Observational Study: Lung Disease and White Blood Cells

This observational study is looking at how Alpha-1 Antitrypsin Deficiency (AATD) and Cystic Fibrosis (CF) affect white blood cells in the lungs called macrophages. Macrophages are important for fighting infection and repairing tissue. Researchers believe that in people with AATD and CF, macrophages might not work as well, which could lead to ongoing inflammation in the lungs. You would have a physical exam, blood draws, and lung function tests (Pulmonary Function Tests or PFTs) where you blow into a tube. You would also use an Albuterol inhaler between two sets of PFTs. The study aims to understand how well these macrophages are working. This study is currently unclear on its recruitment status and plans to enroll 220 participants.

Study design
This is an observational study, meaning researchers will observe participants without assigning specific treatments. It aims to enroll 220 participants.
What's involved
At every study visit, you would have a medical history review, physical exam, blood draw, and pulmonary function tests. You would also use an Albuterol inhaler during the lung function testing.
Compensation
Not stated in the trial record.
Follow-up
Macrophage function will be evaluated, on average, within 30 days from when blood is collected.

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NCT01851642

Lung Disease and Its Affect on the Work of White Blood Cells in the Lungs

Recruiting
Not specifiedAges 18+Observational
University of Florida
~220 participants
Updated 2025-11-06 on ClinicalTrials.gov
What's tested:History and physical exam.Blood draw.Pulmonary function testing.Albuterol inhaler.

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluation of macrophage function.
Measured over On average, within 30 days from the time the blood is collected.
Alpha-1 Antitrypsin Deficiency
AAT Deficiency
AATD
Cystic Fibrosis (CF)
1 sites across 1 states
Florida1
  • Karina Serban, MD · PRINCIPAL_INVESTIGATOR · University of Florida, College of Medicine, Division of Pulmonary, Critical Care, and Sleep Medicine

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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
  • Evaluation of macrophage function.On average, within 30 days from the time the blood is collected.

    From every study participant, we will collect blood from a vein through the placement of an intravenous catheter (IV). We will complete various experiments that will allow us to see how well each participant's macrophage cells are working.