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

Severe Eosinophilic Asthma Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04084613
• Other study ID #: Mepolizumab RWE Study Greece
• Status: Active, not recruiting
• Start date: January 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: September 2019
• Source: Attikon Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ß2 stimulants

Exclusion Criteria:

• Patient refusal to participate in the study

Related Conditions & MeSH terms

• Asthma
• Pulmonary Eosinophilia
• Severe Eosinophilic Asthma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Attikon Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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