Actively Recruiting

Age: 18Years - 90Years
All Genders
ID04578171

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

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

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

Monitoring

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

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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

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