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

NCT ID: NCT04084613

Last Updated: 2019-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2020-12-31

Brief Summary

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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

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Conditions

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Severe Eosinophilic Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Attikon Hospital

OTHER

Sponsor Role lead

Responsible Party

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Stylianos Loukides

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Mepolizumab RWE Study Greece

Identifier Type: -

Identifier Source: org_study_id

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