A Pragmatic Study to Investigate the Efficacy and Safety of Mepolizumab in Severe Uncontrolled Asthma in Brazil
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
The anti-interleukin-5 monoclonal antibody mepolizumab is approved as an add-on therapy in
Europe, Canada, USA, and other countries, to standard of care for the treatment of patients
with severe eosinophilic asthma. Mepolizumab has been shown to reduce exacerbation rates and
dependency on oral corticosteroid use in clinical trials in patients with severe eosinophilic
asthma compared with placebo, both in addition to standard of care. Other trials had also
showed that treatment with mepolizumab resulted in significant improvements in quality of
life (SGRQ) and asthma control (ACQ-5 score) . Mepolizumab has only recently been approved in
Brazil. There is still no data regarding its efficacy and safety in the Brazilian population
and it is important to emphasize that no Brazilian center participated in the previous large,
international and multicentric phase III mepolizumab studies. Therefore, it is crucial to
perform a local study in order to validate external results in the Brazilian population.