AMelioration of Angiotensin Converting Enzyme Inhibitor Induced Angioedema Study

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter study recruiting patients with angioedema induced by ACEI.

Open-label treatment with subcutaneous Icatibant compared to a historic group of 47 patients with ACE inhibitor induced angioedema which the investigators have been previously treated in the investigators centers with current "standard" therapy (250 mg methylprednisolon and 2 mg clemastine).

In cases with fast progression of edema after application the study-drug, a second application with icatibant could be necessary. Rescue medication and intervention.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Technische Universität München
• Treatments: Angiotensin-Converting Enzyme Inhibitors; Bradykinin; Bradykinin B2 Receptor Antagonists; Cortisone; Icatibant

Criteria

Inclusion Criteria:

• Age >= 18 <85 years

• Patient is currently treated with an ACEI

• Patient must have acute angioedema attack caused by an ACEI

• Treatment should be administrated within 10 hrs after onset by an ACEI

• Patient with angioedema of head and /or neck (face, lips, cheeks, tongue, soft palate/uvula, pharynx and larynx)

• At least one moderate to severe severe angioedema symptom as assessed by the investigator, requiring a medical intervention

• Signed written Informed Consent Form

Exclusion Criteria:

• Diagnosis of angioedema that was not caused by ACEI: e.g. hereditary angioedema (C1-INH deficiency), allergy, anaphylaxis, insect bite, trauma, infection, abscess, tumor, post-radiation or post-operative or processes related to salivary glands and others where it is unlikely that the ACEI is causing the angioedema

• Participation in a clinical trial of another investigational medicinal product (IMP) within 30 days

• Patients with acute urticaria

• Patients with a medical history of any angioedema before taking an ACEI

• Patients with an acute rash or hives in the face or somewhere else

• Unstable angina or acute myocardial infarction

• Acute heart failure

• Serious concomitant illnesses that the physician considers to be a contraindication for participation in the trial

• Pregnancy and/or breast-feeding

• Mental condition rendering the patients, in the opinion of the investigator, unable to understand the nature, scope and possible consequences of the study;

• Unlikely to comply with the protocol, e.g., uncooperative attitude, inability to return for the follow-up visit, or unlikely to complete the study for any reason.