Efficacy of Mepolizumab in Polish Patients With Severe Eosinophilic Asthma
NCT ID: NCT05091385
Last Updated: 2021-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
130 participants
OBSERVATIONAL
2021-11-01
2021-12-31
Brief Summary
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* 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
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In addition the following parameters which are available in patients' records will be analysed:
* 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 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 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
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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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
Mepolizumab given SC 100mg every 4 weeks between Dec 2017 and Dec 2019
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.
Interventions
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Mepolizumab given SC 100mg every 4 weeks between Dec 2017 and Dec 2019
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.
Eligibility Criteria
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Inclusion Criteria
* Duration of treatment with mepolizumab: ≥ 52 weeks
* Age \>18
* High doses of ICS + one other controlling medication (i.e. LABA)
* ≥2 exacerbations in the previous year
* ≥350 eosinophil cells/μl in the blood at the time of qualifying, or in the previous year
* Pre-bronchodilator FEV1 \< 80%
Exclusion Criteria
• Lack of complete data
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Medical University of Lodz
OTHER
Responsible Party
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Principal Investigators
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Marcin Kurowski, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Lodz
Locations
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Medical University of Lodz, Dept. of Immunology and Allergy
Lodz, , Poland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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10867
Identifier Type: -
Identifier Source: org_study_id