Similarities and Differences of Biological Therapies for Severe Asthma.
NCT ID: NCT04665141
Last Updated: 2021-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
600 participants
OBSERVATIONAL
2021-04-07
2022-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Standard of care
Patients with severe asthma being treated with non-biological standard therapies, mainly systemic corticosteroids.
No interventions assigned to this group
Biological therapies
Patients with severe asthma being treated with omalizumab, mepolizumab, reslizumab, benralizumab, or dupilumab.
Mepolizumab
Mepolizumab will be prescribed freely by the treating physician according to real-life conditions.
Omalizumab
Omalizumab will be prescribed freely by the treating physician according to real-life conditions.
Reslizumab
Reslizumab will be prescribed freely by the treating physician according to real-life conditions.
Benralizumab
Benralizumab will be prescribed freely by the treating physician according to real-life conditions.
Dupilumab
Dupilumab will be prescribed freely by the treating physician according to real-life conditions.
Interventions
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Mepolizumab
Mepolizumab will be prescribed freely by the treating physician according to real-life conditions.
Omalizumab
Omalizumab will be prescribed freely by the treating physician according to real-life conditions.
Reslizumab
Reslizumab will be prescribed freely by the treating physician according to real-life conditions.
Benralizumab
Benralizumab will be prescribed freely by the treating physician according to real-life conditions.
Dupilumab
Dupilumab will be prescribed freely by the treating physician according to real-life conditions.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
ALL
No
Sponsors
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Hospital Clinic of Barcelona
OTHER
Hospital Regional de Malaga
OTHER
Clinica Universidad de Navarra, Universidad de Navarra
OTHER
Responsible Party
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Locations
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Hospital Civil-Hospital Regional Universitario de Málaga
Málaga, , Spain
Countries
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Central Contacts
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Facility Contacts
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Mª José Torres
Role: primary
Other Identifiers
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BIO-ALER-2021-01
Identifier Type: -
Identifier Source: org_study_id
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