Clinical trial NCT04578171: Residual Exacerbations With Mepolizumab
Official title: Type and Mechanisms of Residual Asthma Exacerbations in Patients Treated With Mepolizumab
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Asthma
Keywords: exacerbation
inflammation
monoclonal antibody
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2020-10-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe asthma treated with mepolizumab at the IUCPQ-UL a tertiary care center from the Quebec city area.

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.

Detailed description: 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

Eligibility 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

Primary outcomes:
measure: Proportion of eosinophilic vs non-eosinophilic remaining exacerbation during the treatment period
timeFrame: Between baseline and month 24
Secondary outcomes:
measure: Change from baseline in asthma control on the Asthma Control Questionnaire (ACQ-5) at 24 months
timeFrame: Baseline and month 24
measure: Change from baseline in post-bronchodilator forced expiratory volume in one second (FEV1) at 24 months
timeFrame: Baseline and month 24
measure: Change from baseline in post-bronchodilator FEV1/forced vital capacity (FVC) ratio at 24 months
timeFrame: Baseline and month 24
measure: Change from baseline in fraction of exhaled nitric oxide (FeNO) levels at 24 months
timeFrame: Baseline and month 24
measure: Change from baseline in percentage of sputum eosinophils at 24 months
timeFrame: Baseline and month 24
measure: Change from baseline in percentage of sputum neutrophils
timeFrame: Baseline and month 24
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Institut universitaire de cardiologie et de pneumologie de Québec
state: Quebec
Study officials:
affiliation: IUCPQ-UL
name: Andréanne Côté, MD
role: PRINCIPAL_INVESTIGATOR
References: