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

Asthma Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02821416
• Other study ID #: D3250C00040
• Status: Completed
• Phase: Phase 3
• Start date: October 11, 2016
• Est. completion date: October 22, 2019

Study information

• Verified date: December 2020
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: October 22, 2019
• Est. primary completion date: October 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Inflammation

Intervention

Biological:
• Benralizumab
Benralizumab subcutaneously on study day 0 until study week 16 day 1 inclusive

Other:
• Placebo
Placebo subcutaneously on study week 0 until study week 16 day 1 inclusive

Locations

Country	Name	City	State
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Hamilton	Ontario
Canada	Research Site	Quebec
Canada	Research Site	Saskatoon	Saskatchewan
Canada	Research Site	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	From prechallenge to 7 hours post allergen challenge during week 9
Primary	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)	From prechallenge to 3 to 7 hours post allergen challenge during week 9

External Links

•   The CSP redacted.
•   The SAP redacted.