Status:
RECRUITING
Lung Disease and Its Affect on the Work of White Blood Cells in the Lungs
Lead Sponsor:
University of Florida
Conditions:
Alpha-1 Antitrypsin Deficiency
AAT Deficiency
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to look at how Alpha-1-antitrypsin (AAT) deficiency and Cystic Fibrosis (CF) affect white blood cells in the lungs, called macrophages, and their ability to work.
Detailed Description
AAT deficiency is a genetic disorder that affects around 100,000 people in the USA, including 1-3% of all people diagnosed with chronic obstructive pulmonary disease (COPD). In AAT deficient people di...
Eligibility Criteria
Inclusion
- Signed informed consent
- Male or female 18 years of age or older
- Negative pregnancy test for women of childbearing potential
- Hemoglobin \>12.5 g/dl measured on the day of participation
- Negative urine nicotine test
Exclusion
- Pregnancy or breastfeeding
- Weight \< 50 kg
- History of anemia requiring blood transfusions, erythropoietin supplementation, or iron supplementation within the past 36 months
- Known hemoglobin \<12.5 g/dl within the past 90 days
- Systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \>100 mmHg
- Poor venous access
- Large volume blood donation (\>200 ml or 7 ounces) within the previous 56 days (e.g. blood donation for the purposes of blood banking)
- Clinically significant cardiac, hemostatic or neurological impairment or any other significant medical condition that, in the opinion of the investigator would affect subject safety (e.g., recent myocardial infarction, history of prolonged bleeding time, cerebral vascular accident, advanced cancer or uncontrolled medical condition)
- Psychiatric or cognitive disturbance or illness that would affect subject safety
- Current smoker
Key Trial Info
Start Date :
August 9 2007
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 20 2033
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT01851642
Start Date
August 9 2007
End Date
July 20 2033
Last Update
November 6 2025
Active Locations (1)
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1
Shands at the University of Florida
Gainesville, Florida, United States, 32610