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Benralizumab Airway Remodeling Study in Severe Eosinophilic Asthmatics (CHINOOK)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03953300
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : November 7, 2022
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE April 10, 2019
First Posted Date  ICMJE May 16, 2019
Last Update Posted Date November 7, 2022
Actual Study Start Date  ICMJE October 17, 2019
Estimated Primary Completion Date September 30, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
  • The change in eosinophil numbers expressed as number/mm2 in submucosa as measured by major basic protein (MBP) staining in endobronchial biopsies [ Time Frame: From baseline to Week 48 (Visit 10) ]
    The change in eosinophil numbers expressed as number/mm2 in submucosa as measured by major basic protein (MBP) staining in endobronchial biopsies
  • The change in airway wall area percentage as the overall median for airway generations 3 and 4 combined as measured by quantitative computed tomography (QCT) imaging [ Time Frame: From baseline to Week 48 (Visit 10) ]
    The change in airway wall area percentage as the overall median for airway generations 3 and 4 combined as measured by quantitative computed tomography (QCT) imaging
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2022)
  • The change in eosinophil numbers, expressed as number/mm2 in epithelium as measured by major basic protein (MBP) staining in endobronchial biopsies [ Time Frame: From baseline to Week 48 (Visit 10) ]
    The change in eosinophil numbers, expressed as number/mm2 in epithelium as measured by major basic protein (MBP) staining in endobronchial biopsies
  • The change in eosinophil numbers, expressed as number/mm2 in epithelium and submucosa as measured by major basic protein (MBP) staining in endobronchial biopsies [ Time Frame: From baseline to Week 48 (Visit 10) ]
    The change in eosinophil numbers, expressed as number/mm2 in epithelium and submucosa as measured by major basic protein (MBP) staining in endobronchial biopsies
  • Absolute change in air trapping of the lung with expiratory density less than -856 Hounsfield Units (HU), and as expiratory-to-inspiratory ratio of mean lung density on computed tomography (CT) scans [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Absolute change in air trapping of the lung with expiratory density less than -856 Hounsfield Units (HU), and as expiratory-to-inspiratory ratio of mean lung density on computed tomography (CT) scans
  • Absolute change in air trapping/small airway obstruction derived from regional matching of the inspiratory/expiratory computed tomography (CT) scans [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Absolute change in air trapping/small airway obstruction derived from regional matching of the inspiratory/expiratory computed tomography (CT) scans
  • Change in airway lumen volume and airway resistance as measured by quantitative computed tomography (QCT) [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Change in airway lumen volume and airway resistance as measured by quantitative computed tomography (QCT)
  • Change in endobronchial biopsies on airway epithelial cell integrity [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Change in endobronchial biopsies on airway epithelial cell integrity
  • Change in endobronchial biopsies on reticular basement membrane (RBM) thickening [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Change in endobronchial biopsies on reticular basement membrane (RBM) thickening
  • Change in endobronchial biopsies on vascularization of the sub-mucosa [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Change in endobronchial biopsies on vascularization of the sub-mucosa
  • Assessments of peripheral airway resistance measured by AO [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Assessments of peripheral airway resistance measured by AO
  • Change in endobronchial biopsies on mucin 5AC, oligomeric mucus/gel-forming (MUC5AC) [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Change in endobronchial biopsies on mucin 5AC, oligomeric mucus/gel-forming (MUC5AC)
  • Absolute change in R5-R20 (peripheral airway resistance defined as the difference in resistance between 5 Hz [R5, total respiratory system resistance] and 20 Hz [R20, central resistance]) as measured by airwave oscillometry (AO) [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Absolute change in R5-R20 (peripheral airway resistance defined as the difference in resistance between 5 Hz [R5, total respiratory system resistance] and 20 Hz [R20, central resistance]) as measured by airwave oscillometry (AO)
  • Absolute change in area under the reactance curve (AX) as measured by airwave oscillometry (AO) [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Absolute change in area under the reactance curve (AX) as measured by airwave oscillometry (AO)
  • Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) residual volume (RV) [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) residual volume (RV)
  • Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) total lung capacity (TLC) [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) total lung capacity (TLC)
  • Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) inspiratory capacity (IC) [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) inspiratory capacity (IC)
  • Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) RV/TLC ratio [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) residual volume / total lung capacity (RV/TLC) ratio
  • Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP)functional residual capacity (FRC) [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP)functional residual capacity (FRC)
  • Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) vital capacity (VC) [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) vital capacity (VC)
  • Absolute change in post-bronchodilator (BD) whole body plethysmogrpahy (WBP) residual volume (RV) [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Absolute change in post-bronchodilator (BD) whole body plethysmogrpahy (WBP) residual volume (RV)
  • Absolute change in post-bronchodilator (BD) whole body plethysmogrpahy (WBP) total lung capacity (TLC) [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Absolute change in post-bronchodilator (BD) whole body plethysmogrpahy (WBP) total lung capacity (TLC)
