Severe AsthmaNCT06239441
Effectiveness of Anti-IL-5/IL5R Inhibitors
An observational study of Severe Asthma, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
Trial 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 IL5/IL5R antagonists was initiated between 2012 and 2020. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Asthma
- What is being tested?
- IL5/IL5R Antagonists
- How many people
- 108 participants
- Where
- 1 siteCanada
- Study dates
- 16 Feb 2021to 29 Nov 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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).
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment and Prediction of the Effectiveness of Mepolizumab Anti-IL-5/IL5R Inhibitors in a Real-world Setting
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.
Read the detailed description
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:
- 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.
- To compare the response and remission rate after one year of treatment with IL5/IL5-R antagonists in asthmatics who would and would have not met the inclusion criteria of the original randomized clinical trials.
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.
- Conditions
- Severe Asthma
- Being tested
- IL5/IL5R Antagonists
- Keywords
- Severe Asthma, IL5 antagonist
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IL5/IL5R AntagonistsDrug
Also called mepolizumab, benralizumab
Treatment with IL5/IL5R antagonists for one year
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start16 Feb 2021
- Primary completion13 Jun 2023
- Study completion29 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Severe AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Catherine Lemiere, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Investigators
- Catherine Lemiere, MD, Principal investigator, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06239441
- Sponsor's protocol ID
- 2021-2190
- Status last verified
- Oct 2024
- First submitted
- 25 Jan 2024
- Last updated
- 28 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment and Prediction of the Effectiveness of Mepolizumab Anti-IL-5/IL5R Inhibitors in a Real-world Setting
- ClinicalTrials.gov ID
- NCT06239441
- Acronym / sponsor ID
- 2021-2190
- Conditions
- Severe Asthma
- Keywords
- Severe Asthma, IL5 antagonist
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de MontrealUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 13 Jun 2023 (actual)
- Study completion
- 29 Nov 2023 (actual)
- First posted
- 2 Feb 2024 (actual)
- Results
- Posted 28 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- 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.
- To compare the response and remission rate after one year of treatment with IL5/IL5-R antagonists in asthmatics who would and would have not met the inclusion criteria of the original randomized clinical trials.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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).
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IL5/IL5R AntagonistsAlso: mepolizumab, benralizumabTreatment with IL5/IL5R antagonists for one year | Drug | – |
Primary outcome
Response to IL5/IL5R Antagonist
Time frame: one year
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.
Remission Rate With IL5/IL5R Antagonist
Time frame: one year
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Lemiere, MD principal investigator
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Asthma, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to IL5/IL5R Antagonist (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.