An observational study in Severe Asthma, sponsored by Hopital du Sacre-Coeur de Montreal. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-28.
Sponsored by Hopital du Sacre-Coeur de Montreal · 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:
IL5/IL5-receptor (IL5R) antagonists are effective in reducing asthma exacerbations and have a corticosteroid sparing effect in selected severe eosinophilic asthmatics. The original randomized clinical trials that assessed the efficacy of IL5/IL5-R antagonists included highly selected patients who are not necessarily representative of the asthmatic population treated with IL5/IL5R antagonists in clinical practice.
The aims of this study are:
We will perform a retrospective cohort study using data from the hospital charts of severe asthmatics treated with mepolizumab, reslizumab or benralizumab between November 2012 and December 2020 at the outpatient asthma clinic of a tertiary center (Sacre-Coeur Hospital) in Montreal. Cohort entry (CE) will be defined as the first prescription filled of IL5/IL5R antagonists. Authorization from the research ethics committee of the CIUSSS du Nord-de-l'île-de-Montréal and from the director of Professional Services was obtained.
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 Student's 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 0.05.
Logistic regression analyses will be performed to identify factors associated with a positive response to treatment as well as the achievement of remission on treatment.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 108 is below the median of 150 across 970 observational studies indexed under Asthma.
Browse Asthma studies →Hopital du Sacre-Coeur de Montreal is the lead sponsor of 21 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients 18 years and older diagnosed with severe asthma in whom an IL5/IL5R antagonist was initiated between 2012 and 2020 for were included. Data recorded in the year preceding the initiation of IL5/IL5R 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).
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
Treatment with IL5/IL5R antagonists for one year
Also known as: mepolizumab, benralizumab
Response to IL5/IL5R Antagonist
Percentage of subjects achieving response to IL5/IL5R antagonists. 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.
Time frame: one year
Remission Rate With IL5/IL5R Antagonist
Percentage of subjects achieving asthma remission. 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.
Time frame: one year
| Milestone | RCT in Group | RCT Out Group |
|---|---|---|
| Started | 22 | 86 |
| Completed | 22 | 86 |
| Not completed | 0 | 0 |
Percentage of subjects achieving response to IL5/IL5R antagonists. 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.
| Percent | Randomized Clinical Trial (RCT) In Group | Randomized Clinical Trial (RCT) Out Group |
|---|---|---|
| Response to IL5/IL5R Antagonist | 76.5 (54 to 99) | 82.5 (74 to 91) |
Percentage of subjects achieving asthma remission. 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.
| Percent | RCT In | RCT Out |
|---|---|---|
| Remission Rate With IL5/IL5R Antagonist | 45 (21.1 to 68.9) | 24.4 (14.6 to 34.1) |
Collected over Adverse event were not collected. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| RCT in Group | — | — | — |
| RCT Out Group | — | — | — |
| Age, Continuous(years) | Randomized Clinical Trial (RCT) in Group | Randomized Clinical Trial (RCT) Out Group | Total |
|---|---|---|---|
| Mean | 54.7 ± 12.5 | 59.6 ± 13.6 | 58.7 ± 13.4 |
| Sex: Female, Male(Participants) | Randomized Clinical Trial (RCT) in Group | Randomized Clinical Trial (RCT) Out Group | Total |
|---|---|---|---|
| Female | 13 | 51 | 64 |
| Male | 9 | 35 | 44 |
| Race and Ethnicity Not Collected(Participants) | Randomized Clinical Trial (RCT) in Group | Randomized Clinical Trial (RCT) Out Group | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Randomized Clinical Trial (RCT) in Group | Randomized Clinical Trial (RCT) Out Group | Total |
|---|---|---|---|
| Canada | 22 | 86 | 108 |
| Forced expiratory volume in one second (FEV1) pre bronchodilator (BD)(Litres) | Randomized Clinical Trial (RCT) in Group | Randomized Clinical Trial (RCT) Out Group | Total |
|---|---|---|---|
| Mean | 1.63 ± 0.54 | 1.81 ± 0.86 | 1.73 ± 0.76 |
| Asthma duration(years) | Randomized Clinical Trial (RCT) in Group | Randomized Clinical Trial (RCT) Out Group | Total |
|---|---|---|---|
| Mean | 25.6 ± 16.6 | 22.9 ± 18.9 | 23.8 ± 18.5 |
| Atopy(participants) | Randomized Clinical Trial (RCT) in Group | Randomized Clinical Trial (RCT) Out Group | Total |
|---|---|---|---|
| Number | 19 | 55 | 74 |
| Daily dose of inhaled corticosteroid(microgram) | Randomized Clinical Trial (RCT) in Group | Randomized Clinical Trial (RCT) Out Group | Total |
|---|---|---|---|
| Mean | 1590 ± 419 | 1477 ± 576 | 1505 ± 548 |
1 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Hopital du Sacre-Coeur de Montreal