Efficacy of Mepolizumab in Polish Patients With Severe Eosinophilic Asthma

NCT05091385 | Completed Results FDA Drug

• 1 other identifier: 10867
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Asthma; Eosinophilic

Keywords

severe eosinophilic asthma; eosinophils; biological treatment; anti-interleukin(IL)-5; monoclonal antibody

Outcome Measures

Primary Outcomes (2)

• 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.

  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

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

Secondary Outcomes (4)

• ACQ-5 (Asthma Control Questionnaire 5-item) Score

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

• AQLQ (Asthma Quality of Life Questionnaire) Score

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

• Pre-bronchodilator FEV1

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

• Blood Eosinophil Counts

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

Study Arms (1)

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

Biological: Mepolizumab given SC 100mg every 4 weeks between Dec 2017 and Dec 2019

Interventions

Mepolizumab given SC 100mg every 4 weeks between Dec 2017 and Dec 2019 BIOLOGICAL

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.

Severe asthma patients treated with mepolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• \* The availability of the complete data
• Duration of treatment with mepolizumab: ≥ 52 weeks
• Age \>18
• 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%

You may not qualify if:

• \* Duration of treatment with mepolizumab \< 52 weeks
• Lack of complete data

Sponsors & Collaborators

• GlaxoSmithKline: collaborator
• Medical University of Lodz: lead

Study Sites (1)

Medical University of Lodz, Dept. of Immunology and Allergy

Lodz, 92-213, Poland

Location

MeSH Terms

Conditions

Pulmonary Eosinophilia

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypereosinophilic Syndrome; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Limitations and Caveats

Retrospective study, basing on reports from national health data system (as per requirements of national health insurance fund). Incompleteness of data for 24 patients, not possible to be retrieved.

Results Point of Contact

• Title: Marcin Kurowski, MD (PI)
• Organization: Medical University of Lodz, Dept. of Immunology and Allergy

marcin.kurowski@umed.lodz.pl

+48601365911

Study Officials

• Marcin Kurowski, MD, PhD

  Medical University of Lodz

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: October 25, 2021
• Study Start: January 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: August 6, 2025
• Last Updated: January 28, 2026
• Results First Posted: January 28, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Access Criteria: The data may be received upon reasonable written request form the principal investigator.

Locations

PL (1)