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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01851642
First received: April 25, 2013
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Alpha-1 Antitrypsin Deficiency
AAT Deficiency
AATD
Cystic Fibrosis (CF)
Procedure: History and physical exam.
Procedure: Blood draw.
Procedure: Pulmonary function testing.
Drug: Albuterol inhaler.
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: The Role of Conformational Diseases on Macrophage Function

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Evaluation of macrophage function. [ Time Frame: On average, within 30 days from the time the blood is collected. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Comparison of the amount of alpha-1 antitrypsin in the blood. [ Time Frame: On average, within 30 days from the time the blood was collected. ] [ Designated as safety issue: No ]
    From every study participant, we will collect blood from a vein through an IV.

  • Comparison of the amount of an inflammatory marker in the blood, called C-reactive protein. [ Time Frame: On average, within 30 days from the time the blood is collected. ] [ Designated as safety issue: No ]
    From every study participant, we will collect blood from a vein through and IV.

  • Evaluation of lung function. [ Time Frame: On average, within 30 days from the time the testing is completed. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 200
Study Start Date: September 2007
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Procedure: History and physical exam.
At every study visit, participant's will be asked about their medical history and will have a physical exam.
Other Name: H&P
Procedure: 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.
Other Name: Phlebotomy
Procedure: 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.
Other Name: PFTs
Drug: 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.
Other Names:
  • Ventolin
  • Proventil
  • Proventil-HFA
  • AccuNeb
  • Vospire
  • ProAir
Active Comparator: 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.
Procedure: History and physical exam.
At every study visit, participant's will be asked about their medical history and will have a physical exam.
Other Name: H&P
Procedure: 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.
Other Name: Phlebotomy
Procedure: 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.
Other Name: PFTs
Drug: 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.
Other Names:
  • Ventolin
  • Proventil
  • Proventil-HFA
  • AccuNeb
  • Vospire
  • ProAir
Active Comparator: 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.
Procedure: History and physical exam.
At every study visit, participant's will be asked about their medical history and will have a physical exam.
Other Name: H&P
Procedure: 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.
Other Name: Phlebotomy
Procedure: 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.
Other Name: PFTs
Drug: 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.
Other Names:
  • Ventolin
  • Proventil
  • Proventil-HFA
  • AccuNeb
  • Vospire
  • ProAir

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01851642

Contacts
Contact: Tracie L Kurtz, RN 866-229-6313 tlkurtz@ufl.edu
Contact: Pam Schreck, RN, MSN 352-294-5195 pschreck@ufl.edu

Locations
United States, Florida
Shands at the University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Tracie L Kurtz, RN    866-229-6313    tlkurtz@ufl.edu   
Contact: Pam Schreck, RN,MSN    352-294-5195    pschreck@ufl.edu   
Principal Investigator: Mark Brantly, MD         
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Mark Brantly, MD University of Florida, College of Medicine, Division of Pulmonary, Critical Care, and Sleep Medicine
  More Information

Additional Information:
Publications:

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01851642     History of Changes
Other Study ID Numbers: 08-2007, 699
Study First Received: April 25, 2013
Last Updated: July 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Macrophage
Alpha-1 Antitrypsin Deficiency
Cystic Fibrosis

Additional relevant MeSH terms:
Alpha 1-Antitrypsin Deficiency
Cystic Fibrosis
Fibrosis
Digestive System Diseases
Emphysema
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Liver Diseases
Lung Diseases
Pancreatic Diseases
Pathologic Processes
Respiratory Tract Diseases
Subcutaneous Emphysema
Albuterol
Alpha 1-Antitrypsin
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Reproductive Control Agents

ClinicalTrials.gov processed this record on October 29, 2014