Safety Study of Levocetirizine and Fexofenadine
Condition: Pruritus; Chronic Urticaria; Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Pruritus; Urticaria; Chronic Urticaria
Study type: Interventional
Phase: Phase 4

Summary: 
      This Study is to comparison of Efficacy and Consistency of Action of Levocetirizine 5 mg once
      daily with Fexofenadine 60 mg twice daily in the histamine induced wheal, flare and itch
      Response.
    

Detailed description: 
      This will be a randomized, double-blind, placebo-controlled study with intra-individual
      comparison of the histamine induced wheal and flare reaction. In September 2009, Fexofenadine
      was approved as an antihistamine against allergies in Japan and it is currently used widely.
      It has been approved in 120 countries, including the US, UK, France and Germany [11]. In
      Europe and the United States, fexofenadine is marketed at 120 mg once daily for allergic
      rhinitis and 180mg once daily for urticaria. In Japan, fexofenadine is marketed at 60 mg
      twice daily for both conditions. But is this dosage regimen as effective as levocetirizine, 5
      mg once daily? The above described study from Takahashi et al, comparing 60 mg twice daily
      versus cetirizine 10 mg once daily suggests that it is not [4]. The aim of the study is to
      compare the efficacy and consistency of action of levocetirizine 5 mg once daily with
      fexofenadine 60 mg twice daily over a 24 hour period in the histamine induced wheal, flare
      and itch response. Furthermore, we would like to investigate whether a different between
      Japanese and Caucasian exists or not. Each volunteer will receive the study medication at
      time point 0 and 12 hour later. Skin Prick Test (SPT) will be performed in each volunteer
      using histamine (10 mg/ml), 15 minutes before drug admission (baseline) and at 0.5, 1, 2, 3,
      4, 6, 8, 10, 12 and 24 hours afterwards. Volumetric optical scanning system and infrared
      camera will be used for objective evaluation of the wheal- and flare reduction. Additionally,
      measurement of the erythema diameter with a transparent ruler will be performed. The
      subjective intensity of itching will be assessed using a Visual Analogue Scale (VAS). To
      relate the pharmacokinetics of the drugs to their pharmacodynamics, blood samples for assay
      of drug concentrations will be taken at baseline and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24
      hours later. Subjects will undergo the same procedure on three separate occasions to receive
      each treatment option. The options are: placebo at time 0 hours + placebo at 12 hours,
      Levocetirizine 5mg at time 0 hours + placebo at 12 hours or fexofenadine 60mg at time 0 hours
      + fexofenadine 60mg at 12 hours. There will be a washout period of at least 6 days between
      the treatments.
    

Intervention name(s): Levocetirizine Oral Tablet; Fexofenadine 60 Mg Oral Tablet; Placebo Oral Tablet
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Telfast; Lichtenstein
Intervention MeSH terms: Fexofenadine; Levocetirizine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment