NCT06239441

Effectiveness of Anti-IL-5/IL5R Inhibitors

Completed Results posted Last updated 28 October 2024

What this trial tests

trial testing IL5/IL5R Antagonists in Severe Asthma in 108 participants. Completed in 29 November 2023.

Timeline

16 February 2021

Primary endpoint
13 June 2023

29 November 2023

Quick facts

Lead sponsor	Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Status	Completed
Study type	OBSERVATIONAL
Enrollment	108
Start date	16 February 2021
Primary completion	13 June 2023
Estimated completion	29 November 2023
Sites	1 location across Canada

Drugs / interventions tested

• IL5/IL5R Antagonists — full drug profile →

Conditions studied

• Severe Asthma — all drugs for Severe Asthma →

Sponsor

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal — full company profile →

Who can join

18 and older, any sex, with Severe Asthma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Response to IL5/IL5R Antagonist Primary · one year

Percentage of subjects achieving response to IL5/IL5R antagonists. A response to treatment was defined as a reduction of asthma exacerbations of at least 50% or a 50% or higher reduction of the OCS doses for steroid dependant patients in the year following the initiation of an IL5/IL5R antagonist compared to the year preceding the initiation of the treatment.

Group	Value	95% CI
Randomized Clinical Trial (RCT) In Group	76.5	54 – 99
Randomized Clinical Trial (RCT) Out Group	82.5	74 – 91

Remission Rate With IL5/IL5R Antagonist Primary · one year

Percentage of subjects achieving asthma remission. Clinical remission on treatment at one year was defined as no asthma exacerbation, no treatment with oral corticosteroid and a less than 10% decrease in pre-bronchodilator FEV1 compared with baseline value.

Group	Value	95% CI
RCT In	45	21.1 – 68.9
RCT Out	24.4	14.6 – 34.1

Sponsor's own description

The goal of this observational study is to assess the response to treatment, in patients 18 years and older diagnosed with severe asthma in whom an IL5/IL5R antagonists was initiated between 2012 and 2020.

The main question\[s\] it aims to answer are:

* What is the response rate after one year of treatment with IL5/IL5R antagonists.
* What is the response and remission rate after one year of treatment with IL5/IL5R antagonists in subjects who fullfilled the original randomized control trials (RCTs) inclusion criteria compared with those who did not.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Response to IL-5/IL-5R Antagonists and Remission Rate in Patients With Severe Asthma Who Would Have Been Excluded From the Pivotal Clinical Trials.
   Blouin C, Forget A, Blais L, Lemiere C. · · 2025 · PMID 40154738 · DOI 10.1016/j.jaip.2025.03.025