Efficacy of Mepolizumab in Polish Patients With Severe Eosinophilic Asthma
Sponsored by Medical University of Lodz
About this trial
Last updated 4 years ago
Study ID
10867
Status
Unknown status
Type
Observational
Placebo
No
Accepting
18+ Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 3 years ago
What is this trial about?
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).
What are the participation requirements?
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