The study objective is to assess the efficacy and safety of the Bradykinin-2 (BK-2) receptor antagonist Icatibant compared to a historic group of 47 patients with ACE inhibitor induced angioedema which we have been previously treated in our centers with current “standard” therapy (250 mg methylprednisolon and 2 mg clemastine).
Conditions
Interventions
Trade Name: Solu-Decortin
Product Name: Prednisolon
Pharmaceutical Form: Solution for injection
INN or Proposed INN: prednisolon
Concentration unit: mg milligram(s)
Concentration type: equal
Concentra
Sponsors
Medizinische Fakultaet der Technischen Universitaet Muenchen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age ³ 18 years=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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, local 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. akte heart disease NYHA-Clssification 3-4
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study objective is to assess the efficacy and safety of the Bradykinin-2 (BK-2) receptor antagonist Icatibant compared to a historic group of 47 patients with ACE inhibitor induced angioedema which we have been previously treated in our centers with current “standard” therapy (250 mg methylprednisolon and 2 mg clemastine). ;Secondary Objective: Secondary Endpoints Secondary efficacy endpoints: • The rate of response at 4 hours( Symptom Score: 7-point score) • Time to onset of symptom relief • Need for rescue medication, airway management • Time to resolution of each symptom by patient and physician • Durability of treatment effect • Regression of symptoms according to patient (first improvement) • VAS at 4 hours compared to VAS immediately before injection Safety and tolerability endpoints: • Number and proportion of AEs • Vital signs • Safety lab – Routine lab ;Primary end point(s): • Time to complete symptom relief Pre-treatment symptoms evaluated/judged as severe must be assessed as mild or absent following treatment. Pre-treatment symptoms evaluated/judged as moderate must be assessed as absent following treatment. Symptom relief must be confirmed by three consecutive measurements. The time point of the first documented measurement will be taken as time to angioedema attack resolution. | — |
Countries
Germany
Outcome results
None listed