A Study of Inhaled Atropine Sulfate in Healthy Adults

Sponsor

MicroDose Defense Products L.L.C. (Industry)

Overall Status

Completed

CT.gov ID

NCT00947596

Collaborator

University of Pittsburgh (Other), U.S. Army Space and Missile Defense Command (U.S. Fed)

Enrollment

Location

Arms

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

MicroDose Defense Products, LLC is developing an atropine dry powder inhaler (ADPI). This pilot study compares the pharmacokinetics (PK) of inhaled dry powder atropine as delivered by the ADPI to atropine delivery from the AtroPen autoinjector.

Condition or Disease	Intervention/Treatment	Phase
Organophosphorus Poisoning	Drug: atropine sulfate Drug: atropine sulfate	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Development of an Inhaled, Dry Powder Delivery System for the Administration of Atropine Sulfate

Study Start Date :

Aug 1, 2009

Actual Primary Completion Date :

Jul 1, 2010

Actual Study Completion Date :

Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Atropine Dry Powder Inhaler	Drug: atropine sulfate dry powder for inhalation Other Names: MicroDose inhaler
Active Comparator: Atropen Autoinjector	Drug: atropine sulfate intramuscular injection

Arm

Intervention/Treatment

Experimental: Atropine Dry Powder Inhaler

Drug: atropine sulfate

dry powder for inhalation

Other Names:

MicroDose inhaler

Active Comparator: Atropen Autoinjector

Drug: atropine sulfate

intramuscular injection

Outcome Measures

Primary Outcome Measures

To characterize pharmacokinetic endpoints for atropine dry powder inhalation (Cmax, Tmax, AUC) and compare these to intramuscular pharmacokinetics (Atropen autoinjector) [Multiple plasma samples collected up to 12 hours post dose]

Secondary Outcome Measures

To evaluate the safety and tolerability of atropine dry powder inhalation (Clinical Labs testing, Pulse, Pulse Oximetry, Temperature, Heart Rate, Pulmonary Function Tests, Respiratory Rate, Near Point of Accommodation, Pupil Size). [up to 36 days (including 14 day screening period)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Subjects will be 18-55 years of age.
Subjects will be able to read and comprehend the English language.

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

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Montefiore Hospital Clinical and Translational Research Center	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

MicroDose Defense Products L.L.C.
University of Pittsburgh
U.S. Army Space and Missile Defense Command

Investigators

Principal Investigator: Michael Donahoe, M.D., Division of Pulmonary, Allergy and Critical Care Medicine, University of Pittsburgh
Study Director: Timothy Corcoran, Ph.D., Division of Pulmonary, Allergy and Critical Care Medicine, University of Pittsburgh