CompletedNot Applicable

Efficacy of Mepolizumab in Polish Patients With Severe Eosinophilic Asthma

Poland106 participantsStarted 2022-01-01

Plain-language 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. 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: \* 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) * ≥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% Exclusion Criteria: \* Duration of treatment with mepolizumab \< 52 weeks • Lack of complete data

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Asthma Exacerbations During 52 Weeks Preceding Treatment Initiation (as Assessed at Baseline) and at the 24th and 52nd Week of the Treatment

Timeframe: 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)

Timeframe: Baseline (before mepolizumab initiation); week 24; week 52

Trial details

NCT IDNCT05091385

SponsorMedical University of Lodz

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-06-30

Results submitted2025-10-02

View on ClinicalTrials.gov More Asthma; Eosinophilic trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Asthma Exacerbations During 52 Weeks Preceding Treatment Initiation (as Assessed at Baseline) and at the 24th and 52nd Week of the Treatment

Timeframe: 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)

Timeframe: Baseline (before mepolizumab initiation); week 24; week 52