Trials / Completed
CompletedNCT06348173
Response and Remission to Treatment With Anti-IL5/IL5R Antagonists
Response and Remission to Treatment With Anti-IL5/IL5R Antagonists in a Real-world Setting
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 109 (actual)
- Sponsor
- Université de Montréal · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Mepolizumab | Compare the response to mepolizumab and benralizumab before and after treatment |
Timeline
- Start date
- 2023-06-01
- Primary completion
- 2023-11-30
- Completion
- 2023-11-30
- First posted
- 2024-04-04
- Last updated
- 2024-04-04
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT06348173. Inclusion in this directory is not an endorsement.