Actively Recruiting
Type and Mechanisms of Residual Asthma Exacerbations in Patients Treated With Mepolizumab
Led by Laval University · Updated on 2025-02-10
60
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
L
Laval University
Lead Sponsor
G
GlaxoSmithKline
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the types and causes of asthma flare-ups that still occur in patients treated with mepolizumab, a medication for severe asthma. This observational study will follow patients over two years to understand the nature of remaining asthma exacerbations and how they relate to inflammation. The study is sponsored by Laval University and focuses on severe asthma patients eligible for mepolizumab treatment. Participants will receive 100 mg of mepolizumab as a subcutaneous injection every four weeks. They will be assessed before starting treatment and then every six months for two years. Additional assessments will take place whenever they experience moderate or severe asthma exacerbations during the study. Researchers will analyze sputum samples to determine the type of inflammation involved in these flare-ups. During study visits, patients will have clinical, physiological, and inflammatory evaluations, including lung function tests and inflammation markers. Outcome measures include the proportion of eosinophilic versus non-eosinophilic exacerbations, changes in asthma control questionnaire scores, lung function measures, and levels of inflammatory cells in sputum over 24 months. The study will closely monitor participants throughout the two-year period to better characterize residual asthma flare-ups under mepolizumab treatment.
CONDITIONS
Brief Title
Residual Exacerbations With Mepolizumab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Any respiratory disease other than asthma
- Confounding comorbidities such as eosinophilic granulomatosis with polyangiitis (EGPA) or hypereosinophilic syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 months
Participants treated with mepolizumab are observed over time with assessments at baseline and every 6 months to record clinical, physiological, and inflammatory features.
Visits at baseline, 6, 12, 18, and 24 months
Duration - Up to 24 months
Participants are assessed each time they experience a moderate or severe asthma exacerbation during the treatment period to determine the type of inflammatory exacerbation based on sputum analysis.
Visits as exacerbations occur
Trial Site Locations
Total: 1 location
1
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, Canada, G6K 1L8
Actively Recruiting
Research Team
M
Marie-Eve Boulay, MSc
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here