AsthmaNCT04578171
Residual Exacerbations With Mepolizumab
An observational study of Asthma, run by Laval University at 1 site in Canada.
Trial summary
This will be a two-year prospective study to characterize the nature of the remaining asthma exacerbations in patients treated with mepolizumab. Participants will be assessed every six months from pre- until two years of treatment in addition to whenever they experience an exacerbation of asthma during the study… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Asthma
- What is being tested?
- Mepolizumab
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 6 Jul 2021to Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe asthma treated with mepolizumab at the IUCPQ-UL a tertiary care center from the Quebec city area.
Who may be able to join
- With a proven diagnosis of severe asthma as defined by the Canadian Thoracic Society
- Eligible for mepolizumab treatment
- Able and willing to sign the informed consent form
Who cannot join
- Any respiratory disease apart from asthma
- Confounding comorbidities sur as eosinophilic granulomatosis with polyangiitis (EGPA) or hypereosinophilic syndrome
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, G6K 1L8
Andréanne Côté, MD-MSc, 4186564747, andreanne.cote@criucpq.ulaval.ca
Marie-Eve Boulay, 4186568711 ext. Côté, marie-eve.boulay@criucpq.ulaval.ca
About this study
Official title: Type and Mechanisms of Residual Asthma Exacerbations in Patients Treated With Mepolizumab
This will be a two-year prospective study to characterize the nature of the remaining asthma exacerbations in patients treated with mepolizumab. Participants will be assessed every six months from pre- until two years of treatment in addition to whenever they experience an exacerbation of asthma during the study period. During these visits, various clinical, physiological and inflammatory outcomes will be assessed.
Read the detailed description
Before initiation of mepolizumab, a recording of patient's demographics, clinical, physiological and inflammatory features will be recorded. All subjects will be reassessed for the above measures at 6, 12, 18 and 24 months.
In addition to the above visits, patients will be assessed every time they experience either moderate or severe exacerbation of asthma over the treatment period.
Based on the percentage of sputum eosinophils and neutrophils, the type of inflammatory exacerbation will be determined
- Conditions
- Asthma
- Being tested
- Mepolizumab
- Keywords
- exacerbation, inflammation, monoclonal antibody
- Medical subject headings
- Asthma, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MepolizumabDrug
Also called nucala
100 mg subcutaneous injections every four weeks
| Study group | Role | What they receive |
|---|---|---|
| Study population | Subjects with severe asthma treated with mepolizumab Receives: Drug: Mepolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of eosinophilic vs non-eosinophilic remaining exacerbation during the treatment period
Eosinophilic exacerbation defined as >=3% sputum eosinophils. Ratio of eosinophilic vs non eosinophilic asthma exacerbation
Measured: Between baseline and month 24
Secondary outcomes (6)
Change from baseline in asthma control on the Asthma Control Questionnaire (ACQ-5) at 24 months
The ACQ-5 is a validated, self-reported questionnaire assessing asthma control over the last week. Possible scores range from 0 (complete control) to 5 (no control). Change = (Month 24 score - baseline score)
Measured: Baseline and month 24
Change from baseline in post-bronchodilator forced expiratory volume in one second (FEV1) at 24 months
Value of FEV1 measured after inhalation of 400ug of salbutamol. Recorded in Li. (Month 24 FEV1 value - baseline FEV1 value)
Measured: Baseline and month 24
Change from baseline in post-bronchodilator FEV1/forced vital capacity (FVC) ratio at 24 months
Value of FEV1/FVC measured after inhalation of 400 ug of salbutamol. (Month 24 value - baseline value)
Measured: Baseline and month 24
Change from baseline in fraction of exhaled nitric oxide (FeNO) levels at 24 months
Recorded in ppb using the mean of two reproducible measurements. (Month 24 value - baseline value)
Measured: Baseline and month 24
Change from baseline in percentage of sputum eosinophils at 24 months
Determined from induced sputum analysis. (Month 24 sputum eosinophil percentages - baseline sputum eosinophil percentages)
Measured: Baseline and month 24
Change from baseline in percentage of sputum neutrophils
Determined from induced sputum analysis. (Month 24 sputum neutrophil percentages - baseline sputum neutrophil percentages).
