Asthma; EosinophilicNCT05091385
Efficacy of Mepolizumab in Polish Patients With Severe Eosinophilic Asthma
An observational study of Asthma; Eosinophilic, run by Medical University of Lodz at 1 site in Poland.
Trial summary
This study is aimed at evaluation of the efficacy of mepolizumab 100 mg subcutaneously (SC) every 4 weeks in patients with severe eosinophilic asthma who have been treated for at least 12 months in several Polish allergy/asthma centres under the same protocol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma; Eosinophilic
- What is being tested?
- Mepolizumab given SC 100mg every 4 weeks between Dec 2017 and Dec 2019
- How many people
- 106 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2022to 6 Aug 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: 130 Patients who were treated with mepolizumab in six severe-asthma clinics in Poland between December 2017 and December 2019 . In the drug program in Poland it was mandatory to conduct the control examinations at the 24th and 52nd week of treatment. In the proposed study we will use this information to evaluate study endpoints. Only patients who have been treated for at least 52 weeks are included into the study.
Who may be able to join
- The availability of the complete data
- Duration of treatment with mepolizumab: ≥ 52 weeks
- Satisfying the Polish drug programme inclusion criteria:
- Age >18
- Before treatment with mepolizumab (BSAT inclusion criteria):
- High doses of inhaled corticosteroids (ICS) + one other controlling medication (i.e. LABA)
Show all 9Show fewer
- ≥2 exacerbations in the previous year
- ≥350 eosinophil cells/microliter (µl) in the peripheral blood at the time of qualification or in the previous year
- Pre-bronchodilator FEV1 < 80%
Who cannot join
- Duration of treatment with mepolizumab < 52 weeks
- Lack of complete data
Trial locations and contacts
1 site in 1 country.
Poland1 site
Medical University of Lodz, Dept. of Immunology and Allergy
Lodz, 92-213
About this study
Official title: The Efficacy of Mepolizumab in Patients With Severe Eosinophilic Asthma Treated in Poland. The Real-life Observational Study
This study is aimed at evaluation of the efficacy of mepolizumab 100 mg subcutaneously (SC) every 4 weeks in patients with severe eosinophilic asthma who have been treated for at least 12 months in several Polish allergy/asthma centres under the same protocol. Target population to be recruited has been set at 130 subjects from at least 6 asthma centers throughout the country. Data on demographics and asthma status will be collected using questionnaires at 3 time-points: pre-mepolizumab (pre-MEPO), after 24 weeks of mepolizumab (MEPO) and after 1 year of MEPO administration (some of the outcomes will be observed every 4 weeks). Primary endpoints will include:
- Asthma exacerbations measured at qualification for the treatment (in the period of previous 52 weeks) and at the 24th and 52nd week of the treatment.
- Oral Corticosteroids use dose (documented at qualification for the treatment and at the 24th and 52nd week of the treatment).
Read the detailed description
This study is aimed at evaluation of the efficacy of mepolizumab 100 mg SC every 4 weeks in patients with severe eosinophilic asthma who have been treated for at least 12 months in several Polish allergy/asthma centres under the same protocol. Retrospective multicentre observational study will involve 130 patients with severe eosinophilic asthma (SEA) who have been treated in six Severe Asthma Treatment Centres (SATCs) in Poland. In each SATC all data available in the program questionnaires will be transferred to the Study Data Sheet (questionnaire), and will be send to the study coordinator within 5 months from the study beginning The start-up meeting including partners from all centres involved will be organized to discuss the study protocol and to unify data collection The evaluation parameters (exacerbations rate, OCS dose) will be analysed at least at three time points: pre-MEPO, after 24 weeks of MEPO and after 1 year of MEPO administration (some of the outcomes will be observed every 4 weeks, for the details see 'study endpoints' section).
In addition the following parameters which are available in patients' records will be analysed:
- 5-item asthma control questionnaire (ACQ-5) score (measured at qualification for the treatment and every 4 weeks thereafter)
- Asthma quality of life questionnaire (AQLQ) score (measured at qualification for the treatment and every 4 weeks thereafter)
- Pre-bronchodilator FEV1 (measured at qualification for the treatment and every 4 weeks thereafter)
Research activities will include:
- collecting raw data from the clinical centres (paper version) and constructing a raw dataset (digital version),
- data cleaning, computation of variables,
- statistical analysis typical for pre-post study design (the statistical analysis will be outsourced to the specialized private institute).
Clinical improvements observed at 24 weeks and at 52 weeks of treatment with Mepolizumab will be referred to the following characteristics of patients at baseline:
- demographics,
- presence of comorbidities including the atopic status,
- concomitant pharmacotherapy,
- clinical status,
- eosinophilia. We will control for mepolizumab use regarding dose, treatment duration and dosing frequency as well as for the safety profile based on the AEs reporting in the medical documentation.
