NCT03327701

The Effect of Benralizumab on Exercise-induced Bronchoconstriction

The Effect of Benralizumab on Lung Physiology, Exercise-induced Bronchoconstriction and General Health Status: an Exploratory Mechanistic Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Louis-Philippe Boulet · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Severe asthma affects 5-10% of more than 300 million asthmatics. Ten to twenty percent of individuals suffering from asthma do not respond well to current treatment due to the complexity of the different mechanisms underlying asthma pathogenesis, and sometimes due to an insufficient effect of treatment on underlying airway inflammation. Consequently, some asthmatics have poorer quality of life due to: frequent asthma symptoms, regular medical or emergency visits, limitation in their activities of daily living, including exercise. It is believed that the benralizumab can help to reduce airway inflammation and thus improve exercise tolerance in individuals with asthma. The main objective of this study is to determine the effect of benralizumab on exercise-induced bronchoconstriction (EIB) and exercise tolerance in moderate to severe eosinophilic asthmatics, in comparison with baseline values and a placebo treatment.

Detailed description

Subjects will receive benralizumab every 4 weeks for three doses followed by a fourth dose 8 weeks later. On baseline and after 4, 16 and 20 weeks, subjects will be assess for airway responsiveness to exercise and exercise tolerance.

Conditions

• Asthma, Exercise-Induced

Interventions

Type	Name	Description
DRUG	Benralizumab	Subjects will receive benralizumab 30 mg (subcutaneous) every 4 weeks for three doses followed by a fourth dose 8 weeks later.

Timeline

• Start date: 2017-12-01
• Primary completion: 2019-12-01
• Completion: 2020-04-01
• First posted: 2017-10-31
• Last updated: 2017-10-31