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Symptoms control and adhErenCe assessment during treatment with mepolizUmab new pREfilled devices. SECURE
EU CTIS ID: 2022-501029-19-00
What this study is testing
Compare compliance and asthma control after 6 months of treatment by Mepolizumab (M+ 1 after the 6th injection) between: A1 - Group of patients receiving Mepolizumab using a pre-filled syringe (PFS) administered monthly by a nurse, using a pre-filled syringe (PFS) B1 - Group of patients receiving self-administered Mepolizumab monthly, using an auto-injector pen (AIP)
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient aged ≥ 18 years
- Severe asthma diagnosed by a pulmonologist and followed for at least a year
- Blood eosinophilia ≥ 0.15 G / L in the 12 months preceding inclusion in the trial.
- At least 2 exacerbations in the past 12 months, each time treated with oral corticosteroid therapy or an increase in dosage of oral corticosteroid therapy prescribed for a long time, for at least 72 hours
- High dose inhaled corticosteroid therapy (> 800 μg / d budesonide,> 500 μg / d fluticasone,> 1000 μg / d beclometasone, etc.) and at least one second controller asthma treatment with LABA or LAMA
- Patient affiliated to a social security scheme
You likely can't join if
- Pregnant woman (urinary beta-HCG positive at inclusion) or breastfeeding
- Patient under guardianship, curatorship or legal protection
- Active smoking or ex-smoking for less than 6 months and more than 10 pack-years
- Exacerbation in the 4 weeks preceding first mepolizumab injection
- Patient who has already been treated with Mepolizumab or another anti-IL-5 or -5R treatment
- Patient currently using a biotherapy indicated in severe asthma other than anti-IL5 or 5R treatments or stopped for less than 2 months
See the full eligibility criteria
- Patient aged ≥ 18 years
- Severe asthma diagnosed by a pulmonologist and followed for at least a year
- Blood eosinophilia ≥ 0.15 G / L in the 12 months preceding inclusion in the trial.
- At least 2 exacerbations in the past 12 months, each time treated with oral corticosteroid therapy or an increase in dosage of oral corticosteroid therapy prescribed for a long time, for at least 72 hours
- High dose inhaled corticosteroid therapy (> 800 μg / d budesonide,> 500 μg / d fluticasone,> 1000 μg / d beclometasone, etc.) and at least one second controller asthma treatment with LABA or LAMA
- Patient affiliated to a social security scheme
- Patient able to give free, informed and written consent.
- Patient must have an efficient contraception method
- Pregnant woman (urinary beta-HCG positive at inclusion) or breastfeeding
- Patient under guardianship, curatorship or legal protection
- Active smoking or ex-smoking for less than 6 months and more than 10 pack-years
- Exacerbation in the 4 weeks preceding first mepolizumab injection
- Patient who has already been treated with Mepolizumab or another anti-IL-5 or -5R treatment
- Patient currently using a biotherapy indicated in severe asthma other than anti-IL5 or 5R treatments or stopped for less than 2 months
- Treatment underway with another biotherapy not indicated for severe asthma
- Patient participating in other interventional research, excluding routine care research (old regulation) and category 2 research not interfering with primary endpoint analysis
- Other chronic respiratory pathology (bronchiectasis, COPD, pulmonary fibrosis, etc.)
- Any other uncontrolled chronic pathology, the presence of which would be considered incompatible with the performance of the study by the investigator
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.