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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 46
- Locations
- 6
- Primary Endpoint
- Change in Percent of Eosinophils in Sputum 7 Hours Post Allergen Challenge
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Provision of informed consent prior to any study specific procedures
- •Female or male aged 18 to 65 years, inclusively, at the time of enrolment.
- •General good health
- •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
Exclusion Criteria
- •Current lung disease other than mild allergic asthma
- •Any history or symptoms of disease, including, but not limited to, cardiovascular, neurologic, autoimmune or haematologic
- •Any clinically significant abnormal findings in laboratory test results in complete blood count, coagulation, chemistry panel and urinalysis at enrolment and during screening period
- •History of anaphylaxis to any biologic therapy or vaccine
Arms & Interventions
Placebo
Placebo administered subcutaneously
Intervention: Placebo (Other)
Benralizumab
Benralizumab administered subcutaneously
Intervention: Benralizumab (Biological)
Outcomes
Primary Outcomes
Change in Percent of Eosinophils in Sputum 7 Hours Post Allergen Challenge
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
Maximal Percentage Decrease in Forced Expiratory Volume in 1 Second 3-7 Hours Post Allergen Challenge
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)
Secondary Outcomes
No secondary outcomes reported