Chronic Obstructive Pulmonary Disease MedDRA version: 21.1 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Provision of informed consent 2 Age 40 to 85 years 3 Male and/or female. 4 Current or former smoker with a tobacco history of =10 pack-years. 5 History of moderate to very severe COPD with a post-bronchodilator FEV1/FVC=65 years) yes F.1.3.1 Number of subjects for this age range 321
Exclusion criteria
Exclusion criteria: 1 Clinically important pulmonary disease other than COPD 2 Current diagnosis of asthma, prior history of asthma or asthma-COPD overlap 3 Radiological findings of a respiratory disease other than COPD contributing to respiratory symptoms. Solitary pulmonary nodules without appropriate follow up or findings of acute infection. 4 Another pulmonary or systemic disease associated with elevated peripheral eosinophil counts. 5 Any unstable disorder that could affect patient safety, study findings or the patient’s ability to complete the study. 6 Any clinically significant abnormal findings in physical examination, vital signs, ECG, laboratory tests could affect patient safety, study findings or the patient’s ability to complete the study. 7 Cor pulmonale and/or right ventricular failure. 8 Long-term treatment with oxygen >4.0 L/min and/or oxyhemoglobin saturation <89% while breathing supplemental oxygen. 9 Use of any non-invasive positive pressure ventilation device (NIPPV). Note: use of CPAP or BiPAP for Sleep Apnea Syndrome is allowed. 10 Known immunodeficiency disorder, including positive HIV-1/2 testing. 11 Active liver disease. Chronic stable hepatitis B and C (including positive HBsAg or hepatitis C antibody testing), or other stable chronic liver disease are acceptable. 12 ALT or AST =3 times the upper limit of normal, confirmed by repeated testing during the run-in period. 13 Helminth parasitic infection within 24 weeks prior to enrollment, not treated or failed to respond to standard of care therapy. 14 Alcohol or drug abuse within the past year, which may compromise the study data. 15 Malignancy, current or within the past 5 years, except for adequately treated non invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma-in-situ treated with apparent success more than 1 year prior to Visit 1. Suspected malignancy or undefined neoplasms. 16 Evidence of active tuberculosis, as judged by investigator. Patients with a recent (within 2 years) first-time or newly positive PPD or Quantiferon test need to complete an appropriate course of treatment before enrollment. Evaluation will be according to the local standard of care. 17 Participation, or planned participation, in intensive COPD rehabilitation program (maintenance phase of a rehabilitation is allowed). 18 History of surgical or endoscopic lung volume reduction within the 6 months prior to enrollment. History of partial or total lung resection (single lobe or segmentectomy is acceptable). 19 Scheduled major surgical procedure during the study. Minor elective procedures are allowed. 20 History of anaphylaxis to any biologic therapy or vaccine. 21 Receipt of blood products or immunoglobulins within 30 days prior to randomization. 22 Receipt of marketed or investigational biologic product within 4 months or 5 half-lives prior to randomization, whichever is longer. Exception: Patients on stable therapy for 3 months before randomization who intend to stay on treatment throughout the study with marketed biologic products that are not likely to interfere with the safety assessment and/or efficacy of benralizumab, for example, for the treatment of osteoporosis, migraine, pain, diabetes, obesity, ocular, cardiovascular, or metabolic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Annualized rate of moderate or severe COPD exacerbations, where a COPD exacerbation is defined by symptomatic worsening of COPD requiring: •Use of systemic corticosteroids for at least 3 days; a single depot injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids; and/or •Use of antibiotics; and/or •An inpatient hospitalization or death due to COPD;Timepoint(s) of evaluation of this end point: over first 56 weeks;Main Objective: To evaluate the effect of benralizumab on COPD exacerbations in patients with moderate to very severe COPD;Secondary Objective: - To evaluate the effect of benralizumab on severe COPD exacerbations (leading to hospitalization or death) - To evaluate the effect of benralizumab on COPD exacerbations involving emergency room visits and hospitalizations - To evaluate the effect of benralizumab on other parameters associated with COPD exacerbations - To evaluate the effect of benralizumab on health status/health-related quality of life - To evaluate the effect of benralizumab on respiratory symptoms - To evaluate the effect of benralizumab on pulmonary function - To evaluate the effect of benralizumab on all cause and respiratory-related mortality - To evaluate the effect of benralizumab on health care resource utilization due to COPD - To evaluate the pharmacokinetics and immunogenicity of benralizumab in this patient population | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Annualized rate of severe COPD exacerbations, where a severe COPD exacerbation is defined by symptomatic worsening of COPD requiring an inpatient hospitalization or results in death due to COPD 2. Annualized rate of COPD exacerbations that are associated with an emergency room/emergency department visit or a hospitalization due to COPD 3. Time to first COPD exacerbation 4. • SGRQ total and domain scores • CAT total score 5. E-RS:COPD total and domain scores 6. Change from baseline in pre-dose/pre-bronchodilator FEV1 at the study site 7. Mortality rate 8. Annual rate of hospitalizations due to COPD; Length of hospital stay; ICU days; annual rate of hospitalizations and emergency department visits combined due to COPD; annual rate of unscheduled outpatient visits including unscheduled visits to study sites due to COPD; and annual rate of unscheduled healthcare encounters due to COPD 9. • Serum benralizumab concentration • Anti-benralizumab antibodies;Timepoint(s) of evaluation of this end point: Over 56 weeks or through End of Treatment | — |
Countries
Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, Czech Republic, Denmark, Germany, Greece, Hungary, Italy, Japan, Korea, Democratic People's Republic of, Mexico, Netherlands, Philippines, Poland, Spain, Sweden, Turkey, United Kingdom, United States
Contacts
Public ContactInformation Center
AstraZenecaAB
Outcome results
None listed