Effects of 5 mg vs. 20 mg Desloratadine on Skin Lesions in Patients With Chronic Urticaria (CU)

Inclusion criteria

• Outpatients with moderate to severe CU for more than 6 weeks. Urticaria symptoms must comprise wheal and itch.
• Patients must exhibit spontaneous urticaria lesions in the randomization visit.
• History of beneficial effects of antihistaminic treatment.
• Age between 18 and 60 years.
• Female patients must be using adequate contraceptive precautions (highly effective method), or they must be postmenopausal, surgically sterilised, or hysterectomised (for details please see protocol).
• Female patients must be using adequate contraceptive precautions (contraceptive pill, depot, double barrier methods), or they must be postmenopausal, surgically sterilised, or hysterectomised.
• Voluntarily signed written informed consent.

Exclusion criteria

• The presence of permanent severe diseases, especially those affecting the immune system, except CU.
• The presence of permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhea diseases, congenital malformations or surgical mutilations of the gastrointestinal tract).
• History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia.
• History or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy.
• Evidence of severe renal dysfunction
• Evidence of significant hepatic disease (liver enzymes twice the upper reference value).
• The presence of galactose intolerance, lapp lactase deficiency or glucose galactose malabsorption.
• History of adverse reactions including hypersensitivity to DL and Loratadine.
• Intake of medicaments that could cause QT changes (drugs listed on www.qtdrugs.org).
• Presence of active cancer which requires chemotherapy or radiation therapy.
• Presence of acute urticaria / angioedema including laryngeal edema
• History or presence of alcohol abuse or drug addiction.
• Participation in any clinical trial within 4 weeks prior to enrolment.
• Intake of oral corticosteroids or other immunosuppressive therapy within 14 days prior to the beginning of the study.
• Use of depot corticosteroids or chronic systemic corticosteroids within 21 days before beginning of the study.
• Pregnancy or breast-feeding.
• Existing or planned placement in an institution after ruling according to § 40 passage 1 number 4 AMG (Arzneimittelgesetz).