AMelioration of Angiotensin Converting Enzyme Inhibitor Induced Angioedema Study
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Angioedema |
Drug: Icatibant (subcutaneous) and plazebo (intravenous) Drug: Cortisone + Clemastin (intravenous) and plazebo (subcutaneous) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multicenter Study, Randomized, Double-blind With 2 Groups as Prove of Concept for the Treatment of ACEI Induced Angioedema With Subcutaneous Icatibant |
- Time to complete resolution of angioedema
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm A | Drug: Icatibant (subcutaneous) and plazebo (intravenous) |
| Active Comparator: Arm B | Drug: Cortisone + Clemastin (intravenous) and plazebo (subcutaneous) |
Detailed Description:
Sudden occurrence of subcutaneous or submucosal non-itchy swelling, so-called angioedema, is a well known side effect of angiotensin-converting enzyme inhibitors (ACEi), which may become life-threatening if the upper airway is involved. To be note, ACEi induced angioedema were always located in the head and neck region.
The pathophysiology of ACE inhibitor (ACEi) induced angioedema most likely resembles that of hereditary angioedema (HAE), i.e. it is mainly mediated by bradykinin induced activation of vascular bradykinin B2 receptors (BKR-2). In contrast to an increased bradykinin generation in HAE, treatment with ACEi decreases the bradykinin degradation in plasma and increases the biological activity of bradykinin.
The current pharmacotherapy of ACEi induced angioedema is not satisfactory. Antihistamines and corticosteroids may be effective in the treatment of urticaria with cutaneous edema and itchy, but are theoretically ineffective and hence superfluous in bradykinin induced angioedema. However, glucocorticoids still belong to the standard treatment of angioedema.
We hypothesized that the BKR-2 antagonist icatibant might be an effective therapy for ACEi-induced angioedema.
Patients with ACEi induced angioedema, located in the upper aero-digestive tract will be randomized and treated either with icatibant and plazebo or cortisone with clemastin and plazebo.
Eligibility| Ages Eligible for Study: | 18 Years to 84 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01154361
| Germany | |
| Klinikum rechts der Isar Hals-Nasen-Ohrenklinik der TUM | |
| Munich, Bavaria, Germany, 81675 | |
| Principal Investigator: | Murat Bas, Dr. | Klinikum rechts der Isar, Hals-Nasen-Ohrenklinik, Ismaninger Str. 22 81675 München |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT01154361 History of Changes |
| Other Study ID Numbers: | AMACE |
| Study First Received: | June 29, 2010 |
| Last Updated: | December 22, 2011 |
| Health Authority: | Germany: Regierung von Oberbayern |
Keywords provided by Technische Universität München:
|
ACE inhibitor induced angioedema Bradykinin Non-itching edema Non-allergic angioedema Quincke edema |
Drug induced angioedema Bradykinin B2 receptor antagonist Icatibant HOE 140 |
Additional relevant MeSH terms:
|
Angioedema Vascular Diseases Cardiovascular Diseases Urticaria Skin Diseases, Vascular Skin Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Icatibant Cortisone Bradykinin Bradykinin B2 Receptor Antagonists Angiotensin-Converting Enzyme Inhibitors Enzyme Inhibitors |
Anti-Inflammatory Agents Vasodilator Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antirheumatic Agents Bradykinin Receptor Antagonists Molecular Mechanisms of Pharmacological Action Complement Inactivating Agents Immunosuppressive Agents Immunologic Factors Protease Inhibitors |
ClinicalTrials.gov processed this record on September 30, 2016