NCT04665141

Similarities and Differences of Biological Therapies for Severe Asthma.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

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

• Asthma

Interventions

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

Timeline

• Start date: 2021-04-07
• Primary completion: 2022-11-01
• Completion: 2022-11-01
• First posted: 2020-12-11
• Last updated: 2021-04-27

Locations

1 site across 1 country: Spain

Regulatory

• FDA-regulated drug study