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

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Brief Title

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

Official Title

The Role of Conformational Diseases on Macrophage Function

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.
    

Detailed 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.
    


Study Type

Observational


Primary Outcome

Evaluation of macrophage function.

Secondary Outcome

 Comparison of the amount of alpha-1 antitrypsin in the blood.

Condition

Alpha-1 Antitrypsin Deficiency

Intervention

History and physical exam.

Study Arms / Comparison Groups

 AAT Deficiency
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

220

Start Date

September 2007

Completion Date

November 2020

Primary Completion Date

September 2020

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Mark Brantly, MD, 352-273-8666, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01851642

Organization ID

IRB201501051

Secondary IDs

699

Responsible Party

Sponsor

Study Sponsor

University of Florida


Study Sponsor

Mark Brantly, MD, Principal Investigator, University of Florida, College of Medicine, Division of Pulmonary, Critical Care, and Sleep Medicine


Verification Date

August 2019