Clinical trial NCT01928771: Efficacy and Safety Study of Benralizumab Added to High-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma
Official title: A Multicentre, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase III Efficacy and Safety Study of Benralizumab (MEDI-563) Added to High-dose Inhaled Corticosteroid Plus Long-acting β2 Agonist in Patients With Uncontrolled Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma,
Bronchial Diseases,
Respiratory Tract Diseases,
Lung Diseases,
Obstructive Lung Diseases
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2013-08-27
Enrollment: 2681
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Benralizumab reduces the number of asthma exacerbations in patients who remain uncontrolled on high doses of ICS-LABA.


Eligibility criteria: Inclusion Criteria:

1. Written informed consent for study participation must be obtained prior to any study related procedures being performed (local regulations are to be followed in determining the assent/consent requirements for children and parent\[s\]/guardian\[s\]) and according to international guidelines and/or applicable European Union guidelines.
2. Female and Male aged 12 to 75 years inclusively, at the time of visit 1. For those patients, who are 17 on the day of Visit 1 but will turn 18 after this day, will be considered an adolescent for the purposes of this trial.
3. History of physician-diagnosed asthma requiring treatment with medium-to-high dose ICS (\>250μg fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit 1
4. Documented treatment with ICS and LABA for at least 3 months prior to Visit 1 with or without oral corticosteroids and additional asthma controllers.

   * For subjects 18 years of age and older, the ICS dose must be \>500 mcg/day fluticasone propionate dry powder formulation or equivalent daily.
   * For subjects ages 12-17, the ICS dose must be ≥500 mcg /day fluticasone propionate dry powder formulation or equivalent daily.

Exclusion criteria:

1. 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)
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

