Asthma
Conditions
Brief 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.
Interventions
DRUGMepolizumab
Compare the response to mepolizumab and benralizumab before and after treatment
Sponsors
GlaxoSmithKline
Université de Montréal
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response to IL5/IL5R antagonists one year after cohort entry among subjects fulfilling and not fulfilling the original RCT inclusion criteria | 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. |
| Remission rate with IL5/IL5R antagonists one year after cohort entry in subjects fulfilling and not fulfilling the original RCT inclusion criteria | 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. |
Countries
Canada
Outcome results
None listed