Severe Eosinophilic AsthmaNCT04084613
Mepolizumab: Real World Evidence Study for the Treatment of Severe Eosinophilic Asthma in Greece
An observational study of Severe Eosinophilic Asthma, run by Attikon Hospital.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Eosinophilic Asthma
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with uncontrolled severe eosinophilic asthma
Who may be able to join
- 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
Who cannot join
- Patient refusal to participate in the study
About this study
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.
- Conditions
- Severe Eosinophilic Asthma
- Keywords
- Severe Eosinophilic Asthma, Mepolizumab, Anti-IL5 treatment
- Medical subject headings
- Pulmonary Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study startJan 2017
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe Eosinophilic AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stylianos Loukides, Attikon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04084613
- Sponsor's protocol ID
- Mepolizumab RWE Study Greece
- Status last verified
- Sep 2019
- First submitted
- 8 Sep 2019
- Last updated
- 12 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Papaioannou AI, Kallieri M, Zervas E, Fouka E, Porpodis K, Hadji Mitrova M, Tzortzaki E, Makris M, Ntakoula M, Lyberopoulos P, Dimakou K, Koukidou S, Ampelioti S, Papaporfyriou A, Katsoulis K, Kipourou M, Rovina N, Antoniou K, Vittorakis S, Bakakos P, Steiropoulos P, Markopoulou K, Avarlis P, Papanikolaou IotaC, Markatos M, Gaki E, Samitas K, Glynos K, Papiris SA, Papakosta D, Tzanakis N, Gaga M, Kostikas K, Loukides S. Clinical remission in patients with severe eosinophilic asthma treated with mepolizumab: A post-hoc analysis of RELIght study. Allergy Asthma Proc. 2025 Jan 1;46(1):45-51. doi: 10.2500/aap.2025.46.240084.
PubMed 39741370
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mepolizumab: Real World Evidence Study for the Treatment of Severe Eosinophilic Asthma in Greece
- ClinicalTrials.gov ID
- NCT04084613
- Acronym / sponsor ID
- Mepolizumab RWE Study Greece
- Conditions
- Severe Eosinophilic Asthma
- Keywords
- Severe Eosinophilic Asthma, Mepolizumab, Anti-IL5 treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 10 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with uncontrolled severe eosinophilic asthma
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Patient refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
- Derived from this study: PubMed 39741370Papaioannou AI, Kallieri M, Zervas E, Fouka E, Porpodis K, Hadji Mitrova M, Tzortzaki E, Makris M, Ntakoula M, Lyberopoulos P, Dimakou K, Koukidou S, Ampelioti S, Papaporfyriou A, Katsoulis K, Kipourou M, Rovina N, Antoniou K, Vittorakis S, Bakakos P, Steiropoulos P, Markopoulou K, Avarlis P, Papanikolaou IotaC, Markatos M, Gaki E, Samitas K, Glynos K, Papiris SA, Papakosta D, Tzanakis N, Gaga M, Kostikas K, Loukides S. Clinical remission in patients with severe eosinophilic asthma treated with mepolizumab: A post-hoc analysis of RELIght study. Allergy Asthma Proc. 2025 Jan 1;46(1):45-51. doi: 10.2500/aap.2025.46.240084.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Eosinophilic Asthma, run by Attikon Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of annual exacerbation rate in patients with severe eosinophilic asthma in treatment with mepolizumab (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04084613, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2019.