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

Study Overview
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Brief Summary
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This trial is a randomized, double-blind, two arms, multicenter, Phase III study of Berinert for treatment of ACE induced Angioedema. This study should show that 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. This study should also compare the time to onset of relief as defined by an at least one point reduction on the severity scale of ACE-induced angioedema with Berinert versus placebo.

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

Conditions
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Acute ACE-induced Angioedema

Intervention / Treatment
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* Drug: Berinert
* Drug: Clemastin
* Drug: Cortisone acetate
* Drug: NaCl


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Cortisone, Clemastin + BERINERT | Drug: Berinert<br> <br> Drug: Clemastin<br> <br> Drug: Cortisone acetate<br> <br> |
| Placebo Comparator: Group 2<br>Cortinsone, Clemastin + NaCl | Drug: Clemastin<br> <br> Drug: Cortisone acetate<br> <br> Drug: NaCl<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time of resolution | 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. | 07/2013 until 12/2014 |