This is a pilot study looking at asthmatics and non-asthmatics with different BMIs. Participants will undergo a baseline evaluation, lung function testing, and a subsequent bronchoscopy and nasal epithelial brush smapling in those that meet study enrollment.More
a. Adequate completion of informed consent process with written documentation b. Male and female patients, ≥ 18 - 65 years old c. Smoking history <10 pack years and no smoking in the last year
1. For ALL Groups a. Adequate completion of informed consent process with written documentation b. Male and female patients, ≥ 18 - 65 years old c. Smoking history <10 pack years and no smoking in the last year **Subjects can be included in the study if they are on blood pressure treatment and are on a diet control/exercise only treatment of diabetes. d. Specific to Asthma Groups i. From all racial/ethnic backgrounds with a diagnosis of asthma based on physician diagnosis for >6 months ii. Baseline pre-bronchodilator FEV1 of 50% or greater of predicted with a 12% or greater bronchodilator response to 4 puffs of albuterol or PC20 methacholine (16 mg) if no BD response; Documented historical bronchodilator response on pre/post spirometry or positive methacholine up to 24 months acceptable for inclusion. 1. Specific to Metabolic Syndrome Group. Metabolic syndrome diagnosis based on having at least any three of: a. Triglycerides ≥ 150 mg/dl; b. HDL cholesterol ≤ 50 mg/dl for women and ≤ 40 mg/dl for men; c. Fasting blood glucose ≥ 100 mg/dl; d. Waist circumference > 40 inches males and > 35 inches females); e. Previously diagnosed hypertension or on antihypertensive medication; f. Blood pressure greater than 130/85 on two consecutive measurements. 2. Specific to Non-Metabolic Syndrome Group a. BMI ≥ 30 b. No more than two of the metabolic syndrome parameters Metabolic syndrome diagnosis based on having at least any three of: i. Triglycerides ≥ 150 mg/dl; ii. HDL cholesterol ≤ 50 mg/dl for women and ≤ 40 mg/dl for men; iii. Fasting blood glucose ≥ 100 mg/dl; iv. Waist circumference > 40 inches males and > 35 inches females); v. Previously diagnosed hypertension or on antihypertensive medication; vi. Blood pressure greater than 130/85 on two consecutive measurements. 3. Specific to Non-Obese Group a. BMI < 30 e. Specific to Obese, Non-Asthma Group i. No history of asthma or any other airway diseases; ii. Pulmonary function test within normal limits; iii. BMI ≥ 30. f. Specific to Non-Obese, Non-Asthma Group i. No history of asthma or any other airway diseases; ii. Pulmonary function test within normal limits; iii. BMI < 30 Exclusion Criteria: 1. Exclusion Criteria for ALL Groups 1. Significant or uncontrolled concomitant medical illness (PI discretion) including, but not limited to: a. heart disease b. cancer c. autoimmune disease d. diabetes (HbAc1 > 6.5) e. renal disease (creatinine > 2.0) at Visit 0 f. neurological (brain damage) g. psychiatric disorder (diagnosed by a mental health professional of behavioral or mental pattern that may cause suffering or a poor ability to function in life); 2. Chronic renal failure (serum creatinine > 2.0) at screening (associated with higher ADMA levels); 3. Current statins use (statins lower ADMA levels); 4. On diabetic medications; 5. Positive pregnancy test; 6. Positive urine cotinine and/or urine THC test; 7. Current or recent (within 30 days) investigational treatment or participation in another interventional research study 8. Unable or unlikely to complete study assessments or the study intervention (i.e. bronchoscopy) poses undue risk to patient in the opinion of the investigator. a. Specific to Asthma Groups i. Respiratory tract infection within the last 4 weeks; ii. Oral or systemic CS burst within the last 4 weeks; iii. Asthma-related hospitalization within the last 2 months; iv. Asthma-related ER visit within the previous 4 weeks.
University of Colorado Hospital
Fernando Holguin, MD
Protocol Number: 16-2522
More information available at ClinicalTrials.gov: NCT03215836
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