Severe Eosinophilic Asthma
Conditions
Keywords
Severe Eosinophilic Asthma, Mepolizumab, Anti-IL5 treatment
Brief summary
A prospective multi-centre, non-interventional observational study, that will be conducted in several centers in Greece for a 2-year time period (completion date December 2020), to describe patient characteristics, medical history, and the clinical benefit of mepolizumab in patients with severe eosinophilic asthma newly initiated to the drug.
Interventions
None listed
Sponsors
Attikon Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with uncontrolled severe eosinophilic asthma placed under treatment with mepolizumab, i.e. in patients with peripheral blood eosinophils ≥300 cells/μL at any measurement in the previous year or ≥150 cells/μL in a recent measurement, with poor symptom control and increased number of exacerbations (2 or more) despite optimal treatment with high doses of inhaled corticosteroids and β2 stimulants
Exclusion criteria
* Patient refusal to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of annual exacerbation rate in patients with severe eosinophilic asthma in treatment with mepolizumab | 2 years | Reduction of the clinical significant exacerbations in comparison to the year before the initiation of treatment with mepolizumab. A clinical significant exacerbation is an exacerbation that requires treatment as follows: increase of dose of oral corticosteroids intake |
| Quality of life improvement in patients with severe eosinophilic asthma receiving mepolizumab as it measured by Asthma Control Test (ACT) | 2 years | ACT is a 5-point scale that assesses the frequency of shortness of breath and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control. An ACT score 19 or less means that asthma is not well controlled |
Outcome results
None listed