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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01947946
Recruitment Status : Terminated (Study terminated due to sponsor decision)
First Posted : September 23, 2013
Results First Posted : November 23, 2015
Last Update Posted : November 24, 2015
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE September 11, 2013
First Posted Date  ICMJE September 23, 2013
Results First Submitted Date  ICMJE July 21, 2015
Results First Posted Date  ICMJE November 23, 2015
Last Update Posted Date November 24, 2015
Study Start Date  ICMJE November 2013
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2015)
Asthma Exacerbations Over 48 Weeks Treatment [ Time Frame: 48 weeks treatment ]
The number of asthma exacerbations over 48 weeks treatment will be counted
Original Primary Outcome Measures  ICMJE
 (submitted: September 18, 2013)
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. ]
Annual asthma exacerbation rate (the annual exacerbation rate per patient)
Change History Complete list of historical versions of study NCT01947946 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2013)
  • Assesment of the effect of benralizumab on pulmonary function [ Time Frame: Immediately following the first administration of study drug through Study Week 48. ]
    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. ]
    Asthma symptom score (total, daytime, and night time)
  • Assesment 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. ]
    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. ]
    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. ]
    - 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. ]
    - 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. ]
    Anti-drug antibodies (ADA)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of Benralizumab Added to Medium-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Biological: 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.

  • Biological: Placebo
    Placebo subcutaneously on study week 0 until study week 44 inclusive.
Study Arms  ICMJE
  • Experimental: Benra 30 mg q.4 Weeks
    Fixed 30 mg dose of benralizumab (every 4 weeks)
    Intervention: Biological: Benralizumab
  • Experimental: 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).
    Intervention: Biological: Benralizumab
  • Placebo Comparator: Placebo
    A (Dummy) injection
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 20, 2015)
13
Original Estimated Enrollment  ICMJE
 (submitted: September 18, 2013)
846
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Brazil,   Bulgaria,   Germany,   Poland,   Russian Federation,   United States
Removed Location Countries Japan,   Peru,   Philippines,   South Africa,   Sweden,   Turkey,   Ukraine,   Vietnam
 
Administrative Information
NCT Number  ICMJE NCT01947946
Other Study ID Numbers  ICMJE D3250C00016
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: William W. Busse, MD Allergy, Pulmonary and Critical Care Medicine, Clinical Science Center 600 Highland Ave, Madison, WI USA
PRS Account AstraZeneca
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP