Clinical Trials Directory

Trials / Completed

CompletedNCT06348173

Response and Remission to Treatment With Anti-IL5/IL5R Antagonists

Response and Remission to Treatment With Anti-IL5/IL5R Antagonists in a Real-world Setting

Status
Completed
Phase
Study type
Observational
Enrollment
109 (actual)
Sponsor
Université de Montréal · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers

Summary

The aim of this retrospective observational study is to compare the response and remission rate after treatment with IL5/IL5-R antagonists in asthmatics who would and would have not met the inclusion criteria of the original randomized clinical trials. This study will be performed using the charts of the patients.

Detailed description

Objective To compare the response and remission rate after treatment with IL5/IL5-R antagonists in asthmatics who would and would have not met the inclusion criteria of the original RCTs. After having obtained authorization from the ethics committee of the CIUSSS du nord de l'île de Montréal and from the director of the Professional Services, all the charts of patients who received anti IL5/IL-5R at the tertiary asthma clinic of the Hôpital du Sacré-Coeur de Montréal will be reviewed. Patients aged 75 years or younger, with a smoking history of less than 10 pack-year, and a FEV1 \<80% predicted with reversibility in the previous year will be considered to fulfill the RCTs criteria. Response to treatment was defined by at least a 50% reduction in asthma exacerbations or in oral corticosteroids (OCS) doses in the year following the initiation of IL5/IL5R antagonists. Clinical remission on treatment at one year was defined as no exacerbation, no OCS and la 10% or less decrease in pre-bronchodilator FEV1 compared with baseline value.

Conditions

Interventions

TypeNameDescription
DRUGMepolizumabCompare the response to mepolizumab and benralizumab before and after treatment

Timeline

Start date
2023-06-01
Primary completion
2023-11-30
Completion
2023-11-30
First posted
2024-04-04
Last updated
2024-04-04

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT06348173. Inclusion in this directory is not an endorsement.