Clinical trial NCT00521170: Wheal and Flare Reaction During 24 Hours in Allergic Volunteers.
Official title: Randomized, Monocenter, Double Blind, Placebo-controlled, Single Oral Dose, Three-way Cross Over Study, to Compare Levocetirizine and Desloratadine on Allergen-induced Wheal and Flare Reaction During 24 Hours in 18 Adult Allergic Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Allergy
Keywords: Levocetirizine
Wheal and flare
Allergic
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2007-08-27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Compare the activity of 5 mg levocetirizine and 5 mg desloratadine on allergen-induced wheal and flare reaction.


Eligibility criteria: Inclusion Criteria:

* Male and female allergic volunteers: Diagnosed allergy based on medical history and on positivity to skin tests to at least one of the standardized allergen including grass pollens, tree pollens, house dust mites, cat and dog dander and with a positive RAST for the specific selected allergen ≥ class 2

Exclusion Criteria:

* Pregnancy or lactating females, or females with childbearing potential without reliable contraception
* History or presence of any chronic or acute illness or disorder capable of altering the absorption, metabolism or elimination of drugs, or constituting a risk factor when taking the trial medication
* Heavy caffeine drinker (\> 5 cups of coffee, tea, cola, etc ... per day)
* Any drug treatment, including prescribed or non-prescription medicines (except hormonal contraceptives or post-menopausal hormonal replacement therapy for females and occasional use of paracetamol not exceeding 2 g/day with a maximum dose of 10 g per 14 days), taken from 14 days before study drug administration; the wash-out period after intake of systemic corticosteroids is at least 4 weeks
* Known allergy/intolerance to the study drug or any medicine chemically related to study drug or its excipients (lactose, cellulose...)
* Participation in another clinical trial, blood donation or significant blood loss (\> 450 mL) less than 12 weeks before the study drug administration
* Skin irritant or 48 hours UV exposure before each visit
* Immunotherapy received during the current year
* Any clinical conditions that, in the opinion of the Investigator, would make the subject unsuitable for the trial

Primary outcomes:
measure: Compare the activity of levocetirizine and desloratadine on allergen-induced wheal and flare reaction. Response to allergen administered by skin prick test (SPT) measured by the wheal and flare surface areas
timeFrame: 15 minutes
Secondary outcomes:
measure: Compare the AUC from pre-dose to 24 hours post-dose between levocetirizine and placebo and between desloratadine and placebo obtained for wheal and for flare areas. Compare the AUC from pre-dose to 12 hours post-dose
Other outcomes:
Locations:
city: Illkirch
country: France
city: Strasbourg
country: France
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: