Residual Exacerbations With Mepolizumab

Laval University60 enrolled

Overview

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.

Before initiation of mepolizumab, a recording of patient's demographics, clinical, physiological and inflammatory features will be recorded. All subjects will be reassessed for the above measures at 6, 12, 18 and 24 months. In addition to the above visits, patients will be assessed every time they experience either moderate or severe exacerbation of asthma over the treatment period. Based on the percentage of sputum eosinophils and neutrophils, the type of inflammatory exacerbation will be determined

Study Type

OBSERVATIONAL

Enrollment

Conditions

Asthma

Interventions

MepolizumabDRUG

100 mg subcutaneous injections every four weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, Canada

RECRUITING

Outcomes

Primary Outcomes

Proportion of eosinophilic vs non-eosinophilic remaining exacerbation during the treatment period

Eosinophilic exacerbation defined as \>=3% sputum eosinophils. Ratio of eosinophilic vs non eosinophilic asthma exacerbation

Time frame: Between baseline and month 24

Secondary Outcomes

Change from baseline in asthma control on the Asthma Control Questionnaire (ACQ-5) at 24 months

The ACQ-5 is a validated, self-reported questionnaire assessing asthma control over the last week. Possible scores range from 0 (complete control) to 5 (no control). Change = (Month 24 score - baseline score)