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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study population | Subjects with severe asthma treated with mepolizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepolizumab | Drug | 100 mg subcutaneous injections every four weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Between baseline and month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline and month 24 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with severe asthma treated with mepolizumab at the IUCPQ-UL a tertiary care center from the Quebec city area.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marie-Eve Boulay, MSc | Contact | 4186568711 | 2617 | marie-eve.boulay@criucpq.ulaval.ca |
| Name | Affiliation | Role |
|---|---|---|
| Andréanne Côté, MD | IUCPQ-UL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut universitaire de cardiologie et de pneumologie de Québec | Recruiting | Québec | Quebec | G6K 1L8 | Canada |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C434107 | mepolizumab |
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| Change from baseline in post-bronchodilator forced expiratory volume in one second (FEV1) at 24 months |
Value of FEV1 measured after inhalation of 400ug of salbutamol. Recorded in Li. (Month 24 FEV1 value - baseline FEV1 value) |
| Baseline and month 24 |
| Change from baseline in post-bronchodilator FEV1/forced vital capacity (FVC) ratio at 24 months | Value of FEV1/FVC measured after inhalation of 400 ug of salbutamol. (Month 24 value - baseline value) | Baseline and month 24 |
| Change from baseline in fraction of exhaled nitric oxide (FeNO) levels at 24 months | Recorded in ppb using the mean of two reproducible measurements. (Month 24 value - baseline value) | Baseline and month 24 |
| Change from baseline in percentage of sputum eosinophils at 24 months | Determined from induced sputum analysis. (Month 24 sputum eosinophil percentages - baseline sputum eosinophil percentages) | Baseline and month 24 |
| Change from baseline in percentage of sputum neutrophils | Determined from induced sputum analysis. (Month 24 sputum neutrophil percentages - baseline sputum neutrophil percentages). | Baseline and month 24 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |