Bilastine Updosing - Characterization of Underlying Mechanisms
Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
Summary
This is a double-blind, triple cross-over, placebo-controlled study to assess the efficacy,
mechanisms, and safety of treatment with the antihistamine bilastine in patients with cold
contact urticaria (CCU).
Efficacy is primarily assessed by a change in critical stimulation time thresholds (CSTT) and
critical temperature thresholds (CTT) after treatment with different dosages of bilastine (20
mg, 40 mg, 80 mg). Following a baseline period of 2-4 weeks, patients are randomized to
either group A or group B. In group A they are given bilastine 20 mg, 40 mg, placebo and
bilastine 80 mg for 7 days each followed by a 14-day washout period at a time. In group B
they are given bilastine 80 mg, placebo, 40 mg and 20 mg for 7 days each followed by a 14-day
washout period at a time. CSTT and CTT testings are performed at each of 6 visits, skin
microdialysis for the assessment of mast cell mediators is performed at V2, V3 and V6. Visits
for investigator's assessments are scheduled at day -14 to -28, day 0, day 7, day 28, day 49,
and day 70. Overall a max. of 20 subjects with cold contact urticaria will be enrolled.