Shands at the University of Florida
Gainesville, Florida, 32610, United States
Location status: Recruiting
Location contact
Allison Faunce, B.A.
CONTACT
Karina Serban, MD
PRINCIPAL_INVESTIGATOR
Michelle Owens, RN,BSN
CONTACT
NCT Number: NCT01851642
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Gainesville, Florida, 32610, United States
Location status: Recruiting
Allison Faunce, B.A.
CONTACT
Karina Serban, MD
PRINCIPAL_INVESTIGATOR
Michelle Owens, RN,BSN
CONTACT
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 diagnosed with COPD, it was originally believed the cause of the disease was due to a lack of supply of alpha-1 antitrypsin. However, early information gathered in our laboratory suggests another cause of the development of COPD and the progressing of the disease may be due to a malfunction in macrophages.
CF is also a genetic disorder which affects 1/300 births among the Caucasian population. One of the main symptoms of CF is inflammation of the lung tissue. Lung macrophages play a major role in lung inflammation as well as in helping to resolve the inflammation.
Inflammation is an important defense of the body. It is the body's response to infection causing germs and things that may cause irritation, as well as, a way for the body to repair damaged tissue.
We suggest that the effects of AAT deficiency and CF decreases the inflammation response in the lungs and also restricts the ability of macrophages to correct that inflammation once it occurs.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
At every study visit, participant's will be asked about their medical history and will have a physical exam.
Other names: H&P
At 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.
Other names: Phlebotomy
At 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.
Other names: PFTs
At 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.
Other names: Ventolin, Proventil, Proventil-HFA, AccuNeb, Vospire, ProAir
Time frame: 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.
Time frame: On average, within 30 days from the time the blood was collected.
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 is collected.
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 testing is completed.
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.
Contact information is provided by the study sponsor or research team.
Allison E. Faunce, B.A.
CONTACT
Michelle Owens, RN, BSN
CONTACT
University of Florida
Other
The Role of Conformational Diseases on Macrophage Function
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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