Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06348173
Status:
COMPLETED
Last Update Posted:
2024-04-04
First Post:
2024-03-28
Brief Title:
Response and Remission to Treatment With Anti-IL5IL5R Antagonists
Sponsor:
Université de Montréal
Organization:
Université de Montréal
Study Overview
Official Title:
Response and Remission to Treatment With Anti-IL5IL5R Antagonists 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 aim of this retrospective observational study is to compare the response and remission rate after treatment with IL5IL5-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
This study will be performed using the charts of the patients
Detailed Description:
Objective To compare the response and remission rate after treatment with IL5IL5-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 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 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 IL5IL5R 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
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 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 IL5IL5R 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
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