Benralizumab
BiologicalBenralizumab subcutaneously on study day 0 until study week 16 day 1 inclusive
NCT Number: NCT02821416
This is a randomized, double-blind, parallel group, placebo-controlled study designed to evaluate the effect of a fixed 30 mg dose of benralizumab administered subcutaneously every 4 weeks on allergen-induced inflammation in subjects with mild atopic asthma challenged with an inhaled allergen.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 3
Research Site, Calgary, Alberta, Canada
This randomized, double-blind, parallel group, placebo-controlled study will evaluate the effect of a fixed 30 mg dose of benralizumab administered subcutaneously every 4 weeks for 3 doses on allergen-induced inflammation in subjects with mild atopic asthma challenged with an inhaled allergen.
Approximately 38 non-smoking men and women (18 - 65 years of age) corticosteroid-free (oral and inhaled) mild, atopic asthmatics who have demonstrated a dual (early and late) asthmatic response to inhaled allergen challenge at screening will be recruited to complete the study.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Benralizumab subcutaneously on study day 0 until study week 16 day 1 inclusive
Placebo subcutaneously on study week 0 until study week 16 day 1 inclusive
Time frame: From prechallenge to 7 hours post allergen challenge during week 9
To evaluate the effect of benralizumab on allergen-induced increases in eosinophils in induced sputum
Time frame: From prechallenge to 3 to 7 hours post allergen challenge during week 9
To evaluate the effect of benralizumab on the allergen-induced late (3-7 hours post challenge) asthmatic response (LAR)
AstraZeneca
Industry
A Double-Blind, Randomized, Parallel Group, Placebo-Controlled Multi-Centre Study to Evaluate the Effect of Benralizumab on Allergen-Induced Inflammation in Mild, Atopic Asthmatics
Acronym: ARIA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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