Residual Exacerbations With Mepolizumab
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mepolizumab.
- Who it may be relevant to
- Registry conditions: Asthma. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Type and Mechanisms of Residual Asthma Exacerbations in Patients Treated With Mepolizumab
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.
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
Interventions
- Drug Mepolizumab
100 mg subcutaneous injections every four weeks
Primary outcome measures
- Proportion of eosinophilic vs non-eosinophilic remaining exacerbation during the treatment period [Time frame: Between baseline and month 24]
Secondary outcome measures (6)
- Change from baseline in asthma control on the Asthma Control Questionnaire (ACQ-5) at 24 months [Time frame: Baseline and month 24]
- Change from baseline in post-bronchodilator forced expiratory volume in one second (FEV1) at 24 months [Time frame: Baseline and month 24]
- Change from baseline in post-bronchodilator FEV1/forced vital capacity (FVC) ratio at 24 months [Time frame: Baseline and month 24]
- Change from baseline in fraction of exhaled nitric oxide (FeNO) levels at 24 months [Time frame: Baseline and month 24]
- Change from baseline in percentage of sputum eosinophils at 24 months [Time frame: Baseline and month 24]
- Change from baseline in percentage of sputum neutrophils [Time frame: Baseline and month 24]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Canada · 1 center
- Institut universitaire de cardiologie et de pneumologie de Québec — Québec
Identifiers
NCT: NCT04578171 · CÉR21903