Chinook
Can Lung Airways Be Changed?
Purpose
To investigate the effect of treatment with benralizumab on features of airway remodeling, airway physiology and airway inflammation in adult subjects with severe eosinophilic asthma.
Study Design
After the initial 4–6-week screening period, the treatment period last 48-weeks. Afterwards, there will be a 4-week follow-up period for participants. The study will last for a total of 56 - 58 weeks.
A Phase 4, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate the Effect of Benralizumab on Structural and Lung Function Changes in Severe Eosinophilic Asthmatics
Key Inclusion
Age 18-65 with asthma diagnosis
Continuous treatment with medium/high dose ICS plus LABA with or without additional controller.
Pre-BD FEV1 <80 of PNV within 12 months prior to screening. Pre BD FEV1 will be evaluated during screening process to meet eligibility.
Elevated blood eosinophil count.
Key Exclusion
History of lung or other cancer (Participants who have had basal cell carcinoma, skin or cervical cancer are eligible to participate in the study if therapy was completed at least 12 months prior to Visit 1.)
Chronic pulmonary disease other than asthma (lung infection, cystic fibrosis)
Current smoker
Previously received Benralizumab (Fasenra).
Compensation
All study medications and tests are included at no charge to participants. Additional travel reimbursement and compensation will be discussed at the screening visit.
Additional Info
HUM00196809