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

NCT ID: NCT06348173

Last Updated: 2024-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

109 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-01

Study Completion Date

2023-11-30

Brief Summary

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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

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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

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Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Mepolizumab

Compare the response to mepolizumab and benralizumab before and after treatment

Intervention Type DRUG

Other Intervention Names

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benralizumab

Eligibility Criteria

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Inclusion Criteria

Patients 18 years and older who were followed at the outpatient asthma clinic of Sacre-Cœur Hospital and have been treated with anti-IL5/il5R between 2016 and 2020.

Exclusion Criteria

None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Université de Montréal

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Catherine Lemiere, MD

Role: PRINCIPAL_INVESTIGATOR

Université de Montréal

Locations

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Hôpital du Sacré-Coeur de Montréal

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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2021-2190

Identifier Type: -

Identifier Source: org_study_id

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