Randomized, Double-blind, Two Arms, Multicenter, Phase III Study of Berinert for Treatment of ACE Induced Angioedema

• Berinert (Drug)
• Clemastin (Drug)
• Cortisone acetate (Drug)
• NaCl (Drug)

Primary outcomes

• time of resolution [07/2013 until 12/2014]: Berinert shortens the time to complete resolution of signs and symptoms of acute ACE-induced angioedema of the upper airway tract compared to placebo when given on top of standard treatment.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Written informed consent to participate in the study and ability to fulfil all study requirements
* Male or female patients aged >=18 years
* Patients with ACE induced angioedema (grade II-III) with imminent airway obstruction admitted to an Emergency department
* Patient is being treated with ACEi
* Patient must have acute angioedema attack caused by ACEi
* Treatment should be administered within 10 hours after onset of the angioedema
* Patients with angioedema of the head and/or neck (face, lips, cheeks, tongue, soft palate/uvula, pharynx and larynx)
* Male participants and female participants who are not capable of bearing children or who use a method of contraception that is medically approved by the health authority of the respective country
* Signed patient information consent form

Exclusion Criteria:

* Diagnosis of angioedema of other genesis: e.g. hereditary angioedema, C1-inhibitor deficiency, allergic edema, anaphylaxis, insect bite, trauma, abscess, local inflammation, local tumour, post-operative or post-radiogenic edema, salivary gland disorders
* Participation in a clinical study in the past 30 days
* Patients with simultaneous itchiness of skin (acute urticaria)
* Patients with a history of angioedema before taking ACEi
* History of hypersensitivity to any of the study drugs or medicine with a similar chemical structure.
* Pregnancy and/or breastfeeding
* Mental retardation of the patient with restriction of general judgment and awareness
* History of drug abuse (including alcohol and alcoholic liver disorders)
* Potentially unreliable patients
* Patients who are not suitable for the study in the opinion of the investigator

• Murat Bas, Dr., Principal investigator, Klinikum rechts der Isar