Phase 3
Completed N=46
Study to Evaluate the Effect of Benralizumab on Allergen-Induced Inflammation in Mild, Atopic Asthmatics
Source: ClinicalTrials.gov NCT02821416 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcomePrimary: Change in Percent of Eosinophils in Sputum 7 Hours Post Allergen Challenge — 0.822; 6.468 Percent — p=0.0208
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Percent of Eosinophils in Sputum 7 Hours Post Allergen Challenge |
0.822; 6.468 | 0.0208 sig |
| PRIMARY Maximal Percentage Decrease in Forced Expiratory Volume in 1 Second 3-7 Hours Post Allergen Challenge |
15.152; 16.275 | 0.3630 |
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
Data sourced from ClinicalTrials.gov (NCT02821416). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.