Measured: Baseline and month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start6 Jul 2021
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Andréanne Côté, Laval University
- Investigators
- Andréanne Côté, MD, Principal investigator, IUCPQ-UL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578171
- Sponsor's protocol ID
- CÉR21903
- Status last verified
- Feb 2025
- First submitted
- 28 Sep 2020
- Last updated
- 10 Feb 2025
- Results posted
- No
- 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 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Type and Mechanisms of Residual Asthma Exacerbations in Patients Treated With Mepolizumab
- ClinicalTrials.gov ID
- NCT04578171
- Acronym / sponsor ID
- CÉR21903
- Conditions
- Asthma
- Keywords
- exacerbation, inflammation, monoclonal antibody
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a two-year prospective study to characterize the nature of the remaining asthma exacerbations in patients treated with mepolizumab. Participants will be assessed every six months from pre- until two years of treatment in addition to whenever they experience an exacerbation of asthma during the study period. During these visits, various clinical, physiological and inflammatory outcomes will be assessed.
Detailed description
Before initiation of mepolizumab, a recording of patient's demographics, clinical, physiological and inflammatory features will be recorded. All subjects will be reassessed for the above measures at 6, 12, 18 and 24 months.
In addition to the above visits, patients will be assessed every time they experience either moderate or severe exacerbation of asthma over the treatment period.
Based on the percentage of sputum eosinophils and neutrophils, the type of inflammatory exacerbation will be determined
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | – | Drug: MepolizumabSubjects with severe asthma treated with mepolizumab |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe asthma treated with mepolizumab at the IUCPQ-UL a tertiary care center from the Quebec city area.
Key inclusion criteria (3 listed)
- With a proven diagnosis of severe asthma as defined by the Canadian Thoracic Society
- Eligible for mepolizumab treatment
- Able and willing to sign the informed consent form
Key exclusion criteria (2 listed)
- Any respiratory disease apart from asthma
- Confounding comorbidities sur as eosinophilic granulomatosis with polyangiitis (EGPA) or hypereosinophilic syndrome
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 |
|---|---|---|
| MepolizumabAlso: nucala100 mg subcutaneous injections every four weeks | Drug | Study population |
Primary outcome
Proportion of eosinophilic vs non-eosinophilic remaining exacerbation during the treatment period
Time frame: Between baseline and month 24
Eosinophilic exacerbation defined as >=3% sputum eosinophils. Ratio of eosinophilic vs non eosinophilic asthma exacerbation
6 secondary outcomes
Change from baseline in asthma control on the Asthma Control Questionnaire (ACQ-5) at 24 months
Time frame: Baseline and month 24
Change from baseline in post-bronchodilator forced expiratory volume in one second (FEV1) at 24 months
Time frame: Baseline and month 24
Change from baseline in post-bronchodilator FEV1/forced vital capacity (FVC) ratio at 24 months
Time frame: Baseline and month 24
Change from baseline in fraction of exhaled nitric oxide (FeNO) levels at 24 months
Time frame: Baseline and month 24
Change from baseline in percentage of sputum eosinophils at 24 months
Time frame: Baseline and month 24
Change from baseline in percentage of sputum neutrophils
Time frame: Baseline and month 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- 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.
Andréanne Côté, MD principal investigator
IUCPQ-UL
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 Asthma, run by Laval University 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 10 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie-Eve Boulay, MSc (4186568711 ext. 2617, marie-eve.boulay@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of eosinophilic vs non-eosinophilic remaining exacerbation during the treatment period (time frame: Between baseline and month 24). 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 10 Feb 2025.