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

Technical University of Munich

Status and phase: Completed; Phase 3

Conditions: Acute ACE-induced Angioedema

Treatments: Drug: NaCl; Drug: Cortisone acetate; Drug: Berinert; Drug: Clemastin

Study type: Interventional

Funder types: Other

Identifiers

NCT01843530

BER-1272-0058-I

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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31 participants in 2 patient groups, including a placebo group

Group 1

Experimental group

Description:

Cortisone, Clemastin + BERINERT

Treatment:

Drug: Cortisone acetate

Drug: Berinert

Drug: Clemastin

Group 2

Placebo Comparator group

Description:

Cortinsone, Clemastin + NaCl

Treatment:

Drug: NaCl

Drug: Cortisone acetate

Drug: Clemastin