AMelioration of Angiotensin Converting Enzyme Inhibitor Induced Angioedema Study

What Was Tested

The trial (phase 2) is built around Icatibant.

This is a multicenter study recruiting patients with angioedema induced by ACEI.

In cases with fast progression of edema after application the study-drug, a second application with icatibant could be necessary.

It had two arms (groups): Arm A (experimental) and Arm B (active comparator).

The registry classes the interventions as drug.

More on the Plan

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).

However, glucocorticoids still belong to the standard treatment of angioedema.

Who Took Part

It was open to people of any sex aged from 18 years up to 84 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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).

The full record lists 7 inclusion and 11 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Because people in this Icatibant study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Icatibant group and the comparison group ran side by side rather than switching.

As a double-blind Icatibant study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Time to complete resolution of angioedema.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Icatibant in people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Icatibant compound page, all human trials.