Reslizumab in Patients With Severe Asthma Who Failed to Respond to Omalizumab
Status:
Completed
Trial end date:
2018-04-30
Target enrollment:
Participant gender:
Summary
Approximately, 5% of the patients with asthma suffer a difficult-to-control severe variant of
the disease. Despite being treated with inhaled corticosteroids (ICs), long-acting
β2-agonists (LABA), oral corticosteroids or omalizumab, one or more components of the control
concept (symptoms, exacerbations, bronchial obstruction) remain to be resolved. Omalizumab
has been proven to safely reduce asthma exacerbations and to decease symptoms and quality of
life in severe allergic asthmatics. However, approximately 25% of the treated patients fail
to respond to this monoclonal antibody. The rest of them show different degrees of response,
although the rate of asthmatics who achieve control of the disease is unknown because
clinical trials of omalizumab have been carried out to assess the impact of the drug on
exacerbations, symptoms or even pulmonary function, but its effect on control was not
evaluated. Therefore, there is a need to find new therapeutic options for those severe
asthmatics who remain uncontrolled despite having received all the recommended therapies
(including omalizumab). Reslizumab is a humanized anti-interleukin-5 (IL-5) monoclonal
antibody (mAb) that has been recently found to reduce exacerbations and to improve pulmonary
function and symptoms in patients with severe asthma and high peripheral eosinophil counts.
It would be important to demonstrate that Reslizumab is able to improve the clinical
condition of severe asthma patients with no therapeutic options.
Phase:
Phase 2
Details
Lead Sponsor:
Sociedad Española de Neumología y Cirugía Torácica