Randomized placebo-controlled trial of the bradykinin B₂ receptor antagonist icatibant for the treatment of acute attacks of hereditary angioedema: the FAST-3 trial

What Was Tested

Researchers studied Bradykinin and Icatibant in this randomized controlled trial publication.

The For Angioedema Subcutaneous Treatment (FAST)-3 study was a phase III, randomized, double-blind, placebo-controlled study of icatibant (bradykinin B(2) receptor antagonist) in subjects with hereditary angioedema (HAE) resulting from C1-INH deficiency or dysfunction (type I/II).

Who Took Part

According to the abstract, 5 subjects were involved.

By PubMed's age tags, the people studied were adults, both men and women.

Subjects with moderate to very severe cutaneous or abdominal symptoms received icatibant (n = 43) or placebo (n = 45).

Five subjects with laryngeal (mild-to-moderate) first attacks received icatibant (n = 3) or placebo (n = 2), and 5 subjects with severe laryngeal first attacks received open-label icatibant.

How the Study Was Run

The design is described as randomized, double-blind, open-label and placebo-controlled.

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

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

Being open-label, the Bradykinin study did not mask who received what.

The comparison arm used a placebo, so changes seen with Bradykinin could be set against what happens without it.

What Was Measured

PubMed files the paper under topics including Angioedemas, Hereditary, Anti-Inflammatory Agents, Non-Steroidal, Bradykinin, Bradykinin B2 Receptor Antagonists and Kaplan-Meier Estimate.

What This Means in Plain Language

The paper is a randomized, double-blind and open-label study of Bradykinin and Icatibant in 5 subjects.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

The abstract goes on to report its results in about 6 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2011 (Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology), a journal based in United States.

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