Asthma
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALDupilumab
Dupilumab will be prescribed freely by the treating physician according to real-life conditions.
BIOLOGICALMepolizumab
Mepolizumab will be prescribed freely by the treating physician according to real-life conditions.
BIOLOGICALOmalizumab
Omalizumab will be prescribed freely by the treating physician according to real-life conditions.
BIOLOGICALReslizumab
Reslizumab will be prescribed freely by the treating physician according to real-life conditions.
BIOLOGICALBenralizumab
Benralizumab will be prescribed freely by the treating physician according to real-life conditions.
Sponsors
Hospital Clinic of Barcelona
Hospital Regional de Malaga
Clinica Universidad de Navarra, Universidad de Navarra
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Individuals of any age: adults and children. * Diagnosis of severe asthma as given by the treating physician, and defined as an asthma that remains uncontrolled in despite adherence with maximal optimized therapy and treatment of contributed factors, or asthma that worsens when high dose treatment is decreased. * Being treated or not (control group) with biological drugs. * Signed Informed Consent.
Exclusion criteria
* None.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment dose scheduling and changes of dose throughout the study. | 2 years after inclusion | — |
| Number of treatment discontinuations and causes of interruption throughout the study. | 2 years after inclusion | — |
| Incidence of Relevant Treatment-Related Adverse Events recorded throughout the study. | 2 years after inclusion | — |
| Severity of Treatment-Related Adverse Events recorded throughout the study. | 2 years after inclusion | — |
| Change of asthma control during the treatment. | 2 years after inclusion | Number of asthma exacerbations, change in FEV1, ACT, and blood eosinophilia, need of add-on medication, inhaled medication and systemic corticosteroids. |
Countries
Spain
Contacts
Primary ContactMarta López de Calle
Outcome results
None listed