The Role of Conformational Diseases on Macrophage Function
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Evaluation of macrophage function.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: History and physical exam. (Procedure)
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.
干预措施: Blood draw. (Procedure)
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.
干预措施: Pulmonary function testing. (Procedure)
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.
干预措施: Albuterol inhaler. (Drug)
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.
干预措施: History and physical exam. (Procedure)
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.
干预措施: Blood draw. (Procedure)
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.
干预措施: Pulmonary function testing. (Procedure)
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.
干预措施: Albuterol inhaler. (Drug)
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.
干预措施: History and physical exam. (Procedure)
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.
干预措施: Blood draw. (Procedure)
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.
干预措施: Pulmonary function testing. (Procedure)
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.
干预措施: Albuterol inhaler. (Drug)
结局指标
主要结局
Evaluation of macrophage function.
时间窗: 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.
次要结局
- Evaluation of lung function.(On average, within 30 days from the time the testing is completed.)
- Comparison of the amount of an inflammatory marker in the blood, called C-reactive protein.(On average, within 30 days from the time the blood is collected.)
- Comparison of the amount of alpha-1 antitrypsin in the blood.(On average, within 30 days from the time the blood was collected.)