Recruiting

Mepolizumab

Sponsor:

Laval University

Code:

NCT04578171

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Mepolizumab

Study Details

Brief 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 period. During these visits, various clinical, physiological and inflammatory outcomes will be assessed.

Conditions

Asthma

Study ID

NCT04578171

Start date

Jul 6, 2021

Status verified date

Feb, 2025

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Study population

Subjects with severe asthma treated with mepolizumab

Interventions

Mepolizumab

100 mg subcutaneous injections every four weeks

Primary outcome measure

  • Proportion of eosinophilic vs non-eosinophilic remaining exacerbation during the treatment period [ Time Frame: Between baseline and month 24 ]

Central Contacts and Locations

Central contacts

Marie-Eve Boulay, MSc

4186568711marie-eve.boulay@criucpq.ulaval.ca

Locations

Institut universitaire de cardiologie et de pneumologie de Québec

Recruiting

Québec, Quebec, Canada, G6K 1L8

Contacts

Andréanne Côté, MD-MSc

4186564747andreanne.cote@criucpq.ulaval.ca

Marie-Eve Boulay

4186568711marie-eve.boulay@criucpq.ulaval.ca

Principal Investigator:

Andréanne Côté, MD-MSc

More Information

Sponsor

Laval University

Last update posted

Feb 10, 2025

Last verified

Feb, 2025

Keywords

  • exacerbation
  • inflammation
  • monoclonal antibody

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laval University on 2025-02-10.