Lung Disease and Its Affect on the Work of White Blood Cells in the Lungs
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Florida
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Alpha-1 Antitrypsin (AAT) Deficient subjects, Cystic Fibrosis(CF) subjects with mutation Delta F508, and subjects without either diagnosis.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
History and physical exam.
Procedure/SurgeryAt every study visit, participant's will be asked about their medical history and will have a physical exam.
Blood draw.
Procedure/SurgeryAt each study visit, participants will have an intravenous catheter (IV) placed in one of their veins and blood will be drawn from the IV for study testing.
Pulmonary function testing.
Procedure/SurgeryAt every study visit, participants will have their lung function assessed. This is done by blowing forcefully at least 3 times into a tube. Testing will be done two times; before and after the use of an Albuterol inhaler.
Albuterol inhaler.
DrugAt every study visit, participating subjects will take 2 puffs of an Albuterol inhaler after the first set of PFTs, but before the second set of PFTs. There will be at least a 30 minute period after the use of the Albuterol inhaler and the second set of PFTs.
Treatment groups
220 Participants
are divided into 3 treatment groupsGroup A: AAT Deficiency4 interventions
Group B: Cystic Fibrosis4 interventions
Group C: Without Lung Disease Diagnosis4 interventions
Trial outcomes
Primary outcomes
1
Evaluation of macrophage function.
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.
Time frame
On average, within 30 days from the time the blood is collected.Secondary outcomes
1
Comparison of the amount of alpha-1 antitrypsin in the blood.
From every study participant, we will collect blood from a vein through an IV.
Time frame
On average, within 30 days from the time the blood was collected.2
Comparison of the amount of an inflammatory marker in the blood, called C-reactive protein.
From every study participant, we will collect blood from a vein through and IV.
Time frame
On average, within 30 days from the time the blood is collected.3
Evaluation of lung function.
Lung function testing will be done on every study participant. This is is done by forcefully blowing into a tube on at least 3 separate occasions. Albuterol, an inhaled medication used to expand lung airways, will be given after lung function testing and then the testing will be repeated after 30 minutes.
Time frame
On average, within 30 days from the time the testing is completed.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov