A one day study to collect blood and questionnaires from subjects with COPD (chronic obstructive pulmonary disease)

What we are studying

The purpose of this research study is to evaluate an experimental blood test to help doctors know when symptoms associated with COPD are becoming worse. Patients with breathing problems that are not COPD will also be enrolled. Up to 4000 subjects will be enrolled at up to 20 participating sites. Our site will screen 250 participants to get 200 participants enrolled into the study from this site. Experimental tests, such as those used on the blood collected in this study are also known as “investigational.” This means the tests have not been approved by the U.S. Food and Drug Administration (FDA). In this study, the accuracy of these blood tests will be determined by comparing the results with other tests as determined by your study doctor. Your participation in this study will be limited to: Up to 2 study visits for blood draws, with the blood specimen sent to the Sponsor, the disclosure of other tests done to assess your breathing, the disclosure of any treatment you receive or hospitalizations you have, and all disclosures will be sent to the Sponsor.

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 - 80

Eligibility Criteria

  • INCLUSIONS
  • Diagnosed with COPD
  • Be willing to complete questionnaires
  • Be willing to have your blood drawn
  • EXCLUSIONS
  • Any other lung disease including asthma
  • Participated in any other study in the last 30 days
  • Cannot have any uncontrolled illnesses or planning to have any surgeries.

What is involved

  • Informed consent (once)
  • Review Inclusion/Exclusion criteria (once)
  • Review Demographic data (once)
  • Review Medical history (twice)
  • Physical Exam/Clinical Assessment (twice)
  • Subject Questionnaire (twice)
  • Blood draw (twice)

Compensation

You will be paid $100.00 for each completed study visit 1 and $75.00 for visit 2 (visit 2 only occurs if you develop COPD exacerbation and/or more severe COPD symptoms). If you do not complete the study, you will be paid for completed visits.

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.