Trial · NCT02808819
A Safety Extension Study With Benralizumab for Asthmatic Adults on Inhaled Corticosteroid Plus Long-acting β2 Agonist
NCT02808819, Phase 3, Completed, AstraZeneca; results first posted 2021-04-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Safety Extension Study With Benralizumab for Asthmatic Adults on Inhaled Corticosteroid Plus Long-acting β2 Agonist. Trials, record NCT02808819. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02808819
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety Extension Study With Benralizumab for Asthmatic Adults on Inhaled Corticosteroid Plus Long-acting β2 Agonist
- NCT number
- NCT02808819
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 447 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Asthma
- Interventions
- Benralizumab, Benralizumab
- First posted
- 2016-06-22
- Last updated
- 2021-04-13
- Results first posted
- 2021-04-13
- Limitations and caveats
All participants in this study had to complete treatment in predecessor studies. Therefore selection bias may exist. Baseline is defined for this study's entry value, not the value prior to Benralizumab treatment. All participants have been treated with Benralizumab prior to this study's entry.
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Basophils, Full Analysis Set | From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented. | Change from baseline in hematologic lab parameter of Basophils. |
| Primary | Change From Baseline in Leukocytes, Full Analysis Set | From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented. | Change from baseline in hematologic lab parameter of Leukocytes. |
| Primary | Change From Baseline in Lymphocytes, Full Analysis Set | From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented. | Change from baseline in hematologic lab parameter of Lymphocytes. |
| Primary | Change From Baseline in Neutrophils, Full Analysis Set | From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented. | Change from baseline in hematologic lab parameter of Neutrophils. |
| Primary | Change From Baseline in Monocytes, Full Analysis Set | From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented. | Change from baseline in hematologic lab parameter of Monocytes. |
| Primary | Change From Baseline in Platelets, Full Analysis Set | From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented. | Change from baseline in hematologic lab parameter of Platelets. |
| Primary | Change From Baseline in Hematocrit, Full Analysis Set | From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented. | Change from baseline in hematologic lab parameter of Hematocrit. |
| Primary | Change From Baseline in Erythrocytes, Full Analysis Set | From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented. | Change from baseline in hematologic lab parameter of Erythrocytes. |
| Primary | Change From Baseline in Hemoglobin, Full Analysis Set | From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented. | Change from baseline in hematologic lab parameter of Hemoglobin. |
| Primary | Change From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set | From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented. | Change from baseline in chemistry test ALT. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Basophils, Full Analysis Set | From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented. | Full analysis set. For each lab test, number of patients is the number of patients with available change from baseline value. | 10^9 cells/L | MEAN |
| PRIMARY | Change From Baseline in Leukocytes, Full Analysis Set | From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented. | Full analysis set. For each lab test, number of patients is the number of patients with available change from baseline value. | 10^9 cells/L | MEAN |
| PRIMARY | Change From Baseline in Lymphocytes, Full Analysis Set | From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented. | Full analysis set. For each lab test, number of patients is the number of patients with available change from baseline value. | 10^9 cells/L | MEAN |
| PRIMARY | Change From Baseline in Neutrophils, Full Analysis Set | From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented. | Full analysis set. For each lab test, number of patients is the number of patients with available change from baseline value. | 10^9 cells/L | MEAN |
| PRIMARY | Change From Baseline in Monocytes, Full Analysis Set | From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented. | Full analysis set. For each lab test, number of patients is the number of patients with available change from baseline value. | 10^9 cells/L | MEAN |
| PRIMARY | Change From Baseline in Platelets, Full Analysis Set | From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented. | Full analysis set. For each lab test, number of patients is the number of patients with available change from baseline value. | 10^9 cells/L | MEAN |
