Trial record 1 of 3 for:
alpha-1 antitrypsin and macrophage
Lung Disease and Its Affect on the Work of White Blood Cells in the Lungs
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01851642 |
|
Recruitment Status :
Recruiting
First Posted : May 10, 2013
Last Update Posted : August 24, 2018
|
Sponsor:
University of Florida
Information provided by (Responsible Party):
University of Florida
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment |
|---|---|
| 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. |
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 |
| Estimated Enrollment : | 220 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Official Title: | The Role of Conformational Diseases on Macrophage Function |
| Actual Study Start Date : | September 2007 |
| Estimated Primary Completion Date : | September 2019 |
| Estimated Study Completion Date : | November 2019 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Albuterol
| Group/Cohort | Intervention/treatment |
|---|---|
|
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:
|
|
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:
|
|
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:
|
Primary Outcome Measures :
- Evaluation of macrophage function. [ Time Frame: On average, within 30 days from the time the blood is collected. ]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. ]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. ]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. ]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.
Biospecimen Retention: Samples With DNA
Whole blood and plasma.
Information from the National Library of Medicine
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Alpha-1 Antitrypsin (AAT) Deficient subjects, Cystic Fibrosis(CF) subjects with mutation Delta F508, and subjects without either diagnosis.
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01851642
Contacts
| Contact: Jesse West, RN | 352-273-8666 | jesse.west@medicine.ufl.edu | |
| Contact: Christina Eagan, RN, BSN | 352-273-8990 | christina.eagan@medicine.ufl.edu |
Locations
| United States, Florida | |
| Shands at the University of Florida | Recruiting |
| Gainesville, Florida, United States, 32610 | |
| Contact: Jesse West, RN 352-273-8666 jesse.west@medicine.ufl.edu | |
| Contact: Christina Eagan, RN,BSN 352-273-8990 christina.eagan@medicine.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 |
Additional Information:
Publications:
| Responsible Party: | University of Florida |
| ClinicalTrials.gov Identifier: | NCT01851642 History of Changes |
| Other Study ID Numbers: |
IRB201501051 699 ( Other Identifier: Shands UF Clinical Research Center ) 08-2007 ( Other Identifier: University of Florida ) |
| First Posted: | May 10, 2013 Key Record Dates |
| Last Update Posted: | August 24, 2018 |
| Last Verified: | August 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Enrolled subjects may request a copy of their clinical testing done while enrolled in the clinical trial. All other data used for publication purposes will be de-identified. |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by University of Florida:
|
Macrophage Alpha-1 Antitrypsin Deficiency Cystic Fibrosis |
Additional relevant MeSH terms:
|
Alpha 1-Antitrypsin Deficiency Alpha 1-Antitrypsin Fibrosis Cystic Fibrosis Pathologic Processes Pancreatic Diseases Digestive System Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Liver Diseases Subcutaneous Emphysema Emphysema Albuterol |
Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Tocolytic Agents Reproductive Control Agents Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Trypsin Inhibitors |