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NCT Number: NCT02821416

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

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Calgary, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Benralizumab

Biological

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

Placebo

Other

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

Primary outcomes

  1. 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

  2. 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)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 1, 2016
Registry last updated
Jan 7, 2021

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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