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

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 Overview

• Status: Unknown
• Conditions: Severe Eosinophilic Asthma

• Study Type: Observational
• Enrollment (Anticipated): 150

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with uncontrolled severe eosinophilic asthma

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of annual exacerbation rate in patients with severe eosinophilic asthma in treatment with mepolizumab	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	2 years
Quality of life improvement in patients with severe eosinophilic asthma receiving mepolizumab as it measured by Asthma Control Test (ACT)	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	2 years

Collaborators and Investigators

• Sponsor: Attikon Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: September 8, 2019
• First Submitted That Met QC Criteria: September 8, 2019
• First Posted (Actual): September 10, 2019

Study Record Updates

• Last Update Posted (Actual): September 12, 2019
• Last Update Submitted That Met QC Criteria: September 10, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Mepolizumab; Severe Eosinophilic Asthma; Anti-IL5 treatment
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Hematologic Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Leukocyte Disorders; Eosinophilia; Hypereosinophilic Syndrome; Asthma; Pulmonary Eosinophilia
• Other Study ID Numbers: Mepolizumab RWE Study Greece

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No