Randomised, double-blind, chronic dosing (56 week) placebo-controlled, parallel group, multicentre, phase 3 study to evaluate the efficacy and safety of 2 doses of benralizumab (MEDI-563) in patients with moderate to very severe Chronic Ostructive Pulmonary Disease (COPD) with a history of COPD exacerbations (GALATHEA)
- Conditions
- Chronic Obstructive Pulmonary DiseaseCOPD10006436
- Registration Number
- NL-OMON41749
- Lead Sponsor
- Astra Zeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 36
1.Informed consent. ;2.Subjects 40-85 y.o. ;3.Moderate to very severe COPD with post-BD FEV1>20% and *65% . ;4.*2 moderate or *1 severe COPD exacerbation(s) required treatment or hospitalization within 2-52 weeks prior to Visit1. ;5.mMRC score *1 at Visit 1. ;6.Treatment with double or triple therapy throughout the year prior to Visit 1, constant 2 weeks prior to Visit 1. ;7.Tobacco history of *10 pack-years. ;8.Women of childbearing potential must use a highly effective form of birth control from Visit 1 until 16 weeks after their last dose, and negative serum pregnancy test result at Visit 1. ;9.Male subjects who are sexually active must be surgically sterile one year prior to Visit 1 or use an adequate method of contraception from the first IP dose until 16 weeks after their last dose. ;10.Compliance with maintenance therapy during run-in *70% from visit 2 to visit 4.
1. Clinically important pulmonary disease other than COPD or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.;2. Any disorder or major physical impairment that is not stable by Investigator opinion and/or could affect: - subject safety*study findings or their interpretation or subject*s ability to complete the entire study duration.;3. Unstable ischemic heart disease, arrhythmia, cardiomyopathy, or other relevant cardiovascular disorder that in Investigator*s judgment may put the patient at risk or negatively affect the study outcome.;4. Treatment with systemic corticosteroids and/or antibiotics, and/or hospitalization for a COPD exacerbation within 2 weeks prior to Visit1 or during the enrolment and screening/run-in period.;5. Acute upper or lower respiratory infection requiring antibiotics or antiviral medication within 2 weeks prior to Visit1 or during the enrolment and screening/run-in period.;6. Pneumonia within 8 weeks prior to Visit1 or during the enrolment and screening/run-in period.;7. Pregnant, breastfeeding, or lactating women.;8. Risk factors for pneumonia (including but not limited to: immunosuppression, neurological disorder with increased risk of aspiration).;9. History of anaphylaxis to any other biologic therapy. ;10. Long term oxygen therapy with signs and/or symptoms of cor pulmonale, right ventricular failure. ;11. Use of immunosuppressive medication , including rectal corticosteroids and systemic steroids within 2 weeks prior to enrolment (visit1) and/or during the enrolment/screening/run-in period. ;12. Receipt of any investigational non-biologic product within 30 days or 5 half-lives prior to Visit 1. ;13. Subjects who in the opinion of the investigator or qualified designee have evidence of active
tuberculosis (TB). Subjects with a recent (within 2 years) first-time or newly positive
purified protein derivative (PPD) test or Quantiferon test need to complete an
appropriate course of treatment before being considered for enrolment.;14. Lung volume reduction surgery within the 6 months prior to Visit 1. History of partial or total lung resection (single lobe or segmentectomy is acceptable). ;15. Asthma as a primary or main diagnosis according to the GINA guidelines or other accepted guidelines. ;16. Previous treatment with benralizumab.;17. Helminth parasitic infection diagnosed within 24 weeks prior to Visit 1.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome measure:<br /><br><br /><br>Annual COPD exacerbation rate, where a COPD exacerbation is defined by<br /><br>symptomatic worsening of COPD requiring:<br /><br>- Use of systemic corticosteroids for at least 3 days. A single depot<br /><br>injectable dose of corticosteroids will be considered equivalent to a 3- day<br /><br>course of systemic corticosteroids; and /or<br /><br>- Use of antibiotics; and/or<br /><br>- an inpatient hospitalization due to COPD.</p><br>
- Secondary Outcome Measures
Name Time Method