Bradykinin Receptor Blocker in ACE Inhibitor-associated Angioedema

What Was Tested

In this phase 1 trial, researchers set out to test Icatibant.

It had two arms (groups): HOE-140 (experimental) and Placebo (placebo comparator).

Administration of placebo 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

13 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.

The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: pregnant or breastfeeding; started taking birth control pills in the 6 months prior to study entry.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Icatibant and who got the comparison, which limits bias.

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

Neither the participants nor the staff measuring them knew who was on Icatibant, so expectations could not easily colour the readings.

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

It started in 2007-09 with completion listed for 2011-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Time to resolution of angioedema, as defined as the time interval between when the participant first noted the onset of symptoms and when there is no objective evidence of angioedema by physical examination (time frame: Measured at follow-up visit 7 days following resolution of angioedema).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Icatibant in 13 people.

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

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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