Data Source / Data Collection Patients recruited to the study had been treated with mepolizumab between December 2017 and December 2019.All the data planned to be used in the proposed study were systematically collected in the form of the clinical documentation (paper version) and will be transferred in the study centres into the study.
Data Sheets. Collaborating Researchers (Severe Asthma Centres' Leaders) will provide the data input into the dedicated online questionnaire.
Study Population 130 Patients who were treated with mepolizumab in six severe-asthma clinics in Poland between December 2017 and December 2019 . In the drug program in Poland it was mandatory to conduct the control examinations at the 24th and 52nd week of the treatment . In the proposed study we will use this information to evaluate study endpoints. Only patients who have been treated for at least 52 weeks are included into the study
Variables concerning the primary endpoints
- Asthma exacerbations measured at qualification for the treatment (in the period of previous 52 weeks) and at the 24th and 52nd week of the treatment.
- Oral Corticosteroids use dose (documented at qualification for the treatment and at the 24th and 52nd week of the treatment)
Variables concerning the secondary endpoints:
- ACQ-5 score (measured at qualification for the treatment and every 4 weeks thereafter)
- AQLQ score (measured at qualification for the treatment and every 4 weeks thereafter)
- Pre-bronchodilator forced expiratory volume in 1 second (FEV1) (measured at qualification for the treatment and every 4 weeks thereafter)
- Blood eosinophil counts (measured at qualification for the treatment and at the 24th and 52nd week of the treatment)
- Conditions
- Asthma; Eosinophilic
- Being tested
- Mepolizumab given SC 100mg every 4 weeks between Dec 2017 and Dec 2019
- Keywords
- severe eosinophilic asthma, eosinophils, biological treatment, anti-interleukin(IL)-5, monoclonal antibody
- Medical subject headings
- Pulmonary Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mepolizumab given SC 100mg every 4 weeks between Dec 2017 and Dec 2019Biological
Mepolizumab administered within the frame of a severe asthma treatment program financed by National Health Fund in Poland for patients fulfilling specific criteria of asthma severity.
| Study group | Role | What they receive |
|---|---|---|
| Severe asthma patients treated with mepolizumab | Patients having received mepolizumab 100 mg SC every 4 weeks for at least 12 months in six severe-asthma clinics in Poland between December 2017 and December 2019 Receives: Biological: Mepolizumab given SC 100mg every 4 weeks between Dec 2017 and Dec 2019 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Exacerbations During 52 Weeks Preceding Treatment Initiation (as Assessed at Baseline) and at the 24th and 52nd Week of the Treatment
Data as transferred from the treatment program questionnaires to the Study Data Sheet. Asthma exacerbations, defined according to the Polish drug programme, is the worsening in asthma requiring (1) use of systemic corticosteroids or (2) increase in dose of OCS for more than 3 days in case of patients who are chronically treated with OCS.
Measured: Baseline (before mepolizumab initiation); week 24; week 52
Number Patients Requiring Treatment With Oral Corticosteroids (OCS) at a Chronic Basis (Documented at Qualification for the Treatment and at the 24th and 52nd Week of the Treatment)
Data as transferred from the treatment program questionnaires to the Study Data Sheet
Measured: Baseline (before mepolizumab initiation); week 24; week 52
Secondary outcomes (4)
ACQ-5 (Asthma Control Questionnaire 5-item) Score
Asthma Control Questionnaire (ACQ) is the validated tool aimed to measure the adequacy of asthma control and change in asthma control occurring either spontaneously or as a result of treatment. It is self-administered by patients and assesses asthma symptoms intensity and frequency (5 items) on a 7-point scale (0 through 6; 0=absence, 6= maximum intensity/frequency), with total score being the average of the questions. ACQ score ranges from 0 (minimum) to 6 (maximum). A score of 1.5 or more indicates that a patient has inadequate asthma control. Difference in score of 0.5 or greater is considered clinically important (MCID, minimal clinically important difference).
Measured: Baseline (before mepolizumab initiation); week 24; week 52
AQLQ (Asthma Quality of Life Questionnaire) Score
Asthma Quality of Life Questionnaire (AQLQ) is a disease-specific tool covering both physical and emotional impact of asthma upon the affected subjects' quality of life. This questionnaire has 4 domains: symptoms, activity limitation, emotional function, and environmental stimuli. The AQLQ has been validated in 2 variants: a standard AQLQ consisting of 32 items and a mini-AQLQ containing 15 items. In the national severe asthma treatment program in Poland a 15-item AQLQ is used, as per National Health Fund requirements. Items are scored on a 7-point Likert scale, with score 1 representing maximal impairment and the value of 7 attributed to "no impairment". The total score is calculated as a mean value of all items (a sum of scores divided by 15). A change of >0.5 points is considered clinically significant. Score below 5 indicates considerable lowering of quality of life in an asthmatic subject and is one of the conditions for inclusion into the reimbursed treatment program.
