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

Last updated: October 21, 2024
Sponsor: University of Florida
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cystic Fibrosis

Alpha 1 Antitrypsin Deficiency

Liver Disorders

Treatment

Pulmonary function testing.

History and physical exam.

Blood draw.

Clinical Study ID

NCT01851642
IRB201501051
699
08-2007
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Pregnancy or breastfeeding

  • Weight < 50 kg

  • History of anemia requiring blood transfusions, erythropoietin supplementation, oriron 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 othersignificant medical condition that, in the opinion of the investigator would affectsubject safety (e.g., recent myocardial infarction, history of prolonged bleedingtime, cerebral vascular accident, advanced cancer or uncontrolled medical condition)

  • Psychiatric or cognitive disturbance or illness that would affect subject safety

  • Current smoker

Study Design

Total Participants: 220
Treatment Group(s): 4
Primary Treatment: Pulmonary function testing.
Phase:
Study Start date:
August 09, 2007
Estimated Completion Date:
July 20, 2033

Study Description

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.

Connect with a study center

  • Shands at the University of Florida

    Gainesville, Florida 32610
    United States

    Active - Recruiting

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