Skip to main content
MedPathMedPath Home
Clinical Trials/NCT01928771
NCT01928771
Completed
Phase 3

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

AstraZeneca1 site in 1 country2,681 target enrollmentStarted: September 19, 2013Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsAsthma

Overview

Phase
Phase 3
Status
Completed
Enrollment
2,681
Locations
1
Primary Endpoint
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils >=300/uL
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
12 Years to 75 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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.
  • •Female and Male aged 12 to 75 years inclusively, at the time of visit
  • •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.
  • •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
  • •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:
  • •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:

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils >=300/uL

Time Frame: Immediately following the first administration of study drug through Study Week 48.

The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF

Secondary Outcomes

  • Time to First Asthma Exacerbation(Immediately following the first administration of study drug through Study Week 48.)
  • Mean Change From Baseline to Week 48 in Pre-bronchodilator FEV1 (L) Value for Baseline Eosinophils <300/uL(Immediately following the first administration of study drug through Study Week 48.)
  • Mean Change From Baseline to Week 48 in Asthma Symptom Score for Baseline Eosinophils <300/uL(Immediately following the first administration of study drug through Study Week 48.)
  • Proportion of Night Awakening Due to Asthma(Immediately following the first administration of study drug through Study Week 48.)
  • Mean Change From Baseline to Week 48 in ACQ-6 for Baseline Eosinophils >=300/uL(Immediately following the first administration of study drug through Study Week 48.)
  • Mean Change From Baseline to Week 48 in Asthma Symptom Score for Baseline Eosinophils >=300/uL(Immediately following the first administration of study drug through Study Week 48.)
  • Immunogenicity of Benralizumab(Pre-treatment until end of follow-up)
  • Number of Patients With >=1 Asthma Exacerbations(Immediately following the first administration of study drug through Study Week 48.)
  • Change in Asthma Rescue Medication(Immediately following the first administration of study drug through Study Week 48.)
  • Home Lung Function Assessment Based on Morning PEF(Immediately following the first administration of study drug through Study Week 48.)
  • Mean Change From Baseline to Week 48 in ACQ-6 for Baseline Eosinophils <300/uL(Immediately following the first administration of study drug through Study Week 48.)
  • Number of Participants That Utilized Health Care Resources(Immediately following the first administration of study drug through Study Week 48.)
  • Annual Asthma Exacerbation Rate Resulting Emergency Room Visits and Hospitalizations(Immediately following the first administration of study drug through Study Week 48.)
  • Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils < 300/uL(Immediately following the first administration of study drug through Study Week 48.)
  • Mean Change From Baseline to Week 48 in Pre-bronchodilator FEV1 (L) Value for Baseline Eosinophils >=300/uL(Immediately following the first administration of study drug through Study Week 48.)
  • Home Lung Function Assessment Based on Evening PEF(Immediately following the first administration of study drug through Study Week 48.)
  • Mean Change From Baseline to Week 48 in AQLQ(S)+12(Immediately following the first administration of study drug through Study Week 48.)
  • Pharmacokinetics of Benralizumab(Baseline, week 4, week 4 day 6, week 8, week 16, week 24, week 32, week 40, week 48, week 56)
  • Mean Change From Baseline to Week 48 in EQ-5D-5L VAS(Immediately following the first administration of study drug through Study Week 48.)
  • Mean Work Productivity Loss Due to Asthma(Immediately following the first administration of study drug through Study Week 48.)
  • Patient and Clinician's Responder Assessment to Treatment(Immediately following the first administration of study drug through Study Week 48)
  • Extend of Exposure(Immediately following the first administration of study drug through Study Week 48.)
  • Mean Productivity Loss Due to Asthma in Classroom(Immediately following the first administration of study drug through Study Week 48.)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Terminated
Phase 3
Efficacy and Safety Study of Benralizumab Added to Medium-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled AsthmaAsthma
NCT01947946AstraZeneca13
Completed
Phase 3
A Study of the Safety and Effectiveness of Benralizumab to Treat Patients With Severe Uncontrolled Asthma.Asthma
NCT03170271AstraZeneca660
Completed
Phase 3
Efficacy and Safety Study of Benralizumab in Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 AgonistAsthma
NCT01914757AstraZeneca2,508
Terminated
Phase 2
Efficacy and Safety of QGE031 Compared With Placebo in Patients Aged 18-75 Years With AsthmaAsthma
NCT02336425Novartis Pharmaceuticals10
Completed
Phase 4
GSK BHR Study (Sont)Asthma
NCT00920543GlaxoSmithKline464