Similarities and Differences of Biological Therapies for Severe Asthma.

NCT ID: NCT04665141

Last Updated: 2021-04-27

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-07

Study Completion Date

2022-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type BIOLOGICAL

Mepolizumab will be prescribed freely by the treating physician according to real-life conditions.

Omalizumab

Intervention Type BIOLOGICAL

Omalizumab will be prescribed freely by the treating physician according to real-life conditions.

Reslizumab

Intervention Type BIOLOGICAL

Reslizumab will be prescribed freely by the treating physician according to real-life conditions.

Benralizumab

Intervention Type BIOLOGICAL

Benralizumab will be prescribed freely by the treating physician according to real-life conditions.

Dupilumab

Intervention Type BIOLOGICAL

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.

Intervention Type BIOLOGICAL

Omalizumab

Omalizumab will be prescribed freely by the treating physician according to real-life conditions.

Intervention Type BIOLOGICAL

Reslizumab

Reslizumab will be prescribed freely by the treating physician according to real-life conditions.

Intervention Type BIOLOGICAL

Benralizumab

Benralizumab will be prescribed freely by the treating physician according to real-life conditions.

Intervention Type BIOLOGICAL

Dupilumab

Dupilumab will be prescribed freely by the treating physician according to real-life conditions.

Intervention Type BIOLOGICAL

Other Intervention Names

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Nucala® Xolair® Cinqair® Fasenra® Dupixent®

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Clinic of Barcelona

OTHER

Sponsor Role collaborator

Hospital Regional de Malaga

OTHER

Sponsor Role collaborator

Clinica Universidad de Navarra, Universidad de Navarra

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Civil-Hospital Regional Universitario de Málaga

Málaga, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Marta López de Calle

Role: CONTACT

+34948425600

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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