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

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2020

Arms, Groups and Cohorts

  • Patients with uncontrolled severe eosinophilic asthma
    • Asthmatic 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.

Clinical Trial Outcome Measures

Primary Measures

  • Reduction of annual exacerbation rate in patients with severe eosinophilic asthma in treatment with mepolizumab
    • Time Frame: 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)
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Attikon Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Stylianos Loukides, Assistant Professor – Attikon Hospital

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