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Impact of Benralizumab Treatment on Circulating Dendritic Cells in Patients With Eosinophilic Asthma | Clinical Trials | Clareo Health

UNKNOWNPHASE4

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

NCT03652376•University of Rostock

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age between 18 and 75 years
•2. Patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting β-agonists.
•3. Documented reversibility of airway obstruction (FEV1 increase ≥ 200 ml and ≥ 15 % after inhalation of a short-acting beta agonist) or bronchial hyperresponsiveness to methacholine or histamine
•4. Documented concentration of blood eosinophils ≥ 300 / µl blood on the day of study inclusion or in the previous 4 weeks before study inclusion
•5. Documented current treatment with high daily doses of ICS plus at least one other asthma controller for at least 3 months at Visit 1.
•6. Disease history: asthma exacerbations while on ICS plus another controller.
•7. ACQ-6 score ≥ 1.5 at Visit 1.
•8. Weight of ≥ 40 kg.
•9. Screening pre-bronchodilator (pre-BD) FEV1 of \< 80% predicted
•10. Women of childbearing potential (WOCBP)(Definition: WOCBP are those women who have not been surgically sterilized or have not been free from menses for \> 2 years) and male study participants have to use adequate contraception methods.

Exclusion Criteria

•1. Smoking history of \> 10 Pack years
•2. Current smoking
•3. Presence of other chronic pulmonary diseases including COPD
•4. Presence of other chronic inflammatory diseases
•5. Treatment with any systemic immunosuppressive drug including prednisolone or biologics
•6. Current pregnancy, breast feeding
•7. Known helminth infections
•8. Acute upper or lower respiratory infections within 30 days prior to the date informed consent is obtained or during the screening/run-in period.
•9. Any disorder, including, but not limited to, cardiovascular, gastrontestinal, hepatic, renal, neurological, musculosceletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could:
•* affect the safety of the patient throughout the study
+18 more criteria

Locations (1)

University of Rostock

Rostock, Mecklenburg-Vorpommern, Germany

Key Dates

Start Date

September 1, 2018

Primary Completion Date

May 1, 2019

Completion Date

December 31, 2019

Last Updated

August 29, 2018

Enrollment

ESTIMATED participants

Conditions

Severe Eosinophilic Asthma

Interventions

Benralizumab

DRUG

Contacts

Marek Lommatzsch, MD

CONTACT

+49-381-494-0 marek.lommatzsch@med.uni-rostock.de

Johann C. Virchow, MD

CONTACT

+49-381-494-0 j.c.virchow@med.uni-rostock.de

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COMPLETEDPHASE4

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 29, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

STEP: Phase IIIb Study of Benralizumab to Step-down Maintenance Therapy in Patients With Severe Eosinophilic Asthma

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