Ignite Creation Date:
2024-05-05 @ 10:38 PM
Last Modification Date:
2024-10-26 @ 10:22 AM
Study NCT ID:
NCT01154361
Status:
COMPLETED
Last Update Posted:
2011-12-23
First Post:
2010-06-29
Brief Title:
AMelioration of Angiotensin Converting Enzyme Inhibitor Induced Angioedema Study
Sponsor:
Technical University of Munich
Organization:
Technical University of Munich
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2011-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 ie 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
The pathophysiology of ACE inhibitor ACEi induced angioedema most likely resembles that of hereditary angioedema HAE ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None