| PRIMARY | Change From Baseline in Hematocrit, Full Analysis Set | From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented. | Full analysis set. For each lab test, number of patients is the number of patients with available change from baseline value. | [ratio] | MEAN |
| PRIMARY | Change From Baseline in Erythrocytes, Full Analysis Set | From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented. | Full analysis set. For each lab test, number of patients is the number of patients with available change from baseline value. | 10^12 cells/L | MEAN |
| PRIMARY | Change From Baseline in Hemoglobin, Full Analysis Set | From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented. | Full analysis set. For each lab test, number of patients is the number of patients with available change from baseline value. | g/L | MEAN |
| PRIMARY | Change From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set | From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented. | Full analysis set. For each lab test, number of patients is the number of patients with available change from baseline value. | ukat/L | MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group72
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Basophils, Full Analysis Set | Benra 30 mg q.4 Weeks | 0.014 | Standard Deviation 0.0229 | 10^9 cells/L | |
| Change From Baseline in Basophils, Full Analysis Set | Benra 30 mg q.8 Weeks | 0.012 | Standard Deviation 0.0243 | 10^9 cells/L | |
| Change From Baseline in Basophils, Full Analysis Set | Total | 0.013 | Standard Deviation 0.0236 | 10^9 cells/L | |
| Change From Baseline in Leukocytes, Full Analysis Set | Benra 30 mg q.4 Weeks | -0.254 | Standard Deviation 2.0446 | 10^9 cells/L | |
| Change From Baseline in Leukocytes, Full Analysis Set | Benra 30 mg q.8 Weeks | -0.498 | Standard Deviation 1.7217 | 10^9 cells/L | |
| Change From Baseline in Leukocytes, Full Analysis Set | Total | -0.377 | Standard Deviation 1.8896 | 10^9 cells/L | |
| Change From Baseline in Lymphocytes, Full Analysis Set | Benra 30 mg q.4 Weeks | -0.098 | Standard Deviation 0.5479 | 10^9 cells/L | |
| Change From Baseline in Lymphocytes, Full Analysis Set | Benra 30 mg q.8 Weeks | -0.142 | Standard Deviation 0.6544 | 10^9 cells/L | |
| Change From Baseline in Lymphocytes, Full Analysis Set | Total | -0.121 | Standard Deviation 0.6038 | 10^9 cells/L | |
| Change From Baseline in Neutrophils, Full Analysis Set | Benra 30 mg q.4 Weeks | -0.237 | Standard Deviation 1.8765 | 10^9 cells/L |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Benra 30 mg q.4 Weeks | 220 | |
| Overall Study | STARTED | Benra 30 mg q.8 Weeks | 226 | |
| Overall Study | Treated | Benra 30 mg q.4 Weeks | 220 | |
| Overall Study | Treated | Benra 30 mg q.8 Weeks | 226 | |
| Overall Study | COMPLETED | Benra 30 mg q.4 Weeks | 189 | |
| Overall Study | COMPLETED | Benra 30 mg q.8 Weeks | 195 | |
| Overall Study | NOT COMPLETED | Benra 30 mg q.4 Weeks | 31 | |
| Overall Study | NOT COMPLETED | Benra 30 mg q.8 Weeks | 31 |
Source ClinicalTrials.gov
Adverse events226
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 | Diarrhoea | Gastrointestinal disorders | Benra 30 mg q.4 Weeks | 8 | 220 | 12 |
| other | Diarrhoea | Gastrointestinal disorders | Benra 30 mg q.8 Weeks | 6 | 226 | 6 |
| other | Influenza like illness | General disorders | Benra 30 mg q.4 Weeks | 7 | 220 | 9 |
| other | Influenza like illness | General disorders | Benra 30 mg q.8 Weeks | 8 | 226 | 10 |
| other | Acute sinusitis | Infections and infestations | Benra 30 mg q.4 Weeks | 13 | 220 | 20 |
| other | Acute sinusitis | Infections and infestations | Benra 30 mg q.8 Weeks | 8 | 226 | 10 |
| other | Bronchitis | Infections and infestations | Benra 30 mg q.4 Weeks | 23 | 220 | 33 |
| other | Bronchitis | Infections and infestations | Benra 30 mg q.8 Weeks | 22 | 226 | 26 |
| other | Bronchitis bacterial | Infections and infestations | Benra 30 mg q.4 Weeks | 12 | 220 | 17 |
| other | Bronchitis bacterial | Infections and infestations | Benra 30 mg q.8 Weeks | 9 | 226 | 13 |
1 to 10 of 226Source ClinicalTrials.gov
See all 226 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Benra 30 mg q.4 Weeks | 1 | 220 |
| Total, all-cause mortality | Benra 30 mg q.8 Weeks | 0 | 226 |
| Total, other adverse events | Benra 30 mg q.4 Weeks | 169 | 220 |
| Total, other adverse events | Benra 30 mg q.8 Weeks | 145 | 226 |
| Total, serious adverse events | Benra 30 mg q.4 Weeks | 44 | 220 |
| Total, serious adverse events | Benra 30 mg q.8 Weeks | 47 | 226 |
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 30 mg q.4 Weeks vs Benra 30 mg q.8 Weeks: deaths from any cause | Trial comparisons |
| Benra 30 mg q.4 Weeks vs Benra 30 mg q.8 Weeks: 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/NCT02808819
GET https://conductscience.org/api/trials/v1/NCT02808819/results?page=2