NCT01154361

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 30, 2010

Completed
Last Updated

December 23, 2011

Status Verified

December 1, 2011

First QC Date

June 29, 2010

Last Update Submit

December 22, 2011

Conditions

Angioedema

Keywords

ACE inhibitor induced angioedemaBradykininNon-itching edemaNon-allergic angioedemaQuincke edemaDrug induced angioedemaBradykinin B2 receptor antagonistIcatibantHOE 140

Outcome Measures

Primary Outcomes (1)

  • Time to complete resolution of angioedema

Study Arms (2)

Arm A

EXPERIMENTAL
Drug: Icatibant (subcutaneous) and plazebo (intravenous)

Arm B

ACTIVE COMPARATOR
Drug: Cortisone + Clemastin (intravenous) and plazebo (subcutaneous)

Interventions

Icatibant (subcutaneous) and plazebo (intravenous)DRUG
Arm A
Cortisone + Clemastin (intravenous) and plazebo (subcutaneous)DRUG
Arm B

Eligibility Criteria

Age18 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum rechts der Isar Hals-Nasen-Ohrenklinik der TUM

Munich, Bavaria, 81675, Germany

Location

Related Publications (1)

  • 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.

    PMID: 25629740DERIVED

MeSH Terms

Conditions

Angioedema

Interventions

icatibantInjections, SubcutaneousCortisone

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesUrticariaSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

InjectionsDrug Administration RoutesDrug TherapyTherapeuticsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds17-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Murat Bas, Dr.

    Klinikum rechts der Isar, Hals-Nasen-Ohrenklinik, Ismaninger Str. 22 81675 München

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 29, 2010

First Posted

June 30, 2010

Last Updated

December 23, 2011

Record last verified: 2011-12

Locations

DE(1)