Asthma
Conditions
Keywords
asthma
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.
Interventions
BIOLOGICALBenralizumab
Benralizumab subcutaneously on study day 0 until study week 16 day 1 inclusive
OTHERPlacebo
Placebo subcutaneously on study week 0 until study week 16 day 1 inclusive
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Percent of Eosinophils in Sputum 7 Hours Post Allergen Challenge | 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 |
| Maximal Percentage Decrease in Forced Expiratory Volume in 1 Second 3-7 Hours Post Allergen Challenge | 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) |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Benra 30mg q.4 Week Benralizumab 30mg every 4 Weeks | 23 |
| Placebo Placebo every 4 Weeks | 23 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Benra 30mg q.4 Week | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 30.4 Years STANDARD_DEVIATION 12.3 | 31.5 Years STANDARD_DEVIATION 13.3 | 30.9 Years STANDARD_DEVIATION 12.7 |
| Age, Customized >=18 - <=50 | 20 Participants | 20 Participants | 40 Participants |
| Age, Customized >50 - <=65 | 3 Participants | 3 Participants | 6 Participants |
| Age, Customized >65 - <=75 | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 6 Participants | 3 Participants | 9 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 16 Participants | 19 Participants | 35 Participants |
| Sex: Female, Male Female | 14 Participants | 20 Participants | 34 Participants |
| Sex: Female, Male Male | 9 Participants | 3 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 23 |
| other Total, other adverse events | 7 / 23 | 14 / 23 |
| serious Total, serious adverse events | 0 / 23 | 0 / 23 |
Outcome results
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
Time frame: From prechallenge to 7 hours post allergen challenge during week 9
Population: Primary Efficacy Analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Benra 30mg q.4 Weeks | Change in Percent of Eosinophils in Sputum 7 Hours Post Allergen Challenge | 0.822 Percent | Standard Deviation 4.054 |
| Placebo | Change in Percent of Eosinophils in Sputum 7 Hours Post Allergen Challenge | 6.468 Percent | Standard Deviation 9.56 |
p-value: 0.020895% CI: [-10.69, -0.94]Mixed Models Analysis
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)
Time frame: From prechallenge to 3 to 7 hours post allergen challenge during week 9
Population: Primary Efficacy Analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Benra 30mg q.4 Weeks | Maximal Percentage Decrease in Forced Expiratory Volume in 1 Second 3-7 Hours Post Allergen Challenge | 15.152 Percent | Standard Deviation 8.834 |
| Placebo | Maximal Percentage Decrease in Forced Expiratory Volume in 1 Second 3-7 Hours Post Allergen Challenge | 16.275 Percent | Standard Deviation 10.235 |
p-value: 0.36395% CI: [-3.045, 8.116]Mixed Models Analysis