Efficacy and Safety Study of Benralizumab Added to Medium-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma
NCT ID: NCT01947946
Last Updated: 2015-11-24
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
13 participants
INTERVENTIONAL
2013-11-30
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Benra 30 mg q.4 Weeks
Fixed 30 mg dose of benralizumab (every 4 weeks)
Benralizumab
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.
Benra 30 mg - Placebo q.8 Weeks
Fixed 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).
Benralizumab
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.
Placebo
A (Dummy) injection
Placebo
Placebo subcutaneously on study week 0 until study week 44 inclusive.
Interventions
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Benralizumab
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.
Placebo
Placebo subcutaneously on study week 0 until study week 44 inclusive.
Eligibility Criteria
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Inclusion Criteria
2. Female and male aged from 18 to 75 years, inclusively
3. 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
4. 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
Exclusion Criteria
2. 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
3. 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
18 Years
75 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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William W. Busse, MD
Role: PRINCIPAL_INVESTIGATOR
Allergy, Pulmonary and Critical Care Medicine, Clinical Science Center 600 Highland Ave, Madison, WI USA
Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Glendale, Arizona, United States
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San Jose, California, United States
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Centennial, Colorado, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Pembroke Pines, Florida, United States
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Winter Park, Florida, United States
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Lawrenceville, Georgia, United States
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Savannah, Georgia, United States
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Bellevue, Nebraska, United States
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Las Vegas, Nevada, United States
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Oklahoma City, Oklahoma, United States
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Pittsburgh, Pennsylvania, United States
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Warwick, Rhode Island, United States
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Rock Hill, South Carolina, United States
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Arlington, Texas, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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San Antonio, Texas, United States
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Sugarland, Texas, United States
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Buenos Aires, , Argentina
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Ciudad de Buenos Aire, , Argentina
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São Paulo, , Brazil
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Rousse, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Hamburg, , Germany
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Mainz, , Germany
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Bydgoszcz, , Poland
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Giżycko, , Poland
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Lodz, , Poland
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Lubin, , Poland
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Ostrów Wielkopolski, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Żnin, , Poland
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Chelyabinsk, , Russia
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Izhevsk, , Russia
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Kazan', , Russia
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Moscow, , Russia
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Novosibirsk, , Russia
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Pyatigorsk, , Russia
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Saint Petersburg, , Russia
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Ulyanovsk, , Russia
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Vladikavkaz, , Russia
Research Site
Yekaterinburg, , Russia
Countries
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Other Identifiers
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D3250C00016
Identifier Type: -
Identifier Source: org_study_id