Severe Asthma Clinical Trial
Official title:
Assessment and Prediction of the Effectiveness of Mepolizumab Anti-IL-5/IL5R Inhibitors in a Real-world Setting
Verified date | January 2024 |
Source | Hopital du Sacre-Coeur de Montreal |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The goal of this observational study is to assess the response to treatment, in patients 18 years and older diagnosed with severe asthma in whom an IL5/IL5R antagonists was initiated between 2012 and 2020. The main question[s] it aims to answer are: - What is the response rate after one year of treatment with IL5/IL5R antagonists. - What is the response and remission rate after one year of treatment with IL5/IL5R antagonists in subjects who fullfilled the original randomized control trials (RCTs) inclusion criteria compared with those who did not.
Status | Completed |
Enrollment | 109 |
Est. completion date | November 29, 2023 |
Est. primary completion date | June 13, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: All patients 18 years and older diagnosed with severe asthma in whom an IL5/IL5R antagonist was initiated at the outpatient asthma clinic of a tertiary center (Sacre-Coeur Hospital) in Montreal.c between 2012 and 2020. Exclusion Criteria: None |
Country | Name | City | State |
---|---|---|---|
Canada | Hôpital du Sacré-Coeur de Montréal | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Hopital du Sacre-Coeur de Montreal | GlaxoSmithKline |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response to IL5/IL5R antagonist | 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 antagonist | Clinical remission on treatment at one year was defined as no asthma exacerbation, no treatment with oral corticosteroid and a less than 10% decrease in pre-bronchodilator FEV1 compared with baseline value. | one year | |
Secondary | Response to IL5/IL5R antagonists one year after CE among subjects who did and did not fullfill the inclusion criteria of the original randomized control trials. | 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 | |
Secondary | Clinical remission of asthma after treatment with IL5/IL5R antagonists among subjects who did and did not fullfill the inclusion criteria of the original randomized control trials. | Clinical remission on treatment at one year was defined as no asthma exacerbation, no treatment with oral corticosteroid and a less than 10% decrease in pre-bronchodilator FEV1 compared with baseline value. | one year |
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