NCT03652376

Impact of Benralizumab Treatment on Circulating Dendritic Cells in Patients With Eosinophilic Asthma

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Rostock · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study investigates the effect of removing eosinophils from peripheral blood (using treatment with Benralizumab, which is approved for the treatment of severe eosoniphilic asthma) on circulating dendritic cells in patients with severe eosinophilic asthma.

Detailed description

Phase III clinical trials demonstrated that benralizumab treatment results in a significant decrease in exacerbations and a significant increase in lung function and quality of life in patients with severe eosinophilic asthma. However, the precise underlying mechanisms leading to this clinical benefit of benralizumab treatment are not completely understood. Dendritic cells are key regulators of the adaptive and innate immune system. There is evidence that eosinophils have a direct influence on the function of dendritic cells. In addition, there are multiple indirect interactions between eosinophils and dendritic cells in asthma. However, there is currently no information on the impact of benralizumab treatment and a complete removal of circulating eosinophils on the number and phenotype of human dendritic cells. Benralizumab is chosen for this study because it is the only anti-IL-5 biologic which results in a complete removal of eosinophils from peripheral blood.

Conditions

• Severe Eosinophilic Asthma

Interventions

Type	Name	Description
DRUG	Benralizumab	Treatment with Benralizumab 30 mg s.c. every 4 weeks (three times)

Timeline

• Start date: 2018-09-01
• Primary completion: 2019-05-01
• Completion: 2019-12-31
• First posted: 2018-08-29
• Last updated: 2018-08-29

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study