Recruiting

Observational Study

Sponsor:

University of Florida

Code:

NCT01851642

Conditions

Alpha-1 Antitrypsin Deficiency

AAT Deficiency

AATD

Cystic Fibrosis (CF)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

History and physical exam.

Blood draw.

Pulmonary function testing.

Albuterol inhaler.

Study Details

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.

Conditions

Alpha-1 Antitrypsin Deficiency

AAT Deficiency

AATD

Cystic Fibrosis (CF)

Study ID

NCT01851642

Start date

Aug 9, 2007

Status verified date

Nov, 2025

Completion date

Jul 20, 2033

Anticipated

Primary completion date

Jul 20, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

220 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

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.

Interventions

History and physical exam.

At every study visit, participant's will be asked about their medical history and will have a physical exam.

Blood draw.

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.

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.

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Allison E. Faunce, B.A.

352-273-8666Allison.Faunce@medicine.ufl.edu

Michelle Owens, RN, BSN

352-273-6339Sandra.Owens@medicine.ufl.edu

Locations

Shands at the University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Allison Faunce, B.A.

352-273-8666Allison.Faunce@medicine.ufl.edu

Michelle Owens, RN,BSN

352-273-6339Sandra.Owens@medicine.ufl.edu

Principal Investigator:

Karina Serban, MD

More Information

Sponsor

University of Florida

Last update posted

Nov 6, 2025

Last verified

Nov, 2025

Keywords

  • Macrophage
  • Alpha-1 Antitrypsin Deficiency
  • Cystic Fibrosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2025-11-06.