A Study to Assess and Compare the Effects of 5 mg vs. 20 mg Desloratadine on the Development of Cold Urticaria Lesions

Inclusion criteria

• Outpatients with ACU for more than 6 weeks. Urticaria symptoms must comprise wheal and itch.
• History of beneficial effects of antihistaminic treatment.
• Age between 18 and 75 years.
• Female patients must be using a highly effective method of birth control (such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence,vasectomised partner), 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 ACU
• The presence of permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhoea diseases, congenital malformations or surgical mutilations of 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)
• History of adverse reactions to DL, loratadine, or other ingredients of the IMP
• Presence of active cancer which requires chemotherapy or radiation therapy
• Presence of acute urticaria, angioedema, or larynx edema
• History or presence of alcohol abuse or drug addiction
• Participation in any clinical trial within 4 weeks prior to enrolment
• Commitment to an institution in terms of § 40 Abs. 1 Nr. 4 AMG
• Intake of antihistamines or leukotriene antagonists within 7 days prior to the beginning of the study
• Intake of oral corticosteroids 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