Efficacy and Safety Study of Benralizumab Added to High-dose Inhaled Corticosteroid Plus LABA in Patients with Uncontrolled Asthma

Study identifier:D3250C00017

ClinicalTrials.gov identifier:NCT01928771

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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

Medical condition

asthma

Phase

Phase 3

Healthy volunteers

Study drug

Sex

All

Actual Enrollment

2681

Study type

Interventional

Age

12 Years - 75 Years

Date

Study Start Date: 19 Sept 2013

Primary Completion Date: 05 Apr 2016

Study Completion Date: 05 Apr 2016

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Mar 2017 by AstraZeneca

Collaborators

Inclusion and exclusion 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

No locations available

Arms	Assigned Interventions
Experimental: Benralizumab 30 mg q.4 weeks Benralizumab administered subcutaneously every 4 weeks	Biological/Vaccine: Benralizumab Benralizumab subcutaneously on study week 0 until study week 44 inclusive.
Experimental: Benralizumab 30 mg q.8 weeks Benralizumab administered subcutaneously every 8 weeks	Biological/Vaccine: Benralizumab Benralizumab subcutaneously on study week 0 until study week 44 inclusive.
Placebo Comparator: Placebo Placebo administered subcutaneously	Biological/Vaccine: Placebo Placebo subcutaneously on study week 0 until study week 44 inclusive. Other Name: Placebo

Documents available

D3250C00017CSP3redacted
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Contact Backup

AstraZeneca Clinical Study Information

+1 800-236-9933