This is an ambispective multicenter longitudinal observational study to evaluate the efficacy and safety profile of biological therapies in patients diagnosed with severe asthma in real life conditions.
The use of biologicals to treat severe asthma has been implemented in a regular basis while information on long term effectiveness and safety is lacking. It is necessary to establish strategies to closely monitor the possible occurrence of reactions, adverse effects of innovative biological medicines used to treat severe asthma. In this study the investigators want to evaluate the comparative effectiveness, utilization patterns, long-term safety, and use in special groups in real-life conditions in severe asthma.
Study Type
OBSERVATIONAL
Enrollment
600
Mepolizumab will be prescribed freely by the treating physician according to real-life conditions.
Omalizumab will be prescribed freely by the treating physician according to real-life conditions.
Reslizumab will be prescribed freely by the treating physician according to real-life conditions.
Hospital Civil-Hospital Regional Universitario de Málaga
Málaga, Spain
RECRUITINGTreatment dose scheduling and changes of dose throughout the study.
Time frame: 2 years after inclusion
Number of treatment discontinuations and causes of interruption throughout the study.
Time frame: 2 years after inclusion
Incidence of Relevant Treatment-Related Adverse Events recorded throughout the study.
Time frame: 2 years after inclusion
Severity of Treatment-Related Adverse Events recorded throughout the study.
Time frame: 2 years after inclusion
Change of asthma control during the treatment.
Number of asthma exacerbations, change in FEV1, ACT, and blood eosinophilia, need of add-on medication, inhaled medication and systemic corticosteroids.
Time frame: 2 years after inclusion
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Benralizumab will be prescribed freely by the treating physician according to real-life conditions.
Dupilumab will be prescribed freely by the treating physician according to real-life conditions.