NCT05091385Completed
Efficacy of Mepolizumab in Polish Patients With Severe Eosinophilic Asthma
The Efficacy of Mepolizumab in Patients With Severe Eosinophilic Asthma Treated in Poland. The Real-life Observational Study
Source: ClinicalTrials.gov · Last updated 28 Jan 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 106 (actual)
- First submitted
- 12 Oct 2021
- Start date
- 1 Jan 2022
- Primary completion date
- 30 Jun 2024
- Lead sponsor
- Medical University of Lodz
- Diseases
- Asthma
- NCT number
- NCT05091385
What you commit to
- Study type: Observational
- Participants enrolled: 106
- From 1 Jan 2022 to the primary completion date, 30 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- \* Duration of treatment with mepolizumab \< 52 weeks
Other
- Lack of complete data
Who the study is looking for
- \* 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%
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Lodz, Dept. of Immunology and Allergy Coordinator of this site? Confirm its status | Lodz | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.