Efficacy and Safety Study of Benralizumab in Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01914757 |
Recruitment Status :
Completed
First Posted : August 2, 2013
Results First Posted : January 25, 2017
Last Update Posted : January 25, 2017
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Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment |
Condition |
Asthma |
Interventions |
Biological: Benralizumab Biological: Placebo |
Enrollment | 2508 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | 2505 participants signed informed consent, 2181 entered screening/run-in period, 1306 participants were randomised to receive treatment with benralizumab 30 mg Q4W, Q8W, or placebo. Of the 1306 patients randomised, all (100.0%) received treatment with study drug. |
Arm/Group Title | Benralizumab 30 mg q.4 Weeks | Benralizumab 30 mg q.8 Weeks | Placebo |
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Benralizumab administered subcutaneously every 4 weeks | Benralizumab administered subcutaneously every 8 weeks | Placebo administered subcutaneously |
Period Title: Overall Study | |||
Started | 425 | 441 | 440 |
Completed | 389 | 390 | 402 |
Not Completed | 36 | 51 | 38 |
Reason Not Completed | |||
Severe non-compliance to protocol | 3 | 1 | 2 |
Lost to Follow-up | 5 | 8 | 6 |
Withdrawal by Subject | 15 | 27 | 19 |
Death | 2 | 2 | 1 |
Adverse Event | 4 | 3 | 4 |
Study specific withdrawal criteria | 0 | 1 | 0 |
Eligibility criteria not fulfilled | 2 | 0 | 2 |
Other reasons | 5 | 9 | 4 |
Baseline Characteristics
Arm/Group Title | Benralizumab 30 mg q.4 Weeks | Benralizumab 30 mg q.8 Weeks | Placebo | Total | |
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Benralizumab administered subcutaneously every 4 weeks | Benralizumab administered subcutaneously every 8 weeks | Placebo administered subcutaneously | Total of all reporting groups | |
Overall Number of Baseline Participants | 425 | 441 | 440 | 1306 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 425 participants | 441 participants | 440 participants | 1306 participants | |
50.0 (13.6) | 49 (14.3) | 48.8 (15.1) | 49.2 (14.3) | ||
Gender
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 425 participants | 441 participants | 440 participants | 1306 participants | |
Female |
270 63.5%
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273 61.9%
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264 60.0%
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807 61.8%
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Male |
155 36.5%
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168 38.1%
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176 40.0%
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499 38.2%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
≥ 60 days prior to submission of material for publication/presentation, Institution and PI shall jointly provide AZ with material for review. No publication/presentation may include any of AZ's Confidential Information without AZ's written approval. AZ can request Inst. and PI to withhold material from submission for publication/presentation for an additional 90 days to allow AZ to establish and preserve its proprietary rights in the material being submitted for publication or presentation.
Results Point of Contact
Name/Title: | Mitchell Goldman, Medical Science Director |
Organization: | AstraZeneca |
Phone: | +1 301 398 0323 |
EMail: | Mitchell.Goldman@astrazeneca.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT01914757 |
Other Study ID Numbers: |
D3250C00018 |
First Submitted: | July 31, 2013 |
First Posted: | August 2, 2013 |
Results First Submitted: | September 8, 2016 |
Results First Posted: | January 25, 2017 |
Last Update Posted: | January 25, 2017 |