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AMelioration of Angiotensin Converting Enzyme Inhibitor Induced Angioedema Study

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ClinicalTrials.gov Identifier: NCT01154361
Recruitment Status : Completed
First Posted : June 30, 2010
Last Update Posted : December 23, 2011
Sponsor:
Information provided by:
Technische Universität München

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Angioedema Drug: Icatibant (subcutaneous) and plazebo (intravenous) Drug: Cortisone + Clemastin (intravenous) and plazebo (subcutaneous) Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A Drug: Icatibant (subcutaneous) and plazebo (intravenous)
Active Comparator: Arm B Drug: Cortisone + Clemastin (intravenous) and plazebo (subcutaneous)


Outcome Measures
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Primary Outcome Measures :
  1. Time to complete resolution of angioedema

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01154361


Locations
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Germany
Klinikum rechts der Isar Hals-Nasen-Ohrenklinik der TUM
Munich, Bavaria, Germany, 81675
Sponsors and Collaborators
Technische Universität München
Investigators
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Principal Investigator: Murat Bas, Dr. Klinikum rechts der Isar, Hals-Nasen-Ohrenklinik, Ismaninger Str. 22 81675 München
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT01154361    
Other Study ID Numbers: AMACE
First Posted: June 30, 2010    Key Record Dates
Last Update Posted: December 23, 2011
Last Verified: December 2011
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:
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Angioedema
Vascular Diseases
Cardiovascular Diseases
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cortisone
Icatibant
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Bradykinin B2 Receptor Antagonists
Bradykinin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors