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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Benralizumab
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring asthma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Benralizumab

Placebo

Arm Description

Benralizumab administered subcutaneously

Placebo administered subcutaneously

Outcomes

Primary Outcome Measures

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
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)

Secondary Outcome Measures

Full Information

First Posted
June 17, 2016
Last Updated
December 14, 2020
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT02821416
Brief Title
Study to Evaluate the Effect of Benralizumab on Allergen-Induced Inflammation in Mild, Atopic Asthmatics
Acronym
ARIA
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
October 11, 2016 (Actual)
Primary Completion Date
October 22, 2019 (Actual)
Study Completion Date
October 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Benralizumab
Arm Type
Experimental
Arm Description
Benralizumab administered subcutaneously
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered subcutaneously
Intervention Type
Biological
Intervention Name(s)
Benralizumab
Intervention Description
Benralizumab subcutaneously on study day 0 until study week 16 day 1 inclusive
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo subcutaneously on study week 0 until study week 16 day 1 inclusive
Primary Outcome Measure Information:
Title
Change in Percent of Eosinophils in Sputum 7 Hours Post Allergen Challenge
Description
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
Title
Maximal Percentage Decrease in Forced Expiratory Volume in 1 Second 3-7 Hours Post Allergen Challenge
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Research Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Research Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Research Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Research Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Research Site
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada

12. IPD Sharing Statement

Links:
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D3250C00040&attachmentIdentifier=38fb2b0f-090e-4f1a-bfa3-f74c5941c69e&fileName=d3250c00040-csp-4_-_Redacted_(1).pdf&versionIdentifier=
Description
The CSP redacted.
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D3250C00040&attachmentIdentifier=d3ca7f3e-fb89-4822-97f4-85610a3f79cd&fileName=d3250c00040-sap-v2_-_redacted.pdf&versionIdentifier=
Description
The SAP redacted.

Learn more about this trial

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

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