Angioedema Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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