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

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT01851642
Status
Recruiting
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Conditions

  • AAT Deficiency
  • AATD
  • Alpha-1 Antitrypsin Deficiency
  • Cystic Fibrosis (CF)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • History and physical exam. — PROCEDURE
    At every study visit, participant's will be asked about their medical history and will have a physical exam.
  • Blood draw. — PROCEDURE
    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.
  • Pulmonary function testing. — PROCEDURE
    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.
  • Albuterol inhaler. — DRUG
    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.

Study Details

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.

Key Dates

Start date
Aug 9, 2007
Status verified
Nov 2025
Primary completion
Jul 20, 2032
Completion
Jul 20, 2033

Study Design

Enrollment
220 participants (estimated)

Arms

  • Arm: AAT Deficiency
    Those diagnosed with Alpha-1 Antitrypsin (AAT) Deficiency. At every study visit, a history and physical exam (H\&P), blood draw, and pulmonary function testing (PFTs) with the use of an albuterol inhaler will be done.
  • Arm: Cystic Fibrosis
    Those diagnosed with Cystic Fibrosis (CF) with mutation Delta F508. At every study visit, a history and physical exam (H\&P), blood draw, and pulmonary function testing (PFTs) with the use of an albuterol inhaler will be done.
  • Arm: Without Lung Disease Diagnosis
    Those without the diagnosis of AAT Deficiency or CF. At every study visit, a history and physical exam (H\&P), blood draw, and pulmonary function testing (PFTs) with the use of an albuterol inhaler will be done.

Primary Outcome Measure

Evaluation of macrophage function. [ Time Frame: On average, within 30 days from the time the blood is collected. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Shands at the University of FloridaGainesvilleFlorida32610
Allison Faunce, B.A.
[email protected]
352-273-8666
Michelle Owens, RN,BSN
[email protected]
352-273-6339
Karina Serban, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Shands at the University of Florida· Gainesville, FL

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