Asthma; Eosinophilic Clinical Trial
Official title:
The Efficacy of Mepolizumab in Patients With Severe Eosinophilic Asthma Treated in Poland. The Real-life Observational Study
This study is aimed at evaluation of the efficacy of mepolizumab 100 mg 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 dempgraphics and asthma status will be collected using questionnaires at 3 time-points: pre-MEPO, after 24 weeks of 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 | Not yet recruiting |
Enrollment | 130 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 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: * Duration of treatment with mepolizumab < 52 weeks • Lack of complete data |
Country | Name | City | State |
---|---|---|---|
Poland | Medical University of Lodz, Dept. of Immunology and Allergy | Lodz |
Lead Sponsor | Collaborator |
---|---|
Medical University of Lodz | GlaxoSmithKline |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | 5 months from the study beginning | |
Primary | Oral Corticosteroids use dose (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 | 5 months from the study beginning | |
Secondary | ACQ-5 score (measured at qualification for the treatment and every 4 weeks thereafter) | Data as transferred from the treatment program questionnaires to the Study Data Sheet | 5 months from the study beginning | |
Secondary | AQLQ score (measured at qualification for the treatment and every 4 weeks thereafter) | Data as transferred from the treatment program questionnaires to the Study Data Sheet | 5 months from the study beginning | |
Secondary | Pre-bronchodilator FEV1 (measured at qualification for the treatment and every 4 weeks thereafter) | Data as transferred from the treatment program questionnaires to the Study Data Sheet | 5 months from the study beginning | |
Secondary | Blood eosinophil counts (measured 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 | 5 months from the study beginning |
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