Trial · NCT02821416
Study to Evaluate the Effect of Benralizumab on Allergen-Induced Inflammation in Mild, Atopic Asthmatics
NCT02821416, Phase 3, Completed, AstraZeneca; results first posted 2021-01-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate the Effect of Benralizumab on Allergen-Induced Inflammation in Mild, Atopic Asthmatics. Trials, record NCT02821416. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02821416
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Effect of Benralizumab on Allergen-Induced Inflammation in Mild, Atopic Asthmatics
- NCT number
- NCT02821416
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 46 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Asthma
- Interventions
- Benralizumab, Placebo
- First posted
- 2016-07-01
- Last updated
- 2021-01-07
- Results first posted
- 2021-01-07
- Limitations and caveats
- This allergen challenge study was conducted in a mild, atopic asthma patient population, distinct from the current approved severe eosinophilic asthma indication.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 |
| Primary | 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) |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Percent of Eosinophils in Sputum 7 Hours Post Allergen Challenge | From prechallenge to 7 hours post allergen challenge during week 9 | Primary Efficacy Analysis | Percent | MEAN |
| PRIMARY | 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 | Primary Efficacy Analysis | Percent | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Percent of Eosinophils in Sputum 7 Hours Post Allergen Challenge | Benra 30mg q.4 Weeks | 0.822 | Standard Deviation 4.054 | Percent | |
| Change in Percent of Eosinophils in Sputum 7 Hours Post Allergen Challenge | Placebo | 6.468 | Standard Deviation 9.560 | Percent | |
| Maximal Percentage Decrease in Forced Expiratory Volume in 1 Second 3-7 Hours Post Allergen Challenge | Benra 30mg q.4 Weeks | 15.152 | Standard Deviation 8.834 | Percent | |
| Maximal Percentage Decrease in Forced Expiratory Volume in 1 Second 3-7 Hours Post Allergen Challenge | Placebo | 16.275 | Standard Deviation 10.235 | Percent |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Benra 30mg q.4 Week | 23 | |
| Overall Study | STARTED | Placebo | 23 | |
| Overall Study | COMPLETED | Benra 30mg q.4 Week | 20 | |
| Overall Study | COMPLETED | Placebo | 22 | |
| Overall Study | NOT COMPLETED | Benra 30mg q.4 Week | 3 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events76
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Cyanosis | Cardiac disorders | Benra 30mg q.4 Week | 0 | 23 | 0 |
| other | Cyanosis | Cardiac disorders | Placebo | 1 | 23 | 1 |
| other | Vomiting | Gastrointestinal disorders | Benra 30mg q.4 Week | 0 | 23 | 0 |
| other | Vomiting | Gastrointestinal disorders | Placebo | 1 | 23 | 1 |
| other | Catheter site haematoma | General disorders | Benra 30mg q.4 Week | 0 | 23 | 0 |
| other | Catheter site haematoma | General disorders | Placebo | 1 | 23 | 1 |
| other | Injection site pain | General disorders | Benra 30mg q.4 Week | 1 | 23 | 1 |
| other | Injection site pain | General disorders | Placebo | 0 | 23 | 0 |
| other | Malaise | General disorders | Benra 30mg q.4 Week | 0 | 23 | 0 |
| other | Malaise | General disorders | Placebo | 1 | 23 | 1 |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Benra 30mg q.4 Week | 0 | 23 |
| Total, all-cause mortality | Placebo | 0 | 23 |
| Total, other adverse events | Benra 30mg q.4 Week | 7 | 23 |
| Total, other adverse events | Placebo | 14 | 23 |
| Total, serious adverse events | Benra 30mg q.4 Week | 0 | 23 |
| Total, serious adverse events | Placebo | 0 | 23 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Benra 30mg q.4 Week vs Placebo: deaths from any cause | Trial comparisons |
| Benra 30mg q.4 Week vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02821416
GET https://conductscience.org/api/trials/v1/NCT02821416/events?page=2