Residual Exacerbations With Mepolizumab
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Study population Subjects with severe asthma treated with mepolizumab |
Drug: Mepolizumab
100 mg subcutaneous injections every four weeks
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Proportion of eosinophilic vs non-eosinophilic remaining exacerbation during the treatment period [Between baseline and month 24]
Eosinophilic exacerbation defined as >=3% sputum eosinophils. Ratio of eosinophilic vs non eosinophilic asthma exacerbation
Secondary Outcome Measures
- Change from baseline in asthma control on the Asthma Control Questionnaire (ACQ-5) at 24 months [Baseline and month 24]
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)
- Change from baseline in post-bronchodilator forced expiratory volume in one second (FEV1) at 24 months [Baseline and month 24]
Value of FEV1 measured after inhalation of 400ug of salbutamol. Recorded in Li. (Month 24 FEV1 value - baseline FEV1 value)
- Change from baseline in post-bronchodilator FEV1/forced vital capacity (FVC) ratio at 24 months [Baseline and month 24]
Value of FEV1/FVC measured after inhalation of 400 ug of salbutamol. (Month 24 value - baseline value)
- Change from baseline in fraction of exhaled nitric oxide (FeNO) levels at 24 months [Baseline and month 24]
Recorded in ppb using the mean of two reproducible measurements. (Month 24 value - baseline value)
- Change from baseline in percentage of sputum eosinophils at 24 months [Baseline and month 24]
Determined from induced sputum analysis. (Month 24 sputum eosinophil percentages - baseline sputum eosinophil percentages)
- Change from baseline in percentage of sputum neutrophils [Baseline and month 24]
Determined from induced sputum analysis. (Month 24 sputum neutrophil percentages - baseline sputum neutrophil percentages).
Eligibility Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Laval University
- GlaxoSmithKline
Investigators
- Principal Investigator: Andréanne Côté, MD, IUCPQ-UL
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CÉR21903