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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepolizumab | Drug | Compare the response to mepolizumab and benralizumab before and after treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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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
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Lemiere, MD | Université de Montréal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital du Sacré-Coeur de Montréal | Montreal | Quebec | H4J 1C5 | Canada |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C434107 | mepolizumab |
| C571386 | benralizumab |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |