- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04084613
Mepolizumab: Real World Evidence Study for the Treatment of Severe Eosinophilic Asthma in Greece
September 10, 2019 updated by: Stylianos Loukides, Attikon Hospital
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
Study Type
Observational
Enrollment (Anticipated)
150
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
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
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
|
2 years
|
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
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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-
AstraZenecaCompletedSevere Eosinophilic AsthmaSwitzerland
-
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