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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06348173
• Other study ID #: 2021-2190
• Status: Completed
• Start date: June 1, 2023
• Est. completion date: November 30, 2023

Study information

• Verified date: January 2024
• Source: Université de Montréal
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Mepolizumab
Compare the response to mepolizumab and benralizumab before and after treatment

Locations

Country	Name	City	State
Canada	Hôpital du Sacré-Coeur de Montréal	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Université de Montréal	GlaxoSmithKline

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to IL5/IL5R antagonists one year after cohort entry among subjects fulfilling and not fulfilling the original RCT inclusion criteria	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.	one year
Primary	Remission rate with IL5/IL5R antagonists one year after cohort entry in subjects fulfilling and not fulfilling the original RCT inclusion criteria	Clinical remission on treatment at one year post cohort entry was defined as no asthma exacerbation, no treatment with OCS and a 10% or less decrease in pre-bronchodilator FEV1 compared with baseline value.	One year