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| Name | Class |
|---|---|
| Hospital Clinic of Barcelona | OTHER |
| Hospital Regional de Malaga | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care | Patients with severe asthma being treated with non-biological standard therapies, mainly systemic corticosteroids. | ||
| Biological therapies | Patients with severe asthma being treated with omalizumab, mepolizumab, reslizumab, benralizumab, or dupilumab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepolizumab | Biological | Mepolizumab will be prescribed freely by the treating physician according to real-life conditions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Number of asthma exacerbations, change in FEV1, ACT, and blood eosinophilia, need of add-on medication, inhaled medication and systemic corticosteroids. | 2 years after inclusion |
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Inclusion Criteria:
Exclusion Criteria:
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All patients, adults and children, with a diagnosis of severe asthma in the participating centers.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marta López de Calle | Contact | +34948425600 | mlopezdecal@unav.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Civil-Hospital Regional Universitario de Málaga | Recruiting | Málaga | 29009 | Spain |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C434107 | mepolizumab |
| D000069444 | Omalizumab |
| C515492 | reslizumab |
| C571386 | benralizumab |
| C582203 | dupilumab |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| Omalizumab | Biological | Omalizumab will be prescribed freely by the treating physician according to real-life conditions. |
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| Reslizumab | Biological | Reslizumab will be prescribed freely by the treating physician according to real-life conditions. |
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| Benralizumab | Biological | Benralizumab will be prescribed freely by the treating physician according to real-life conditions. |
|
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| Dupilumab | Biological | Dupilumab will be prescribed freely by the treating physician according to real-life conditions. |
|
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |