Benralizumab Efficacy in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History (GALATHEA)
Investigator: Jonathan D. Brewer, DO, D-ABSM
Contact: Ama Haynes, 541-706-6595 or firstname.lastname@example.org
Location: Bend, Oregon (Central Oregon)
Purpose: The purpose of the study is to determine if benralizumab reduces COPD exacerbation rate in symptomatic patients with moderate to very severe COPD who are receiving standard of care therapies.
2.Subjects 40-85 y.o.
3.Moderate to very severe COPD with Post Bronchodilator (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. Modified Medical Research Council (mMRC) score ≥1 at Visit 1.
6.Treatment with double or triple therapy in 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 Investigational Product (IP) dose until 16 weeks after their last dose.
10.Compliance with maintenance therapy during run-in ≥70%.
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 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.
5. Acute upper or lower respiratory infection requiring antibiotics or antiviral medication within 2 weeks prior to Visit1.
6. Pneumonia within 8 weeks prior to Visit1. 7. Pregnant, breastfeeding, or lactating women. 8. Risk factors for pneumonia 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 within 28 days prior to randomisation. 12. Receipt of any investigational non-biologic product within 30 days or 5 half-lives prior to Visit 1.
13. Evidence of active tuberculosis (TB), either treated or untreated, or latent TB without an appropriate course of treatment.
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 Global Initiative for Asthma (GINA) guidelines or other accepted guidelines.
16. Previous treatment with benralizumab. 17. Helminth parasitic infection diagnosed within 24 weeks prior to Visit 1.
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