Measured: Baseline (before mepolizumab initiation); week 24; week 52
Pre-bronchodilator FEV1
Pre-bronchodilator FEV1 (forced expiratory volume in 1 second) is a key indicator in lung funtion testing, measuring the volume of air exhaled from the lungs in the first second of a maximum forced exhalation. FEV1 is commonly used to diagnose and monitor obstructive lung diseases, including asthma. Values below 80% of the predicted value (calculated individually using basing on subject's age, sex, height, weight and ethnicity) indicates narrowing of the airways.
Measured: Baseline (before mepolizumab initiation); week 24; week 52
Blood Eosinophil Counts
Data as transferred from the treatment program questionnaires to the Study Data Sheet
Measured: Baseline (before mepolizumab initiation); week 24; week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start1 Jan 2022
- Primary completion30 Jun 2024
- Study completion6 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Asthma; EosinophilicStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Marcin Kurowski, MD, PhD, Principal investigator, Medical University of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091385
- Sponsor's protocol ID
- 10867
- Status last verified
- Aug 2025
- First submitted
- 12 Oct 2021
- Last updated
- 28 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual entries regarding laboratory results, concomitant medications, comorbidities and clinical features of asthma exacerbations will be made available upon request, as specified below.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Mepolizumab in Patients With Severe Eosinophilic Asthma Treated in Poland. The Real-life Observational Study
- ClinicalTrials.gov ID
- NCT05091385
- Acronym / sponsor ID
- 10867
- Conditions
- Asthma; Eosinophilic
- Keywords
- severe eosinophilic asthma, eosinophils, biological treatment, anti-interleukin(IL)-5, monoclonal antibody
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 6 Aug 2025 (actual)
- First posted
- 25 Oct 2021 (actual)
- Results
- Posted 28 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is aimed at evaluation of the efficacy of mepolizumab 100 mg subcutaneously (SC) every 4 weeks in patients with severe eosinophilic asthma who have been treated for at least 12 months in several Polish allergy/asthma centres under the same protocol. Target population to be recruited has been set at 130 subjects from at least 6 asthma centers throughout the country. Data on demographics and asthma status will be collected using questionnaires at 3 time-points: pre-mepolizumab (pre-MEPO), after 24 weeks of mepolizumab (MEPO) and after 1 year of MEPO administration (some of the outcomes will be observed every 4 weeks). Primary endpoints will include:
- Asthma exacerbations measured at qualification for the treatment (in the period of previous 52 weeks) and at the 24th and 52nd week of the treatment.
- Oral Corticosteroids use dose (documented at qualification for the treatment and at the 24th and 52nd week of the treatment).
Detailed description
This study is aimed at evaluation of the efficacy of mepolizumab 100 mg SC every 4 weeks in patients with severe eosinophilic asthma who have been treated for at least 12 months in several Polish allergy/asthma centres under the same protocol. Retrospective multicentre observational study will involve 130 patients with severe eosinophilic asthma (SEA) who have been treated in six Severe Asthma Treatment Centres (SATCs) in Poland. In each SATC all data available in the program questionnaires will be transferred to the Study Data Sheet (questionnaire), and will be send to the study coordinator within 5 months from the study beginning The start-up meeting including partners from all centres involved will be organized to discuss the study protocol and to unify data collection The evaluation parameters (exacerbations rate, OCS dose) will be analysed at least at three time points: pre-MEPO, after 24 weeks of MEPO and after 1 year of MEPO administration (some of the outcomes will be observed every 4 weeks, for the details see 'study endpoints' section).
In addition the following parameters which are available in patients' records will be analysed:
- 5-item asthma control questionnaire (ACQ-5) score (measured at qualification for the treatment and every 4 weeks thereafter)
- Asthma quality of life questionnaire (AQLQ) score (measured at qualification for the treatment and every 4 weeks thereafter)
- Pre-bronchodilator FEV1 (measured at qualification for the treatment and every 4 weeks thereafter)
Research activities will include:
- collecting raw data from the clinical centres (paper version) and constructing a raw dataset (digital version),
- data cleaning, computation of variables,
- statistical analysis typical for pre-post study design (the statistical analysis will be outsourced to the specialized private institute).
Clinical improvements observed at 24 weeks and at 52 weeks of treatment with Mepolizumab will be referred to the following characteristics of patients at baseline:
- demographics,
- presence of comorbidities including the atopic status,
- concomitant pharmacotherapy,
- clinical status,
- eosinophilia. We will control for mepolizumab use regarding dose, treatment duration and dosing frequency as well as for the safety profile based on the AEs reporting in the medical documentation.
