Ignite Creation Date:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2025-12-26 @ 10:04 PM
Study NCT ID:
NCT01154361
Status:
COMPLETED
Last Update Posted:
2011-12-23
First Post:
2010-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AMelioration of Angiotensin Converting Enzyme Inhibitor Induced Angioedema Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000799', 'term': 'Angioedema'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014581', 'term': 'Urticaria'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C065679', 'term': 'icatibant'}, {'id': 'D007279', 'term': 'Injections, Subcutaneous'}, {'id': 'D003348', 'term': 'Cortisone'}], 'ancestors': [{'id': 'D007267', 'term': 'Injections'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D015065', 'term': '17-Hydroxycorticosteroids'}, {'id': 'D006889', 'term': 'Hydroxycorticosteroids'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'lastUpdateSubmitDate': '2011-12-22', 'studyFirstSubmitDate': '2010-06-29', 'studyFirstSubmitQcDate': '2010-06-29', 'lastUpdatePostDateStruct': {'date': '2011-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to complete resolution of angioedema'}]}, 'conditionsModule': {'keywords': ['ACE inhibitor induced angioedema', 'Bradykinin', 'Non-itching edema', 'Non-allergic angioedema', 'Quincke edema', 'Drug induced angioedema', 'Bradykinin B2 receptor antagonist', 'Icatibant', 'HOE 140'], 'conditions': ['Angioedema']}, 'referencesModule': {'references': [{'pmid': '25629740', 'type': 'DERIVED', 'citation': 'Bas M, Greve J, Stelter K, Havel M, Strassen U, Rotter N, Veit J, Schossow B, Hapfelmeier A, Kehl V, Kojda G, Hoffmann TK. A randomized trial of icatibant in ACE-inhibitor-induced angioedema. N Engl J Med. 2015 Jan 29;372(5):418-25. doi: 10.1056/NEJMoa1312524.'}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter study recruiting patients with angioedema induced by ACEI.\n\nOpen-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).\n\nIn cases with fast progression of edema after application the study-drug, a second application with icatibant could be necessary. Rescue medication and intervention.', 'detailedDescription': '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.\n\nThe 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.\n\nThe 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.\n\nWe hypothesized that the BKR-2 antagonist icatibant might be an effective therapy for ACEi-induced angioedema.\n\nPatients 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '84 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>= 18 \\<85 years\n* Patient is currently treated with an ACEI\n* Patient must have acute angioedema attack caused by an ACEI\n* Treatment should be administrated within 10 hrs after onset by an ACEI\n* Patient with angioedema of head and /or neck (face, lips, cheeks, tongue, soft palate/uvula, pharynx and larynx)\n* At least one moderate to severe severe angioedema symptom as assessed by the investigator, requiring a medical intervention\n* Signed written Informed Consent Form\n\nExclusion Criteria:\n\n* 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\n* Participation in a clinical trial of another investigational medicinal product (IMP) within 30 days\n* Patients with acute urticaria\n* Patients with a medical history of any angioedema before taking an ACEI\n* Patients with an acute rash or hives in the face or somewhere else\n* Unstable angina or acute myocardial infarction\n* Acute heart failure\n* Serious concomitant illnesses that the physician considers to be a contraindication for participation in the trial\n* Pregnancy and/or breast-feeding\n* Mental condition rendering the patients, in the opinion of the investigator, unable to understand the nature, scope and possible consequences of the study;\n* 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.'}, 'identificationModule': {'nctId': 'NCT01154361', 'briefTitle': 'AMelioration of Angiotensin Converting Enzyme Inhibitor Induced Angioedema Study', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'A Multicenter Study, Randomized, Double-blind With 2 Groups as Prove of Concept for the Treatment of ACEI Induced Angioedema With Subcutaneous Icatibant', 'orgStudyIdInfo': {'id': 'AMACE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'interventionNames': ['Drug: Icatibant (subcutaneous) and plazebo (intravenous)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm B', 'interventionNames': ['Drug: Cortisone + Clemastin (intravenous) and plazebo (subcutaneous)']}], 'interventions': [{'name': 'Icatibant (subcutaneous) and plazebo (intravenous)', 'type': 'DRUG', 'armGroupLabels': ['Arm A']}, {'name': 'Cortisone + Clemastin (intravenous) and plazebo (subcutaneous)', 'type': 'DRUG', 'armGroupLabels': ['Arm B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81675', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Klinikum rechts der Isar Hals-Nasen-Ohrenklinik der TUM', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Murat Bas, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinikum rechts der Isar, Hals-Nasen-Ohrenklinik, Ismaninger Str. 22 81675 München'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}}}}