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NCT Number: NCT06348173

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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital du Sacré-Coeur de Montréal

Montreal, Quebec, H4J 1C5, Canada

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mepolizumab

Drug

Compare the response to mepolizumab and benralizumab before and after treatment

Other names: benralizumab

Primary outcomes

  1. Response to IL5/IL5R antagonists one year after cohort entry among subjects fulfilling and not fulfilling the original RCT inclusion criteria

    Time frame: one year

    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.

  2. Remission rate with IL5/IL5R antagonists one year after cohort entry in subjects fulfilling and not fulfilling the original RCT inclusion criteria

    Time frame: One year

    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.

Sponsors and collaborators

Lead sponsor

Université de Montréal

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 4, 2024
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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