NCT02821416

Trial name or title	A double‐bind, randomised, parallel group, placebo‐controlled multi‐centre study to evaluate the effect of benralizumab on allergen‐induced inflammation in mild, atopic asthmatics
Methods	Randomised, double‐blind, parallel‐group, placebo‐controlled study
Participants	Estimated enrolment 42 participants with mild atopic asthma Inclusion criteria Female or male aged 18‐65 years, inclusively, at the time of enrolment Mild, stable, allergic asthma and asthma therapy limited to inhaled, short‐acting beta 2 agonists (not more than twice weekly) Positive skin‐prick test to at least one common aeroallergen
Interventions	Benralizumab administered subcutaneously compared with placebo administered subcutaneously Allergen challenge (all participants)
Outcomes	Primary outcome measures Change in percent of eosinophils in sputum 7 h post allergen challenge Maximal percentage decrease in FEV1 3‐7 h post allergen challenge Secondary outcome measures Change in percent of basophil numbers in induced sputum Maximal percentage decrease in FEV1 0‐2 h post allergen challenge Area under the curve of time‐adjusted percent decrease in FEV1 curve in early asthmatic response Change in eosinophil and basophil numbers in endobronchial biopsies Change in eosinophils, eosinophil progenitor cells and basophils in bone marrow aspirates Change in eosinophils and basophils in blood Change in eosinophils and basophils in induced sputum, blood and bone marrow aspirates Change in eosinophils and basophils in endobronchial biopsies Methacholine PC20 Other outcome measures: Safety and tolerability of benralizumab assessed by the reporting of adverse events/serious adverse events and physical examination/vital signs Safety and tolerability of benralizumab assessed by ECG and clinical chemistry/haematology/urinalysis
Starting date	October 2016
Contact information	AstraZeneca Clinical Study Information Center 1‐877‐240‐9479 information.center@astrazeneca.com
Notes	Still recruiting April 2017 Estimated completion date February 2019

BDP: beclomethasone dipropionate; CO: carbon monoxide; ECG: electrocardiogram; ED: emergency department; eNO: exhaled nitric oxide; FEV₁ : Forced expiratory volume in 1 second; FVC: forced vital capacity; GETE: global evaluation of treatment effectiveness; IC: inspiratory capacity; ICU: intensive care unit; NO: nitric oxide; PC₂₀ : histamine provocative concentration causing a 20% drop in FEV₁: RV: residual volume; TLC: total lung capacity;