Trial · NCT02417961
Study to Assess Functionality, Reliability, and Performance of a Pre-filled Syringe With Benralizumab Administered at Home
NCT02417961, Phase 3, Completed, AstraZeneca; results first posted 2017-06-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Assess Functionality, Reliability, and Performance of a Pre-filled Syringe With Benralizumab Administered at Home. Trials, record NCT02417961. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02417961
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess Functionality, Reliability, and Performance of a Pre-filled Syringe With Benralizumab Administered at Home
- NCT number
- NCT02417961
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 162 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Asthma
- Interventions
- Benralizumab
- First posted
- 2015-04-16
- Last updated
- 2018-05-23
- Results first posted
- 2017-06-12
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number and Percentage of Patients/Caregivers Who Successfully Administered Benralizumab 30 mg Subcutaneously (SC) by Injection With an APFS at Home | Week 12, Week 16, and Weeks 12 and 16 | Number (%) of patients/caregivers who successfully administered benralizumab with an APFS at home among those who have been deemed by the Principal Investigator to be suitable for at-home administration and are still in the study. A successful administration is defined as an injection completed, an answer of "Yes" to all 5 questions in the Functioning Device Return Questionnaire for the GREGALE Clinical Study (Appendix to the Clinical Study Protocol), and adequately passed the visual inspection and function tests. The percentage is calculated among all patients/caregivers who had been deemed by the Principal Investigator to be suitable for at home administration and were still in the study at the time point. |
| Primary | Number and Percentage of Returned APFS Used to Administer Benralizumab at Home That Have Been Evaluated as Functional | Week 12, Week 16 | Number (%) of returned APFS used to administer benralizumab at home that have been evaluated as functional among all returned APFS used to administer benralizumab at home. A functional APFS is defined as an answer of "Yes" to all the questions in the visual inspection and function tests. The percentage is calculated among all returned APFS at the specified time point. |
| Primary | Number and Percentage of APFS Used to Administer Benralizumab at Home or in the Clinic and Have Been Reported as Malfunctioning (Product Complaints) | Weeks 0, 4, 8, 12, 16, 0 to 8, 12 to 16, and 0 to 16 | Number (%) of APFS used to administer benralizumab at home or in the clinic and have been reported as malfunctioning (Product Complaints). The percentage is calculated based on APFS dispensed and used for the specified time point. |
| Secondary | The Effect of Benralizumab on Asthma Control Metrics in Terms of Change From Baseline in Mean Asthma Control Questionnaire-6 (ACQ-6) Score | Week 0 (baseline) and weeks 4, 8, 12, 16, 20 | The effect of benralizumab on asthma control metrics in terms of change from baseline in mean Asthma Control Questionnaire-6 (ACQ-6) score. ACQ-6 score is defined as the average of the first 6 items of the ACQ questionnaire on symptoms, activity limitations, and rescue medication. Baseline is defined as the last non-missing observation prior to the first dose of study treatment. ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Smaller score indicates better controlled asthma. |
| Secondary | The Pharmacokinetics (PK) of Benralizumab in the Terms of PK Parameters: Serum Concentration of Benralizumab | Baseline, Week 8, Week 20, and Week 28 | Mean PK Concentration at each visit |
| Secondary | The Pharmacodynamics of Benralizumab in the Terms of Peripheral Blood Eosinophil Levels | Baseline, Week 20, and Week 28 | Blood eosinophil counts by timepoint |
| Secondary | The Immunogenicity of Benralizumab in the Terms of Anti-drug Antibodies (ADA) | Baseline until Week 28 | Anti-drug antibodies (ADA) responses at baseline and post baseline. Persistently positive is defined as positive at \>=2 post-baseline assessments (with \>=16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive is defined as having at least one post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number and Percentage of Patients/Caregivers Who Successfully Administered Benralizumab 30 mg Subcutaneously (SC) by Injection With an APFS at Home | Week 12, Week 16, and Weeks 12 and 16 | Full analysis set - all patients who were administered for at least one dose of Benralizumab. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number and Percentage of Returned APFS Used to Administer Benralizumab at Home That Have Been Evaluated as Functional | Week 12, Week 16 | Full analysis set - all patients who were administered for at least one dose of Benralizumab. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number and Percentage of APFS Used to Administer Benralizumab at Home or in the Clinic and Have Been Reported as Malfunctioning (Product Complaints) | Weeks 0, 4, 8, 12, 16, 0 to 8, 12 to 16, and 0 to 16 | Number of Units analyzed per row represents number of accessorized pre-filled syringes used at each time point. | Accessorized Pre-filled Syringe | COUNT_OF_UNITS |
