A study to try a new COPD medication (Galathea)

What we are studying

This study will use an experimental drug called benralizumab to treat moderate to very severe Chronic Obstructive Pulmonary Disease (COPD). “Experimental” means that the drug has not been approved by any Authority that regulates new medicines, including the US Food and Drug Administration (FDA).You have been asked to consider taking part in this study because you have been diagnosed with moderate, severe or very severe COPD that is not well controlled. This study is being carried out to evaluate benralizumab (study drug) as a treatment for moderate to very severe COPD compared with placebo (an inactive substance). COPD is a general term that includes chronic bronchitis (swelling and irritation in the airways) and emphysema (destruction of the air sacs and the walls separating the air sacs so that they become floppy and less able to transport oxygen). This results in symptoms such as cough, shortness of breath, chest tightness and sputum production. COPD is generally a progressive disease that gets worse over time and is associated with flare-ups also called exacerbations. This study will explore in what dose benralizumab needs to be given, who responds best to benralizumab, and how well benralizumab is tolerated. This study will measure levels of benralizumab in the blood and see how the body accepts the study drug.

Who we are studying

  • Men and Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 40 - 85

Eligibility Criteria

  • History of moderate to very severe COPD
  • History of 2 or more moderate COPD exacerbations that required treatment with systemic corticosteroids and/or antibiotics or 1 or more severe COPD exacerbation(s) that required hospitalization
  • Subjects should have evidence of having been treated with double (ICS/LABA or LABA/LAMA) or triple (ICS/LABA/LAMA) therapy for COPD throughout the year prior to enrolment
  • Current smoker or ex-smoker
  • You cannot have:
    • Clinically important pulmonary disease other than COPD (e.g. active lung infection
    • Clinically significant bronchiectasis
    • Pulmonary fibrosis
    • Cystic fibrosis
    • Hypoventilation syndrome associated with obesity
    • Lung cancer
    • Alpha 1 anti-trypsin deficiency and primary ciliary dyskinesia) or another diagnosed pulmonary or systemic disease that is associated with elevated peripheral eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis
    • Churg-Strauss syndrome
    • Hypereosinophilic syndrome) and/ or radiological findings suggestive of a respiratory disease other than COPD that is contributing to the subject’s respiratory symptoms
  • Any disorder including but not limited to cardiovascular; gastrointestinal; hepatic; renal; neurological; musculoskeletal; infectious; endocrine; metabolic; haematological; psychiatric; or major physical impairment

What is involved

  • Physical exam
  • Chest X-ray
  • Height and weight and vital signs
  • Electrocardiogram (ECG)
  • Blood sampling
  • Urine sampling
  • Spirometry (lung function measurements)
  • Pulse oximetry
  • Questionnaires
  • Complete an electronic diary (eDiary)
  • Administration of study drug
  • Additional procedures

Compensation

If you complete all the scheduled study visits, you will be paid $1000.00. If you withdraw for any reason before completion of the study you will be paid $50.00 for each completed visit.

Contact Information

Study Coordinator
Bob Hmieleski
Email
bhmieles@wakehealth.edu
Phone
336-713-8550
Principal Investigator
Eugene Bleecker, MD

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.