Primary outcomes:
measure: Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils >=300/uL
timeFrame: Immediately following the first administration of study drug through Study Week 48.
Secondary outcomes:
measure: Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils < 300/uL
timeFrame: Immediately following the first administration of study drug through Study Week 48.
measure: Annual Asthma Exacerbation Rate Resulting Emergency Room Visits and Hospitalizations
timeFrame: Immediately following the first administration of study drug through Study Week 48.
measure: Number of Patients With >=1 Asthma Exacerbations
timeFrame: Immediately following the first administration of study drug through Study Week 48.
measure: Time to First Asthma Exacerbation
timeFrame: Immediately following the first administration of study drug through Study Week 48.
measure: Mean Change From Baseline to Week 48 in Pre-bronchodilator FEV1 (L) Value for Baseline Eosinophils >=300/uL
timeFrame: Immediately following the first administration of study drug through Study Week 48.
measure: Mean Change From Baseline to Week 48 in Pre-bronchodilator FEV1 (L) Value for Baseline Eosinophils <300/uL
timeFrame: Immediately following the first administration of study drug through Study Week 48.
measure: Mean Change From Baseline to Week 48 in Asthma Symptom Score for Baseline Eosinophils >=300/uL
timeFrame: Immediately following the first administration of study drug through Study Week 48.
measure: Mean Change From Baseline to Week 48 in Asthma Symptom Score for Baseline Eosinophils <300/uL
timeFrame: Immediately following the first administration of study drug through Study Week 48.
measure: Change in Asthma Rescue Medication
timeFrame: Immediately following the first administration of study drug through Study Week 48.
measure: Home Lung Function Assessment Based on Morning PEF
timeFrame: Immediately following the first administration of study drug through Study Week 48.
measure: Home Lung Function Assessment Based on Evening PEF
timeFrame: Immediately following the first administration of study drug through Study Week 48.
measure: Proportion of Night Awakening Due to Asthma
timeFrame: Immediately following the first administration of study drug through Study Week 48.
measure: Mean Change From Baseline to Week 48 in ACQ-6 for Baseline Eosinophils >=300/uL
timeFrame: Immediately following the first administration of study drug through Study Week 48.
measure: Mean Change From Baseline to Week 48 in ACQ-6 for Baseline Eosinophils <300/uL
timeFrame: Immediately following the first administration of study drug through Study Week 48.
measure: Pharmacokinetics of Benralizumab
timeFrame: Baseline, week 4, week 4 day 6, week 8, week 16, week 24, week 32, week 40, week 48, week 56
measure: Immunogenicity of Benralizumab
timeFrame: Pre-treatment until end of follow-up
measure: Extend of Exposure
timeFrame: Immediately following the first administration of study drug through Study Week 48.
measure: Mean Change From Baseline to Week 48 in AQLQ(S)+12
timeFrame: Immediately following the first administration of study drug through Study Week 48.
measure: Mean Change From Baseline to Week 48 in EQ-5D-5L VAS
timeFrame: Immediately following the first administration of study drug through Study Week 48.
measure: Mean Work Productivity Loss Due to Asthma
timeFrame: Immediately following the first administration of study drug through Study Week 48.
measure: Mean Productivity Loss Due to Asthma in Classroom
timeFrame: Immediately following the first administration of study drug through Study Week 48.
measure: Number of Participants That Utilized Health Care Resources
timeFrame: Immediately following the first administration of study drug through Study Week 48.
measure: Patient and Clinician's Responder Assessment to Treatment
timeFrame: Immediately following the first administration of study drug through Study Week 48
Other outcomes:
Locations:
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city: Mt Pleasant
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city: Chattanooga
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city: Germantown
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state: Wisconsin
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country: Brazil
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country: Brazil
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country: Brazil
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country: Bulgaria
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country: Bulgaria
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country: Bulgaria
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country: Bulgaria
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country: Bulgaria
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country: Czech Republic
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city: Jindrichuv Hradec
country: Czech Republic
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country: Czech Republic
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country: France
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country: France
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country: France
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country: France
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country: France
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country: France
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country: France
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country: France
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country: France
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country: France
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city: Bari
country: Italy
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country: Italy
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country: Italy
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country: Italy
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country: Italy
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country: Italy
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country: Italy
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country: Italy
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country: Italy
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country: Italy
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country: Italy
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country: Italy
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country: Italy
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country: Italy
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country: Italy
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country: Italy
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country: Italy
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country: Korea, Republic of
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country: Korea, Republic of
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country: Korea, Republic of
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country: Korea, Republic of
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country: Korea, Republic of
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country: Korea, Republic of
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country: Korea, Republic of
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country: Korea, Republic of
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country: Korea, Republic of
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country: Mexico
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country: Mexico
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country: Mexico
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country: Peru
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country: Poland
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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city: Benoni
country: South Africa
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country: South Africa
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country: South Africa
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city: Mowbray
country: South Africa
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city: Stanger
country: South Africa
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city: Barcelona
country: Spain
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city: Lugo
country: Spain
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city: Madrid
country: Spain
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city: Málaga
country: Spain
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city: Oviedo
country: Spain
facility: Research Site
city: Palma de Mallorca
country: Spain
facility: Research Site
city: Sagunto(Valencia)
country: Spain
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city: Salamanca
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Adana
country: Turkey
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city: Ankara
country: Turkey
facility: Research Site
city: Antalya
country: Turkey
facility: Research Site
city: Bursa
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Izmir
country: Turkey
facility: Research Site
city: Kocaeli
country: Turkey
facility: Research Site
city: Mersin
country: Turkey
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Bradford
country: United Kingdom
facility: Research Site
city: Cambridge
country: United Kingdom
facility: Research Site
city: Chertsey
country: United Kingdom
facility: Research Site
city: Chester
country: United Kingdom
facility: Research Site
city: Chippenham
country: United Kingdom
facility: Research Site
city: Cottingham
country: United Kingdom
facility: Research Site
city: Darlington
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: High Heaton/Newcastle upon Tyn
country: United Kingdom
facility: Research Site
city: Leeds
country: United Kingdom
facility: Research Site
city: Liverpool
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Maidstone
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Nottingham
country: United Kingdom
facility: Research Site
city: Plymouth
country: United Kingdom
facility: Research Site
city: Portsmouth
country: United Kingdom
facility: Research Site
city: Soham
country: United Kingdom
facility: Research Site
city: Somerset
country: United Kingdom
facility: Research Site
city: Stevenage
country: United Kingdom
facility: Research Site
city: Stockton
country: United Kingdom
facility: Research Site
city: Hanoi
country: Vietnam
facility: Research Site
city: Ho Chi Minh
country: Vietnam
facility: Research Site
Study officials:
affiliation: Center for Genomics and Personalized Medicine Research, Medical Center Boulevard, Winston-Salem, North Carolina 27157
name: Eugene R. Bleecker, MD, Professor of Medicine
role: PRINCIPAL_INVESTIGATOR
References:
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