamine-induced skin wheal and flare after 5 days of mizolastine . Mizolastine is a new , nonsedating antihistamine providing satisfactory symptomatic relief in allergic rhinitis and urticaria . The purpose of this study was to use inhibition of wheal and flare formation after 2-mu g intradermal histamine injections as a measure of the antihistamine effect of repeated doses of mizolastine . Eight volunteers were enrolled in this four-arm , double-blind , cross-over , randomized study . Three dose levels of once-daily mizolastine ( 5 mg , 10 mg , and 15 mg ) were compared with placebo during 5-day dose periods . Histamine tests were performed before drug intake on days 1 and 5 , and then 2 , 3 , 4 , 6 , 8 , 10 , 12 , 14 , and 24 hours after drug intake on day 5 . All 3 doses of mizolastine were more effective than placebo in suppressing wheal and flare reactions , and the antihistamine activity was highest at both the 10- and 15-mg dose levels . The effect on the flare reaction appeared within 1 hour , reached a maximum effect 4 hours after administration , and persisted for as long as 24 hours . The relative changes in wheal and flare areas were correlated with mizolastine trough plasma levels on day 5 . Safety was satisfactory in all groups . This study confirms that mizolastine is a rapid and potent antihistamine ; and its long-lasting effectiveness indicates that a once-daily regimen is acceptable for clinical use .
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Intervention_Physical
histamine-induced
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Intervention_Pharmacological
mizolastine
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Intervention_Pharmacological
Mizolastine
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Intervention_Pharmacological
once-daily mizolastine
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Intervention_Control
placebo
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Intervention_Physical
Histamine tests
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Intervention_Pharmacological
mizolastine
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Intervention_Control
placebo
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Intervention_Pharmacological
mizolastine
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Intervention_Pharmacological
mizolastine
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Outcome_Physical
relief in allergic rhinitis and urticaria
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Outcome_Other
more effective
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Outcome_Physical
wheal and flare reactions
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Outcome_Physical
antihistamine activity
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Outcome_Physical
effect on the flare reaction
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Outcome_Other
Safety
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Outcome_Physical
antihistamine
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Participant_Condition
allergic rhinitis and urticaria
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Participant_Sample-size
Eight
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Participant_Condition
volunteers