Mepolizumab: Real World Evidence Study for the Treatment of Severe Eosinophilic Asthma in Greece

• Conditions: Severe Eosinophilic Asthma

• Registration Number: NCT04084613
• Lead Sponsor: Attikon Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01
• Status Verified: 2019-09
• Study First Submitted: 2019-09-08
• Study First Submitted QC: 2019-09-08
• Study First Posted: 2019-09-10
• Last Update Submitted: 2019-09-10
• Last Update Posted: 2019-09-12
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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