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

Sponsor
Technische Universität München (Other)
Overall Status
Completed
CT.gov ID
NCT01843530
Collaborator
(none)
31
Enrollment
4
Locations
2
Arms
70.9
Duration (Months)
7.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
31 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Randomized, Double-blind, Two Arms, Multicenter, Phase III Study of Berinert for Treatment of ACE Induced Angioedema
Study Start Date :
Nov 1, 2013
Actual Primary Completion Date :
Oct 5, 2018
Actual Study Completion Date :
Sep 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1

Cortisone, Clemastin + BERINERT

Drug: Berinert

Drug: Clemastin

Drug: Cortisone acetate
Placebo Comparator: Group 2

Cortinsone, Clemastin + NaCl

Drug: Clemastin

Drug: Cortisone acetate

Drug: NaCl

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kath. Klinikum Bochum, Med. Klinik III Bochum Germany 44787
2 Ludwig-Maximilian-Universität München Germany 81377
3 Klinikum rechts der Isar, Hals-Nasen-Ohren Klinik München Germany 81675
4 Universitätsklinikum Ulm, HNO Ulm Germany 89070

Sponsors and Collaborators

  • Technische Universität München

Investigators

  • Principal Investigator: Murat Bas, Dr., Klinikum rechts der Isar

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT01843530
Other Study ID Numbers:
  • BER-1272-0058-I
First Posted:
Apr 30, 2013
Last Update Posted:
Oct 22, 2020
Last Verified:
Oct 1, 2020
Additional relevant MeSH terms:
Angioedema
Cortisone

Study Results

No Results Posted as of Oct 22, 2020