Similarities and Differences of Biological Therapies for Severe Asthma.

University of Navarra

Status

Unknown

Conditions

Asthma

Treatments

Biological: Mepolizumab

Biological: Omalizumab

Biological: Reslizumab

Biological: Benralizumab

Biological: Dupilumab

Study type

Observational

Funder types

Other

Identifiers

NCT04665141

BIO-ALER-2021-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

600 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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