Study to Evaluate the Effect of Benralizumab on Allergen-Induced Inflammation in Mild, Atopic Asthmatics

AstraZeneca46 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Asthma

Interventions

BenralizumabBIOLOGICAL

Benralizumab subcutaneously on study day 0 until study week 16 day 1 inclusive

PlaceboOTHER

Placebo subcutaneously on study week 0 until study week 16 day 1 inclusive

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Provision of informed consent prior to any study specific procedures 2. Female or male aged 18 to 65 years, inclusively, at the time of enrolment. 3. General good health 4. Mild, stable, allergic asthma and asthma therapy limited to inhaled, short-acting beta 2 agonists (not more than twice weekly) 5. Positive skin-prick test to at least one common aeroallergen Exclusion Criteria: 1. Current lung disease other than mild allergic asthma 2. Any history or symptoms of disease, including, but not limited to, cardiovascular, neurologic, autoimmune or haematologic 3. Any clinically significant abnormal findings in laboratory test results in complete blood count, coagulation, chemistry panel and urinalysis at enrolment and during screening period 4. History of anaphylaxis to any biologic therapy or vaccine

Locations (6)

Research Site

Calgary, Alberta, Canada

Research Site

Edmonton, Alberta, Canada

Research Site

Vancouver, British Columbia, Canada

Research Site

Hamilton, Ontario, Canada

Outcomes

Primary Outcomes

Change in Percent of Eosinophils in Sputum 7 Hours Post Allergen Challenge

To evaluate the effect of benralizumab on allergen-induced increases in eosinophils in induced sputum

Time frame: From prechallenge to 7 hours post allergen challenge during week 9

Maximal Percentage Decrease in Forced Expiratory Volume in 1 Second 3-7 Hours Post Allergen Challenge

To evaluate the effect of benralizumab on the allergen-induced late (3-7 hours post challenge) asthmatic response (LAR)

Time frame: From prechallenge to 3 to 7 hours post allergen challenge during week 9

Data from ClinicalTrials.gov

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