  • Absolute change in post-bronchodilator (BD) whole body plethysmogrpahy (WBP) inspiratory capacity (IC) [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Absolute change in post-bronchodilator (BD) whole body plethysmogrpahy (WBP) inspiratory capacity (IC)
  • Absolute change in post-bronchodilator (BD) whole body plethysmogrpahy (WBP) RV/TLC ratio [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Absolute change in post-bronchodilator (BD) whole body plethysmogrpahy (WBP) residual volume / total lung capacity(RV/TLC) ratio
  • Absolute change in post-bronchodilator (BD) whole body plethysmogrpahy (WBP)functional residual capacity (FRC) [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Absolute change in post-bronchodilator (BD) whole body plethysmogrpahy (WBP)functional residual capacity (FRC)
  • Absolute change in post-bronchodilator (BD) whole body plethysmogrpahy (WBP) vital capacity (VC) [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Absolute change in post-bronchodilator (BD) whole body plethysmogrpahy (WBP) vital capacity (VC)
  • Change from pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) to post-BD WBP residual volume (RV) [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Change from pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) to post-BD WBP residual volume (RV)
  • Change from pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) to post-BD WBP total lung capacity (TLC) [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Change from pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) to post-BD WBP total lung capacity (TLC)
  • Change from pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) to post-BD WBP inspiratory capacity (IC) [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Change from pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) to post-BD WBP inspiratory capacity (IC)
  • Change from pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) to post-BD WBP RV/TLC ratio [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Change from pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) to post-BD WBP residual volume / total lung capacity (RV/TLC) ratio
  • Change from pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) to post-BD WBP functional residual capacity (FRC) [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Change from pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) to post-BD WBP functional residual capacity (FRC)
  • Change from pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) to post-BD WBP vital capacity (VC) [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Change from pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) to post-BD WBP vital capacity (VC)
  • Change in post-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) as measured by spirometry [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Change in post-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) as measured by spirometry
  • Change in post-bronchodilator (BD) forced vital capacity (FVC) as measured by spirometry [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Change in post-bronchodilator (BD) forced vital capacity (FVC) as measured by spirometry
  • Change in post-bronchodilator (BD) FEV1/FVC as measured by spirometry [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Change in post-bronchodilator (BD) FEV1/FVC as measured by spirometry
  • Change in basophil number (number/mm2) in endobronchial biopsies as measured by immunohistochemistry (IHC) [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Change in basophil number (number/mm2) in endobronchial biopsies as measured by immunohistochemistry (IHC)
Original Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
  • The change in eosinophil numbers, expressed as number/mm2 in epithelium as measured by major basic protein (MBP) staining in endobronchial biopsies [ Time Frame: From baseline to Week 48 (Visit 10) ]
    The change in eosinophil numbers, expressed as number/mm2 in epithelium as measured by major basic protein (MBP) staining in endobronchial biopsies
  • The change in eosinophil numbers, expressed as number/mm2 in epithelium and submucosa as measured by major basic protein (MBP) staining in endobronchial biopsies [ Time Frame: From baseline to Week 48 (Visit 10) ]
    The change in eosinophil numbers, expressed as number/mm2 in epithelium and submucosa as measured by major basic protein (MBP) staining in endobronchial biopsies
  • Absolute change in air trapping of the lung with expiratory density less than -856 Hounsfield Units (HU), and as expiratory-to-inspiratory ratio of mean lung density on computed tomography (CT) scans [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Absolute change in air trapping of the lung with expiratory density less than -856 Hounsfield Units (HU), and as expiratory-to-inspiratory ratio of mean lung density on computed tomography (CT) scans
  • Absolute change in air trapping/small airway obstruction derived from regional matching of the inspiratory/expiratory computed tomography (CT) scans [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Absolute change in air trapping/small airway obstruction derived from regional matching of the inspiratory/expiratory computed tomography (CT) scans
  • Change in airway lumen volume and airway resistance as measured by quantitative computed tomography (QCT) [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Change in airway lumen volume and airway resistance as measured by quantitative computed tomography (QCT)
  • Change in endobronchial biopsies on airway epithelial cell integrity [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Change in endobronchial biopsies on airway epithelial cell integrity
  • Change in endobronchial biopsies on reticular basement membrane (RBM) thickening [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Change in endobronchial biopsies on reticular basement membrane (RBM) thickening
  • Change in endobronchial biopsies on vascularization of the sub-mucosa [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Change in endobronchial biopsies on vascularization of the sub-mucosa
  • Change in endobronchial biopsies on airway smooth muscle mass percentage [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Change in endobronchial biopsies on airway smooth muscle mass percentage
  • Change in endobronchial biopsies on mucin 5AC, oligomeric mucus/gel-forming (MUC5AC) [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Change in endobronchial biopsies on mucin 5AC, oligomeric mucus/gel-forming (MUC5AC)
