A Study of Inhaled Atropine Sulfate in Healthy Adults

Exclusion Criteria

• •Subjects weighing less than 100 lbs.
• •Women of childbearing potential who are pregnant or unwilling to undergo pregnancy testing; females with positive pregnancy testing on either screening day or any test day will be excluded. Nursing mothers will be excluded
• •Persons unable or unwilling to complete written informed consent (No proxy consent will be obtained).
• •Persons with a past medical history or symptoms of pulmonary disease (including but not limited to: asthma, COPD, Emphysema, Sarcoidosis, Lung Cancer, Pulmonary Embolism, Pulmonary Hypertension))or cardiac disease (coronary artery disease, hypertension, angina, arrhythmias, palpitations, past myocardial infarction history).
• •Persons with a previous history or symptoms of adverse reaction to atropine.
• •Persons with history or symptoms of prostate hypertrophy or prostate cancer.
• •Persons with a history or symptoms of pyloric stenosis.
• •Persons with a history or symptoms of high blood pressure or a diagnosis of cerebral vascular accident (CVA) or transient ischemic attack (TIA).
• •Subjects with a history or symptoms of urological disorders or renal insufficiency.
• •Subjects with a history or symptoms of diabetes.
• •Persons demonstrating increased intraocular pressure, an abnormal optical exam, or history of glaucoma.
• •Persons demonstrating a one second forced expiratory volume (FEV1) or a forced vital capacity (FVC) of less than 70% of predicted either at screening or during pre test exam will be excluded
• •Persons demonstrating any kind of irregular heart rhythm during pre test screening will be excluded. Persons demonstrating any irregular rhythms during testing will be immediately removed.
• •from testing and receive appropriate care and referral from the study physician
• •Persons will be excluded if any two laboratory tests characterizing a specific organ system are more than 10% outside of normal range
• •Subjects with screening day vital signs considered to be beyond normal range will be excluded. This will include BP systolic \> 140, Diastolic \> 90, HR \> 100, RR \> 20, temp \> 38.
• •The study physician will have the discretion to exclude subjects that he/she feels will not be able to safely able to participate in these studies based on review of all screening materials.
• •Self reported tobacco use or positive cotinine testing.
• •Any individuals with positive results on a urine drug screening will be excluded.
• •Persons with an O2 saturation value \< 92%.
• •Persons who have performed other medical studies involving drug delivery in the last 30 days.
• •Blood donation in the last 30 days.
• •Subjects regularly utilizing any of the following medications will be excluded: amantadine, quinidine, phenothiazines, tricyclic antidepressants, digoxin, potassium chloride and potassium citrate formulations, topiramate, zonisamide.
• •Subjects under 18 years of age.