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

This study is currently recruiting participants.
Verified April 2014 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01947946
First received: September 11, 2013
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Asthma
Biological: Benralizumab
Biological: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Evaluation of the effect of benralizumab on asthma exacerbations in adult patients with uncontrolled asthma [ Time Frame: Immediately following the first administration of study drug through Study Week 48. ] [ Designated as safety issue: No ]
    Annual asthma exacerbation rate (the annual exacerbation rate per patient)


Secondary Outcome Measures:
  • Assessment of the effect of benralizumab on pulmonary function [ Time Frame: Immediately following the first administration of study drug through Study Week 48. ] [ Designated as safety issue: No ]
    Pre-dose/pre-bronchodilator FEV1 (Forced Expiratory Volume in 1 Second) and post-bronchodilator FEV1 at the study centre

  • Assessment of the effect of benralizumab on asthma symptoms [ Time Frame: Immediately following the first administration of study drug through Study Week 48. ] [ Designated as safety issue: No ]
    Asthma symptom score (total, daytime, and night time)

  • Assessment of the effect of benralizumab on emergency room visits and hospitalizations due to asthma [ Time Frame: Immediately following the first administration of study drug through Study Week 48. ] [ Designated as safety issue: No ]
    Annual rate of asthma exacerbations that are associated with an emergency room visit or a hospitalization

  • Evaluation of the pharmacokinetics of benralizumab [ Time Frame: Immediately following the first administration of study drug through Study Week 48. ] [ Designated as safety issue: No ]
    PK (pharmacokinetic) parameters: AUC (area under the plasma concentration-time curve), half-life (t1/2), peak (Cmax) and through (Cmin) plasma concentrations

  • Assessment of the safety and tolerability of benralizumab [ Time Frame: Immediately following the first administration of study drug through Study Week 48. ] [ Designated as safety issue: Yes ]
    - Adverse Events/Serious Adverse Events (AE/SAE) - Laboratory variables - ECG (Electrocardiogram) - Physical Examination

  • Assessment of the effect of benralizumab on other asthma control metrics (as per the ePRO - electronic Patient Reported Outcome) [ Time Frame: Immediately following the first administration of study drug through Study Week 48. ] [ Designated as safety issue: No ]
    - Rescue medication use - Home lung function (morning and evening PEF - Peak Expiratory Flow) - Nights with awakening due to asthma - ACQ-6 - Asthma Control Questionnaire-6)

  • Evaluation of the immunogenicity of benralizumab [ Time Frame: Immediately following the first administration of study drug through Study Week 48. ] [ Designated as safety issue: No ]
    Anti-drug antibodies (ADA)


Estimated Enrollment: 1410
Study Start Date: November 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Benralizumab Arm A
Benralizumab administered subcutaneously
Biological: Benralizumab
Benralizumab subcutaneously on study week 0 until study week 44 inclusive.
Experimental: Benralizumab Arm B
Benralizumab administered subcutaneously
Biological: Benralizumab
Benralizumab subcutaneously on study week 0 until study week 44 inclusive.
Placebo Comparator: Placebo
Placebo administered subcutaneously
Biological: Placebo
Placebo subcutaneously on study week 0 until study week 44 inclusive.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision of informed consent prior to any study specific procedures
  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:

  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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01947946

Contacts
Contact: Clinical Trial Transparency ClinicalTrialTransparency@astrazeneca.com
Contact: AstraZeneca Clinical Study Information +1 800-236-9933 information.center@astrazeneca.com

  Show 161 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: William W. Busse, MD Allergy, Pulmonary and Critical Care Medicine, Clinical Science Center 600 Highland Ave, Madison, WI USA
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01947946     History of Changes
Other Study ID Numbers: D3250C00016
Study First Received: September 11, 2013
Last Updated: April 11, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
United States: Food and Drug Administration
United States: Institutional Review Board
Brazil: Ministry of Health
Mexico: Ministry of Health
Peru: Ministry of Health
Japan: Ministry of Health, Labor and Welfare
Bulgaria: Bulgarian Drug Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
South Africa: Medicines Control Council
Turkey: Ministry of Health
Ukraine: Ministry of Health
Germany: Paul-Ehrlich-Institut
Sweden: Lakemedelsverket Medical Products Agency

Keywords provided by AstraZeneca:
Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive Lung Diseases

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 16, 2014