| SECONDARY | The Effect of Benralizumab on Asthma Control Metrics in Terms of Change From Baseline in Mean Asthma Control Questionnaire-6 (ACQ-6) Score | Week 0 (baseline) and weeks 4, 8, 12, 16, 20 | Full analysis set - all patients who were administered for at least one dose of Benralizumab. | Scores on a scale | MEAN |
| SECONDARY | The Pharmacokinetics (PK) of Benralizumab in the Terms of PK Parameters: Serum Concentration of Benralizumab | Baseline, Week 8, Week 20, and Week 28 | PK analysis set - include all patients who had at least one quantifiable serum PK observation post first dose of Benralizumab. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | The Pharmacodynamics of Benralizumab in the Terms of Peripheral Blood Eosinophil Levels | Baseline, Week 20, and Week 28 | Full analysis set - all patients who were administered for at least one dose of Benralizumab. | cells/ uL | MEAN |
| SECONDARY | The Immunogenicity of Benralizumab in the Terms of Anti-drug Antibodies (ADA) | Baseline until Week 28 | Full analysis set - all patients who were administered for at least one dose of Benralizumab. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group31
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number and Percentage of Patients/Caregivers Who Successfully Administered Benralizumab 30 mg Subcutaneously (SC) by Injection With an APFS at Home | Benra 30 mg | Week 12 | 112 | Participants | |
| Number and Percentage of Patients/Caregivers Who Successfully Administered Benralizumab 30 mg Subcutaneously (SC) by Injection With an APFS at Home | Benra 30 mg | Week 16 | 108 | Participants | |
| Number and Percentage of Patients/Caregivers Who Successfully Administered Benralizumab 30 mg Subcutaneously (SC) by Injection With an APFS at Home | Benra 30 mg | Weeks 12 and 16 | 106 | Participants | |
| Number and Percentage of Returned APFS Used to Administer Benralizumab at Home That Have Been Evaluated as Functional | Benra 30 mg | Week 12 | 113 | Participants | |
| Number and Percentage of Returned APFS Used to Administer Benralizumab at Home That Have Been Evaluated as Functional | Benra 30 mg | Week 16 | 108 | Participants | |
| Number and Percentage of APFS Used to Administer Benralizumab at Home or in the Clinic and Have Been Reported as Malfunctioning (Product Complaints) | Benra 30 mg | Week 0 | 0 | Accessorized Pre-filled Syringe | |
| Number and Percentage of APFS Used to Administer Benralizumab at Home or in the Clinic and Have Been Reported as Malfunctioning (Product Complaints) | Benra 30 mg | Week 4 | 1 | Accessorized Pre-filled Syringe | |
| Number and Percentage of APFS Used to Administer Benralizumab at Home or in the Clinic and Have Been Reported as Malfunctioning (Product Complaints) | Benra 30 mg | Week 8 | 0 | Accessorized Pre-filled Syringe | |
| Number and Percentage of APFS Used to Administer Benralizumab at Home or in the Clinic and Have Been Reported as Malfunctioning (Product Complaints) | Benra 30 mg | Week 12 | 0 | Accessorized Pre-filled Syringe | |
| Number and Percentage of APFS Used to Administer Benralizumab at Home or in the Clinic and Have Been Reported as Malfunctioning (Product Complaints) | Benra 30 mg | Week 16 | 0 | Accessorized Pre-filled Syringe |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Benra 30 mg | 116 | |
| Overall Study | COMPLETED | Benra 30 mg | 112 | |
| Overall Study | NOT COMPLETED | Benra 30 mg | 4 |
Source ClinicalTrials.gov
Adverse events15
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 | Bronchitis | Infections and infestations | Benra 30 mg | 4 | 116 | 4 |
| other | Nasopharyngitis | Infections and infestations | Benra 30 mg | 16 | 116 | 19 |
| other | Sinusitis | Infections and infestations | Benra 30 mg | 6 | 116 | 7 |
| other | Upper respiratory tract infection | Infections and infestations | Benra 30 mg | 13 | 116 | 14 |
| other | Viral upper respiratory tract infection | Infections and infestations | Benra 30 mg | 5 | 116 | 5 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Benra 30 mg | 4 | 116 | 4 |
| other | Headache | Nervous system disorders | Benra 30 mg | 6 | 116 | 10 |
| serious | Colitis | Gastrointestinal disorders | Benra 30 mg | 1 | 116 | 1 |
| serious | Large intestine polyp | Gastrointestinal disorders | Benra 30 mg | 1 | 116 | 1 |
| serious | Non-cardiac chest pain | General disorders | Benra 30 mg | 1 | 116 | 1 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Benra 30 mg | 0 | 116 |
| Total, other adverse events | Benra 30 mg | 43 | 116 |
| Total, serious adverse events | Benra 30 mg | 7 | 116 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29670379 | BACKGROUND |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02417961
GET https://conductscience.org/api/trials/v1/NCT02417961/results?page=2