A Phase 3 interventional study of Benralizumab and Placebo in Asthma, sponsored by AstraZeneca. Completed at 6 sites in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-01-07.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
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.
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.
3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.
This study's enrollment of 46 is close to the median of 50 across 2,437 interventional studies indexed under Inflammation.
Browse Inflammation studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
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Exclusion Criteria:
Benralizumab administered subcutaneously
Biological: Benralizumab
Placebo administered subcutaneously
Other: Placebo
Benralizumab subcutaneously on study day 0 until study week 16 day 1 inclusive
Placebo subcutaneously on study week 0 until study week 16 day 1 inclusive
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
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
| Milestone | Benra 30mg q.4 Week | Placebo |
|---|---|---|
| Started | 23 | 23 |
| Completed | 20 | 22 |
| Not completed | 3 | 1 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Withdrawal by subject | 2 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 |
To evaluate the effect of benralizumab on allergen-induced increases in eosinophils in induced sputum
| Percent | Benra 30mg q.4 Weeks | Placebo |
|---|---|---|
| Change in Percent of Eosinophils in Sputum 7 Hours Post Allergen Challenge | 0.822 ± 4.054 | 6.468 ± 9.560 |
To evaluate the effect of benralizumab on the allergen-induced late (3-7 hours post challenge) asthmatic response (LAR)
| Percent | Benra 30mg q.4 Weeks | Placebo |
|---|---|---|
| Maximal Percentage Decrease in Forced Expiratory Volume in 1 Second 3-7 Hours Post Allergen Challenge | 15.152 ± 8.834 | 16.275 ± 10.235 |
Collected over From Visit 1a to Visit 17. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Benra 30mg q.4 Week | 0/23 (0%) | 0/23 (0%) | 7/23 (30.4%) |
| Placebo | 0/23 (0%) | 0/23 (0%) | 14/23 (60.9%) |
| Event | Benra 30mg q.4 Week | Placebo |
|---|---|---|
| NasopharyngitisInfections and infestations | 1/23 | 3/23 |
| HeadacheNervous system disorders | 1/23 | 3/23 |
| BronchitisInfections and infestations | 0/23 | 2/23 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 0/23 | 2/23 |
| CyanosisCardiac disorders | 0/23 | 1/23 |
| VomitingGastrointestinal disorders | 0/23 | 1/23 |
| Catheter site haematomaGeneral disorders | 0/23 | 1/23 |
| Injection site painGeneral disorders | 1/23 | 0/23 |
| MalaiseGeneral disorders | 0/23 | 1/23 |
| Vessel puncture site painGeneral disorders | 0/23 | 1/23 |
| Age, Continuous(Years) | Benra 30mg q.4 Week | Placebo | Total |
|---|---|---|---|
| Mean | 30.4 ± 12.3 | 31.5 ± 13.3 | 30.9 ± 12.7 |
| Age, Customized(Participants) | Benra 30mg q.4 Week | Placebo | Total |
|---|---|---|---|
| >=18 - <=50 | 20 | 20 | 40 |
| >50 - <=65 | 3 | 3 | 6 |
| >65 - <=75 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Benra 30mg q.4 Week | Placebo | Total |
|---|---|---|---|
| Female | 14 | 20 | 34 |
| Male | 9 | 3 | 12 |
| Race/Ethnicity, Customized(Participants) | Benra 30mg q.4 Week | Placebo | Total |
|---|---|---|---|
| White | 16 | 19 | 35 |
| Black or African American | 0 | 0 | 0 |
| Asian | 6 | 3 | 9 |
| Other | 1 | 1 | 2 |
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