Similarities and Differences of Biological Therapies for Severe Asthma.

Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Study ID
NCT04665141
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mepolizumab — BIOLOGICAL
    Mepolizumab will be prescribed freely by the treating physician according to real-life conditions.
  • Omalizumab — BIOLOGICAL
    Omalizumab will be prescribed freely by the treating physician according to real-life conditions.
  • Reslizumab — BIOLOGICAL
    Reslizumab will be prescribed freely by the treating physician according to real-life conditions.
  • Benralizumab — BIOLOGICAL
    Benralizumab will be prescribed freely by the treating physician according to real-life conditions.
  • Dupilumab — BIOLOGICAL
    Dupilumab will be prescribed freely by the treating physician according to real-life conditions.

Study Details

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.

Key Dates

Start date
Apr 7, 2021
Status verified
Dec 2020
Primary completion
Nov 30, 2022
Completion
Nov 30, 2022

Study Design

Enrollment
600 participants (estimated)

Arms

  • Arm: Standard of care
    Patients with severe asthma being treated with non-biological standard therapies, mainly systemic corticosteroids.
  • Arm: Biological therapies
    Patients with severe asthma being treated with omalizumab, mepolizumab, reslizumab, benralizumab, or dupilumab.

Primary Outcome Measure

Treatment dose scheduling and changes of dose throughout the study. [ Time Frame: 2 years after inclusion ]

Central Contacts

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