Understanding asthma flare-ups in patients treated with mepolizumab
Type and Mechanisms of Residual Asthma Exacerbations in Patients Treated With Mepolizumab
This study looks at how asthma flare-ups happen in people taking mepolizumab over two years to better understand their symptoms and inflammation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Laval University Academic / other |
| Drugs / interventions | mepolizumab |
| Locations | 1 site (Québec, Quebec) |
| Trial ID | NCT04578171 on ClinicalTrials.gov |
What this trial studies
This observational study aims to characterize the nature of asthma exacerbations in patients receiving mepolizumab over a two-year period. Participants will undergo assessments every six months, as well as during any asthma exacerbations, to evaluate clinical, physiological, and inflammatory outcomes. The study will record patient demographics and various health measures before treatment and at specified intervals throughout the study. The focus will be on determining the type of inflammatory exacerbation based on sputum eosinophils and neutrophils.
Who should consider this trial
Good fit: Ideal candidates are individuals with a confirmed diagnosis of severe asthma who are eligible for mepolizumab treatment.
Not a fit: Patients with other respiratory diseases or specific comorbidities like eosinophilic granulomatosis with polyangiitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness of mepolizumab in managing asthma exacerbations, potentially leading to improved treatment strategies.
How similar studies have performed: While the approach of assessing asthma exacerbations in treated patients is not novel, the specific focus on mepolizumab's impact on these exacerbations adds valuable data to existing literature.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Any respiratory disease apart from asthma * Confounding comorbidities sur as eosinophilic granulomatosis with polyangiitis (EGPA) or hypereosinophilic syndrome
Where this trial is running
Québec, Quebec
- Institut universitaire de cardiologie et de pneumologie de Québec — Québec, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Andréanne Côté, MD — Iucpq-Ul
- Study coordinator: Marie-Eve Boulay, MSc
- Email: marie-eve.boulay@criucpq.ulaval.ca
- Phone: 4186568711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.