N/A
N=106
Efficacy of Mepolizumab in Polish Patients With Severe Eosinophilic Asthma
Asthma; Eosinophilic
Bottom Line
View on ClinicalTrials.gov: NCT05091385 ↗Enrolled (actual)
106
Serious AEs
0.9%
Results posted
Jan 2026
Primary outcome: Primary: Asthma Exacerbations During 52 Weeks Preceding Treatment Initiation (as Assessed at Baseline) and at the 24th and 52nd Week of the Treatment — 3; 0; 0 number of asthma exacerbations
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Mepolizumab given SC 100mg every 4 weeks between Dec 2017 and Dec 2019 (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of Lodz
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Asthma Exacerbations During 52 Weeks Preceding Treatment Initiation (as Assessed at Baseline) and at the 24th and 52nd Week of the Treatment |
3; 0; 0 | — |
| PRIMARY 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) |
70; 20; 15 | — |
| SECONDARY ACQ-5 (Asthma Control Questionnaire 5-item) Score |
3.48; 1.53; 1.31 | — |
| SECONDARY AQLQ (Asthma Quality of Life Questionnaire) Score |
2.47; 5.8; 5.3 | — |
| SECONDARY Pre-bronchodilator FEV1 |
62; 76.0; 76 | — |
| SECONDARY Blood Eosinophil Counts |
605; 60; 60 | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05091385). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.