Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06239441
Status:
COMPLETED
Last Update Posted:
2024-02-02
First Post:
2024-01-25
Brief Title:
Effectiveness of Anti-IL-5IL5R Inhibitors
Sponsor:
Hopital du Sacre-Coeur de Montreal
Organization:
Hopital du Sacre-Coeur de Montreal
Study Overview
Official Title:
Assessment and Prediction of the Effectiveness of Mepolizumab Anti-IL-5IL5R Inhibitors in a Real-world Setting
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 IL5IL5R antagonists was initiated between 2012 and 2020
The main questions it aims to answer are
What is the response rate after one year of treatment with IL5IL5R antagonists
What is the response and remission rate after one year of treatment with IL5IL5R antagonists in subjects who fullfilled the original randomized control trials RCTs inclusion criteria compared with those who did not
The main questions it aims to answer are
What is the response rate after one year of treatment with IL5IL5R antagonists
What is the response and remission rate after one year of treatment with IL5IL5R antagonists in subjects who fullfilled the original randomized control trials RCTs inclusion criteria compared with those who did not
Detailed Description:
Objectives 1 To assess the response to treatment in patients 18 years and older diagnosed with severe asthma in whom an IL5IL5R antagonists was initiated between 2012 and 2020
2 To compare the response and remission rate after one year of treatment with IL5IL5-R antagonists in asthmatics who would and would have not met the inclusion criteria of the original randomized clinical trials
After having obtained authorization from the ethics committee of the CIUSSS du nord de lîle de Montréal and from the director of the Professional Services all the charts of patients who received anti IL5IL-5R at the tertiary asthma clinic of the Hôpital du Sacré-Coeur de Montréal between 2012 and 2020 were reviewed
Population Patients 18 years and older diagnosed with severe asthma in whom an IL5IL5R antagonist was initiated between 2012 and 2020 for the first time were included If a patient had been treated with more than one IL5IL5R antagonist during the study period only the first biologic agent received was considered Data recorded in the year preceding the initiation of IL5IL5R antagonist were compared with data recorded in the year following the initiation of the biological therapy
Subjects who were aged 75 years or younger had a smoking history of less than 10 pack-year a FEV1 of less than 80 of the predicted value along with FEV1 reversibility of at least 12 and 200 ml in the previous year were considered as fulfilling the inclusion criteria of the original RCTs RCT in group Subjects who did not meet one of those criteria were considered as not fulfilling the original RCT inclusion criteria RCT out group
Primary outcomes were the response to IL5IL5R antagonists as well as the remission rate one year after CE in the whole population as well as among RCT in group and RCT out group
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 IL5IL5R antagonist compared to the year preceding the initiation of the treatment
Asthma exacerbations were defined as short treatment of systemic corticosteroids less than 14 days a visit to the emergency department or an hospitalization related to asthma
Clinical remission on treatment at one year post cohort entry was defined as no asthma exacerbation no treatment with OCS and a less than 10 decrease in pre-bronchodilator FEV1 compared with baseline value
Statistical analysis Descriptive statistics will be used to summarize clinical functional and demographic characteristics of the patients of the whole cohort as well as of the RCT in group and RCT out group Baseline data will be recorded on the date closest to cohort entry Results will be expressed as mean and standard deviation except for data with a non-normal distribution which were expressed as median and interquartile ranges and proportions for categorical variables Chi-squared test and Students t test will be used to compare patients characteristics between RCT in group and RCT out group All tests will be two-tailed and the statistical significance level will be set at 005
Logistic regression analyses will performed to identify factors associated with a positive response to treatment as well as the achievement of remission on treatment
2 To compare the response and remission rate after one year of treatment with IL5IL5-R antagonists in asthmatics who would and would have not met the inclusion criteria of the original randomized clinical trials
After having obtained authorization from the ethics committee of the CIUSSS du nord de lîle de Montréal and from the director of the Professional Services all the charts of patients who received anti IL5IL-5R at the tertiary asthma clinic of the Hôpital du Sacré-Coeur de Montréal between 2012 and 2020 were reviewed
Population Patients 18 years and older diagnosed with severe asthma in whom an IL5IL5R antagonist was initiated between 2012 and 2020 for the first time were included If a patient had been treated with more than one IL5IL5R antagonist during the study period only the first biologic agent received was considered Data recorded in the year preceding the initiation of IL5IL5R antagonist were compared with data recorded in the year following the initiation of the biological therapy
Subjects who were aged 75 years or younger had a smoking history of less than 10 pack-year a FEV1 of less than 80 of the predicted value along with FEV1 reversibility of at least 12 and 200 ml in the previous year were considered as fulfilling the inclusion criteria of the original RCTs RCT in group Subjects who did not meet one of those criteria were considered as not fulfilling the original RCT inclusion criteria RCT out group
Primary outcomes were the response to IL5IL5R antagonists as well as the remission rate one year after CE in the whole population as well as among RCT in group and RCT out group
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 IL5IL5R antagonist compared to the year preceding the initiation of the treatment
Asthma exacerbations were defined as short treatment of systemic corticosteroids less than 14 days a visit to the emergency department or an hospitalization related to asthma
Clinical remission on treatment at one year post cohort entry was defined as no asthma exacerbation no treatment with OCS and a less than 10 decrease in pre-bronchodilator FEV1 compared with baseline value
Statistical analysis Descriptive statistics will be used to summarize clinical functional and demographic characteristics of the patients of the whole cohort as well as of the RCT in group and RCT out group Baseline data will be recorded on the date closest to cohort entry Results will be expressed as mean and standard deviation except for data with a non-normal distribution which were expressed as median and interquartile ranges and proportions for categorical variables Chi-squared test and Students t test will be used to compare patients characteristics between RCT in group and RCT out group All tests will be two-tailed and the statistical significance level will be set at 005
Logistic regression analyses will performed to identify factors associated with a positive response to treatment as well as the achievement of remission on treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None