Study Stopped
Study terminated due to sponsor decision
Efficacy and Safety Study of Benralizumab Added to Medium-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma
A Multicentre, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase III Efficacy and Safety Study of Benralizumab (MEDI-563) Added to Medium-dose Inhaled Corticosteroid Plus Long-acting β2 Agonist in Patients With Uncontrolled Asthma
1 other identifier
interventional
13
7 countries
47
Brief Summary
The purpose of this study is to determine whether Benralizumab reduces the number of asthma exacerbations in patients who remain uncontrolled on medium doses of ICS-LABA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 asthma
Started Nov 2013
Shorter than P25 for phase_3 asthma
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2013
CompletedFirst Posted
Study publicly available on registry
September 23, 2013
CompletedStudy Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedResults Posted
Study results publicly available
November 23, 2015
CompletedNovember 24, 2015
October 1, 2015
8 months
September 11, 2013
July 21, 2015
November 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Asthma Exacerbations Over 48 Weeks Treatment
The number of asthma exacerbations over 48 weeks treatment will be counted
48 weeks treatment
Study Arms (3)
Benra 30 mg q.4 Weeks
EXPERIMENTALFixed 30 mg dose of benralizumab (every 4 weeks)
Benra 30 mg - Placebo q.8 Weeks
EXPERIMENTALFixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administered at the 4 week interim treatment visits to maintain blind).
Placebo
PLACEBO COMPARATORA (Dummy) injection
Interventions
Benra 30 mg q.4 Weeks is a fixed 30 mg dose of benralizumab subcutaneously on study week 0 until study week 44 inclusive. Benra 30 mg - Placebo q.8 Weeks is a fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administrated at the 4 week interim visits to maintain blind). It is subcutaneously administered on study week 0 until study week 44 inclusive.
Eligibility Criteria
You may qualify if:
- Provision of informed consent prior to any study specific procedures
- Female and male aged from 18 to 75 years, inclusively
- History of physician-diagnosed asthma requiring treatment with medium dose ICS (\>250ug fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit 1
- Documented treatment with medium-dose ICS (\>250ug and ≤500ug fluticasone dry powder formulation equivalents total daily dose) and LABA for at least 3 month prior to Visit 1
You may not qualify if:
- Clinically important pulmonary disease other than asthma (e.g. active lung infection, COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis, Churg- Strauss syndrome, hypereosinophilic syndrome)
- Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could: - Affect the safety of the patient throughout the study - Influence the findings of the studies or their interpretations - Impede the patient's ability to complete the entire duration of study
- Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period 4. Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis during screening/run-in period, which in the opinion of the Investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient's ability to complete entire duration of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (47)
Research Site
Birmingham, Alabama, United States
Research Site
Glendale, Arizona, United States
Research Site
San Jose, California, United States
Research Site
Centennial, Colorado, United States
Research Site
Miami, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Pembroke Pines, Florida, United States
Research Site
Winter Park, Florida, United States
Research Site
Lawrenceville, Georgia, United States
Research Site
Savannah, Georgia, United States
Research Site
Bellevue, Nebraska, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Warwick, Rhode Island, United States
Research Site
Rock Hill, South Carolina, United States
Research Site
Arlington, Texas, United States
Research Site
Austin, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Sugarland, Texas, United States
Research Site
Buenos Aires, Argentina
Research Site
Ciudad de Buenos Aire, Argentina
Research Site
São Paulo, Brazil
Research Site
Rousse, Bulgaria
Research Site
Sofia, Bulgaria
Research Site
Varna, Bulgaria
Research Site
Hamburg, Germany
Research Site
Mainz, Germany
Research Site
Bydgoszcz, Poland
Research Site
Giżycko, Poland
Research Site
Lodz, Poland
Research Site
Lubin, Poland
Research Site
Ostrów Wielkopolski, Poland
Research Site
Warsaw, Poland
Research Site
Wroclaw, Poland
Research Site
Żnin, Poland
Research Site
Chelyabinsk, Russia
Research Site
Izhevsk, Russia
Research Site
Kazan', Russia
Research Site
Moscow, Russia
Research Site
Novosibirsk, Russia
Research Site
Pyatigorsk, Russia
Research Site
Saint Petersburg, Russia
Research Site
Ulyanovsk, Russia
Research Site
Vladikavkaz, Russia
Research Site
Yekaterinburg, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Steven Fox
- Organization
- AZ-PPD
Study Officials
- PRINCIPAL INVESTIGATOR
William W. Busse, MD
Allergy, Pulmonary and Critical Care Medicine, Clinical Science Center 600 Highland Ave, Madison, WI USA
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2013
First Posted
September 23, 2013
Study Start
November 1, 2013
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
November 24, 2015
Results First Posted
November 23, 2015
Record last verified: 2015-10