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

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ClinicalTrials.gov Identifier: NCT02821416
Recruitment Status : Active, not recruiting
First Posted : July 1, 2016
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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.

Condition or disease Intervention/treatment Phase
Asthma Biological: Benralizumab Other: Placebo Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : October 11, 2016
Estimated Primary Completion Date : October 23, 2019
Estimated Study Completion Date : October 23, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Benralizumab
Benralizumab administered subcutaneously
Biological: Benralizumab
Benralizumab subcutaneously on study day 0 until study week 16 day 1 inclusive

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




Primary Outcome Measures :
  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)


Secondary Outcome Measures :
  1. Change in percent of basophil numbers in induced sputum [ Time Frame: From prechallenge to 24 hours post challenge during week 9 ]
    To assess the effect of benralizumab on allergen-induced increases in number of basophils in induced sputum

  2. Maximal percentage decrease in FEV1 0-2 hours post allergen challenge [ Time Frame: From prechallenge to 2 hours post allergen challenge during week 9 ]
    To assess the effect of benralizumab on allergen-induced early (within 2 hours post allergen challenge) asthmatic response (EAR)

  3. AUC of time adjusted percent decrease in FEV1 curve in early asthmatic response (EAR) [ Time Frame: From prechallenge to 2 hours post allergen challenge during week 9 ]
    To assess the effect of benralizumab on allergen-induced early (within 2 hrs post allergen challenge) asthmatic response (EAR)

  4. Change in eosinophil and basophil numbers in endobronchial biopsies (in a sub-set of subjects) [ Time Frame: From prechallenge to 24 hours post allergen challenge during week 12 ]
    To assess the effect of benralizumab on allergen-induced increases in number of eosinophils and basophils in lung tissue biopsies

  5. Change in eosinophils, eosinophil progenitor cells and basophils in bone marrow aspirates (bone marrow aspirates in a sub-set of subjects) [ Time Frame: From prechallenge to 24 hours post allergen challenge during week 9 ]
    To assess the effect of benralizumab on allergen-induced increases in eosinophils, eosinophil progenitor cells and basophils in bone marrow aspirates

  6. Change in eosinophils and basophils in blood [ Time Frame: From prechallenge to 24 hours post allergen challenge during week 9 ]
    To assess the effect of benralizumab on allergen-induced increases in eosinophils and basophils in blood

  7. Change in eosinophils and basophils in induced sputum, blood and bone marrow aspirates (in a sub-set of subjects) [ Time Frame: Up to week 9 ]
    To assess the effect of benralizumab on baseline levels of eosinophil and basophil inflammation in sputum, blood and bone marrow aspirates prior to allergen challenge

  8. Change in eosinophils and basophils in endobronchial biopsies (in a sub-set of subjects) [ Time Frame: Up to week 8 ]
    To assess the effect of benralizumab on baseline levels of eosinophil and basophil inflammation in endobronchial biopsies prior to allergen challenge

  9. Methacholine PC20 [ Time Frame: From prechallenge to post allergen challenge during week 9 ]
    To evaluate the effect of benralizumab on airway hyper-responsiveness post allergen challenge

  10. Change in percent of eosinophils in sputum [ Time Frame: From prechallenge to 24 hours post challenge during week 9 ]
    To assess the effect of benralizumab on allergen-induced increases in number of eosinophils in induced sputum


Other Outcome Measures:
  1. Safety and tolerability of benralizumab assessed by the reporting of adverse events/serious adverse events and physical examination/vital signs [ Time Frame: Up to week 20 ]
    To evaluate the safety and tolerability of benralizumab

  2. Safety and tolerability of benralizumab assessed by electrocardiogram and clinical chemistry/haematology/urinalysis [ Time Frame: Up to week 16 ]
    To assess the safety and tolerability of benralizumab



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02821416


Locations
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Canada, Alberta
Research Site
Calgary, Alberta, Canada, T2N 4Z6
Research Site
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Research Site
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
Research Site
Hamilton, Ontario, Canada, L8N 3Z5
Canada, Saskatchewan
Research Site
Saskatoon, Saskatchewan, Canada, S7N 0W8
Canada
Research Site
Quebec, Canada, G1V 4G5
Sponsors and Collaborators
AstraZeneca

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02821416     History of Changes
Other Study ID Numbers: D3250C00040
First Posted: July 1, 2016    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019

Keywords provided by AstraZeneca:
asthma

Additional relevant MeSH terms:
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Inflammation
Pathologic Processes
Benralizumab
Anti-Asthmatic Agents
Respiratory System Agents