Effect of Bradykinin Receptor Antagonism on ACE Inhibitor-associated Angioedema

What Was Tested

This registered phase 4 trial tested Icatibant.

It had two arms (groups): icatibant (experimental) and Placebo (placebo comparator).

Subcutaneous at time 0 and 6 hours.

The registry classes the interventions as drug and other.

More on the Plan

People who take ACE inhibitors may develop angioedema, a condition that causes itchy and painful swelling beneath the skin around the eyes, lips, tongue, throat, hands, or feet.

In severe cases, the throat may swell, obstructing the airway and leading to breathing difficulty.

This study will enroll people admitted to the emergency room or hospital who have a severe case of ACE inhibitor-associated angioedema.

Participants will be randomly assigned to receive an injection of either HOE-140 or placebo.

Who Took Part

The registry lists 33 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: The subject has ongoing angioedema while taking an ACE inhibitor. The subject is between 18 and 80 years of age.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: the subject has had angioedema while not taking an ace inhibitor; the subject's angioedema only involves the bowel; the subject is known to be pregnant or has a positive urine pregnancy test.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Icatibant.

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

It started in 2011-08 with completion listed for 2015-09.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Time to Resolution of Angioedema (time frame: 48 hours).

It also tracked 6 secondary outcomes, for example Number of Participants With Admission to Intensive Care Unit, Number of Participants With Requirement for Intubation, Number of Participants Given Steroids, Number of Participants Given Histamine Receptor Type 1 (H1) and Type 2 (H2) Blockers, Number of Participants Given Epinephrine and Systolic Blood Pressure.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Icatibant in 33 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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