  • Absolute change in R5-R20 (peripheral airway resistance defined as the difference in resistance between 5 Hz [R5, total respiratory system resistance] and 20 Hz [R20, central resistance]) as measured by airwave oscillometry (AO) [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Absolute change in R5-R20 (peripheral airway resistance defined as the difference in resistance between 5 Hz [R5, total respiratory system resistance] and 20 Hz [R20, central resistance]) as measured by airwave oscillometry (AO)
  • Absolute change in area under the reactance curve (AX) as measured by airwave oscillometry (AO) [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Absolute change in area under the reactance curve (AX) as measured by airwave oscillometry (AO)
  • Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) residual volume (RV) [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) residual volume (RV)
  • Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) total lung capacity (TLC) [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) total lung capacity (TLC)
  • Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) inspiratory capacity (IC) [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) inspiratory capacity (IC)
  • Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) RV/TLC ratio [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) residual volume / total lung capacity (RV/TLC) ratio
  • Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP)functional residual capacity (FRC) [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP)functional residual capacity (FRC)
  • Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) vital capacity (VC) [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) vital capacity (VC)
  • Absolute change in post-bronchodilator (BD) whole body plethysmogrpahy (WBP) residual volume (RV) [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Absolute change in post-bronchodilator (BD) whole body plethysmogrpahy (WBP) residual volume (RV)
  • Absolute change in post-bronchodilator (BD) whole body plethysmogrpahy (WBP) total lung capacity (TLC) [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Absolute change in post-bronchodilator (BD) whole body plethysmogrpahy (WBP) total lung capacity (TLC)
  • Absolute change in post-bronchodilator (BD) whole body plethysmogrpahy (WBP) inspiratory capacity (IC) [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Absolute change in post-bronchodilator (BD) whole body plethysmogrpahy (WBP) inspiratory capacity (IC)
  • Absolute change in post-bronchodilator (BD) whole body plethysmogrpahy (WBP) RV/TLC ratio [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Absolute change in post-bronchodilator (BD) whole body plethysmogrpahy (WBP) residual volume / total lung capacity(RV/TLC) ratio
  • Absolute change in post-bronchodilator (BD) whole body plethysmogrpahy (WBP)functional residual capacity (FRC) [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Absolute change in post-bronchodilator (BD) whole body plethysmogrpahy (WBP)functional residual capacity (FRC)
  • Absolute change in post-bronchodilator (BD) whole body plethysmogrpahy (WBP) vital capacity (VC) [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Absolute change in post-bronchodilator (BD) whole body plethysmogrpahy (WBP) vital capacity (VC)
  • Change from pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) to post-BD WBP residual volume (RV) [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Change from pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) to post-BD WBP residual volume (RV)
  • Change from pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) to post-BD WBP total lung capacity (TLC) [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Change from pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) to post-BD WBP total lung capacity (TLC)
  • Change from pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) to post-BD WBP inspiratory capacity (IC) [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Change from pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) to post-BD WBP inspiratory capacity (IC)
  • Change from pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) to post-BD WBP RV/TLC ratio [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Change from pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) to post-BD WBP residual volume / total lung capacity (RV/TLC) ratio
  • Change from pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) to post-BD WBP functional residual capacity (FRC) [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Change from pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) to post-BD WBP functional residual capacity (FRC)
  • Change from pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) to post-BD WBP vital capacity (VC) [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Change from pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) to post-BD WBP vital capacity (VC)
  • Change in post-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) as measured by spirometry [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Change in post-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) as measured by spirometry
  • Change in post-bronchodilator (BD) forced vital capacity (FVC) as measured by spirometry [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Change in post-bronchodilator (BD) forced vital capacity (FVC) as measured by spirometry
  • Change in post-bronchodilator (BD) FEV1/FVC as measured by spirometry [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Change in post-bronchodilator (BD) FEV1/FVC as measured by spirometry
  • Change in basophil number (number/mm2) in endobronchial biopsies as measured by immunohistochemistry (IHC) [ Time Frame: From baseline to Week 48 (Visit 10) ]
    Change in basophil number (number/mm2) in endobronchial biopsies as measured by immunohistochemistry (IHC)
Current Other Pre-specified Outcome Measures
 (submitted: July 5, 2022)
The number of Adverse events (AEs)/serious adverse events (SAEs). [ Time Frame: From baseline to Week 52 (Visit 11) ]
Original Other Pre-specified Outcome Measures
 (submitted: May 14, 2019)
Number of Adverse events (AEs)/serious adverse events (SAEs). [ Time Frame: From baseline to Week 52 (Visit 11) ]
Number of Adverse events (AEs)/serious adverse events (SAEs).
 