Data Source / Data Collection Patients recruited to the study had been treated with mepolizumab between December 2017 and December 2019.All the data planned to be used in the proposed study were systematically collected in the form of the clinical documentation (paper version) and will be transferred in the study centres into the study.
Data Sheets. Collaborating Researchers (Severe Asthma Centres' Leaders) will provide the data input into the dedicated online questionnaire.
Study Population 130 Patients who were treated with mepolizumab in six severe-asthma clinics in Poland between December 2017 and December 2019 . In the drug program in Poland it was mandatory to conduct the control examinations at the 24th and 52nd week of the treatment . In the proposed study we will use this information to evaluate study endpoints. Only patients who have been treated for at least 52 weeks are included into the study
Variables concerning the primary endpoints
- Asthma exacerbations measured at qualification for the treatment (in the period of previous 52 weeks) and at the 24th and 52nd week of the treatment.
- Oral Corticosteroids use dose (documented at qualification for the treatment and at the 24th and 52nd week of the treatment)
Variables concerning the secondary endpoints:
- ACQ-5 score (measured at qualification for the treatment and every 4 weeks thereafter)
- AQLQ score (measured at qualification for the treatment and every 4 weeks thereafter)
- Pre-bronchodilator forced expiratory volume in 1 second (FEV1) (measured at qualification for the treatment and every 4 weeks thereafter)
- Blood eosinophil counts (measured at qualification for the treatment and at the 24th and 52nd week of the treatment)
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe asthma patients treated with mepolizumab | – | Biological: Mepolizumab given SC 100mg every 4 weeks between Dec 2017 and Dec 2019Patients having received mepolizumab 100 mg SC every 4 weeks for at least 12 months in six severe-asthma clinics in Poland between December 2017 and December 2019 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 130 Patients who were treated with mepolizumab in six severe-asthma clinics in Poland between December 2017 and December 2019 . In the drug program in Poland it was mandatory to conduct the control examinations at the 24th and 52nd week of treatment. In the proposed study we will use this information to evaluate study endpoints. Only patients who have been treated for at least 52 weeks are included into the study.
Key inclusion criteria (9 listed)
- The availability of the complete data
- Duration of treatment with mepolizumab: ≥ 52 weeks
- Satisfying the Polish drug programme inclusion criteria:
- Age >18
- Before treatment with mepolizumab (BSAT inclusion criteria):
Key exclusion criteria (2 listed)
- Duration of treatment with mepolizumab < 52 weeks
- Lack of complete data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mepolizumab given SC 100mg every 4 weeks between Dec 2017 and Dec 2019Mepolizumab administered within the frame of a severe asthma treatment program financed by National Health Fund in Poland for patients fulfilling specific criteria of asthma severity. | Biological | Severe asthma patients treated with mepolizumab |
Primary outcome
Asthma Exacerbations During 52 Weeks Preceding Treatment Initiation (as Assessed at Baseline) and at the 24th and 52nd Week of the Treatment
Time frame: Baseline (before mepolizumab initiation); week 24; week 52
Data as transferred from the treatment program questionnaires to the Study Data Sheet. Asthma exacerbations, defined according to the Polish drug programme, is the worsening in asthma requiring (1) use of systemic corticosteroids or (2) increase in dose of OCS for more than 3 days in case of patients who are chronically treated with OCS.
Number Patients Requiring Treatment With Oral Corticosteroids (OCS) at a Chronic Basis (Documented at Qualification for the Treatment and at the 24th and 52nd Week of the Treatment)
Time frame: Baseline (before mepolizumab initiation); week 24; week 52
Data as transferred from the treatment program questionnaires to the Study Data Sheet
4 secondary outcomes
ACQ-5 (Asthma Control Questionnaire 5-item) Score
Time frame: Baseline (before mepolizumab initiation); week 24; week 52
AQLQ (Asthma Quality of Life Questionnaire) Score
Time frame: Baseline (before mepolizumab initiation); week 24; week 52
Pre-bronchodilator FEV1
Time frame: Baseline (before mepolizumab initiation); week 24; week 52
Blood Eosinophil Counts
Time frame: Baseline (before mepolizumab initiation); week 24; week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual entries regarding laboratory results, concomitant medications, comorbidities and clinical features of asthma exacerbations will be made available upon request, as specified below.
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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.
Marcin Kurowski, MD, PhD principal investigator
Medical University of Lodz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma; Eosinophilic, run by Medical University of Lodz at 1 site in Poland.
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 9 inclusion and 2 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: finished, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 28 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Asthma Exacerbations During 52 Weeks Preceding Treatment Initiation (as Assessed at Baseline) and at the 24th and 52nd Week of the Treatment (time frame: Baseline (before mepolizumab initiation); week 24; week 52). 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?
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 28 Jan 2026.