Descriptive Information
Brief Title  ICMJE Benralizumab Airway Remodeling Study in Severe Eosinophilic Asthmatics
Official Title  ICMJE A Phase 4, Multicenter, Randomized, Double-blind, Parallel Group, Placebo Controlled Study to Evaluate the Effect of Benralizumab on Structural and Lung Function Changes in Severe Eosinophilic Asthmatics
Brief Summary

The purpose of the study is to evaluate effect of benralizumab on structural and lung function changes in severe eosinophilic asthmatics.

Changes will be assessed over 48 week treatment period in patients with persistent symptoms despite standard therapy of inhaled corticosteroids (ICS) plus long acting B2-agonist (LABA) with or without additional controller medication.

Patients who complete treatment will enter 4 weeks follow-up period.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
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
    Benralizumab: 30 mg/mL solution for injection in accessorized prefilled syringe (APFS) will be administered subcutaneously (SC) every 4 weeks for the first 3 doses - Weeks 0, 4 and 8, and then every 8 weeks - Weeks 16, 24, 32, 40.
  • Biological: Placebo
    Matching placebo will be administered subcutaneously with accessorized prefilled syringe (APFS) every 4 weeks for the first 3 doses - Weeks 0, 4 and 8, and then every 8 weeks - Weeks 16, 24, 32, 40.
Study Arms  ICMJE
  • Experimental: Benralizumab
    Administrated subcutaneously (SC) every 4 weeks for the first 3 doses, then every 8 weeks
    Intervention: Biological: Benralizumab
  • Placebo Comparator: Placebo
    Administrated subcutaneously every 4 weeks for the first 3 doses, then every 8 weeks
    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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 14, 2019)
81
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2025
Estimated Primary Completion Date September 30, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female aged 18 through 70 years.
  2. Physician-diagnosed asthma requiring continuous treatment with medium- or high-dose ICS plus LABA with or without additional controller medication for at least 12 months prior to Visit 1, and current treatment with high-dose ICS plus LABA for at least 3 months prior to Visit 1 with or without additional asthma maintenance medication.
  3. Morning pre-BD FEV1 ≥50 to <80% of predicted normal value (PNV) and ≥1 liter (L) or morning pre-BD FEV1 ≥ 50 to < 90% of PNV, if historical pre-BD FEV1 value (within 12 months prior to screening visit) was < 80% of PNV.
  4. A blood eosinophil count of: ≥300 cells/µL during screening or ≥150 to <300 cells/µL during screening plus one of the following: presence of nasal polyps or pre-BD FVC <65% predicted at Visit 2 or sputum eosinophil count of ≥2% at Visit 2.
  5. Negative pregnancy test.
  6. Asthma control questionnaire (ACQ-6) >1.5.
  7. Fewer than 12 exacerbations within the 6 months prior to Visit 3.

Exclusion Criteria:

  1. Any disease or concomitant medication which could affect study results or safety of study participants, including:

    • current smokers
    • history of cancer
    • life-threatening asthma
    • clinically important pulmonary disease other than asthma
  2. Use of chronic immunosuppressive medication or receipt of immunoglobulin (or blood products) within 30 days prior to the date informed consent is obtained.
  3. Previously received:

    • benralizumab
    • live attenuated vaccines 30 days prior to the date of randomization.
    • bronchial thermoplasty in the last 24 months prior to Visit 1
    • any investigational non-biologic within 22 days (or 5 half-lives) prior to the date informed consent is obtained, whichever is longer.
    • any marketed or investigational biologic within 4 months (or 5 half-lives) prior to the date informed consent is obtained, whichever is longer.
  4. Currently pregnant, breastfeeding or lactating women.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
Listed Location Countries  ICMJE Canada,   Denmark,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03953300
Other Study ID Numbers  ICMJE D3250C00059
2018-003391-13 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home
Current Responsible Party AstraZeneca
Original Responsible Party Same as current
Current Study Sponsor  ICMJE AstraZeneca
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mario Castro, MD University of Kansas School of Medicine 3901 Rainbow Blvd. Kansas City, KS 66160, United States of America (USA)
PRS Account AstraZeneca
Verification Date November 2022

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