A Study of Inhaled Atropine Sulfate in Healthy Adults

This study has been completed.
Sponsor:
Collaborators:
University of Pittsburgh
U.S. Army Space and Missile Defense Command, Chemical Biological Medical Systems
Information provided by:
MicroDose Defense Products L.L.C.
ClinicalTrials.gov Identifier:
NCT00947596
First received: July 22, 2009
Last updated: August 10, 2010
Last verified: August 2009
  Purpose

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 Intervention Phase
Organophosphorus Poisoning
Drug: atropine sulfate
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Development of an Inhaled, Dry Powder Delivery System for the Administration of Atropine Sulfate

Resource links provided by NLM:


Further study details as provided by MicroDose Defense Products L.L.C.:

Primary Outcome Measures:
  • To characterize pharmacokinetic endpoints for atropine dry powder inhalation (Cmax, Tmax, AUC) and compare these to intramuscular pharmacokinetics (Atropen autoinjector) [ Time Frame: Multiple plasma samples collected up to 12 hours post dose ] [ Designated as safety issue: No ]

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). [ Time Frame: up to 36 days (including 14 day screening period) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 18
Study Start Date: August 2009
Study Completion Date: August 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atropine Dry Powder Inhaler Drug: atropine sulfate
dry powder for inhalation
Other Name: MicroDose inhaler
Active Comparator: Atropen Autoinjector Drug: atropine sulfate
intramuscular injection

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 > 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00947596

Locations
United States, Pennsylvania
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, Chemical Biological Medical Systems
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
  More Information

Additional Information:
No publications provided

Responsible Party: Michael Donahoe, MD, University of Pittsburgh Medical Center
ClinicalTrials.gov Identifier: NCT00947596     History of Changes
Other Study ID Numbers: PRO07030057
Study First Received: July 22, 2009
Last Updated: August 10, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by MicroDose Defense Products L.L.C.:
Atropine
Aerosol
Inhaler
Dry Powder

Additional relevant MeSH terms:
Poisoning
Organophosphate Poisoning
Chemically-Induced Disorders
Atropine
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Arrhythmia Agents
Cardiovascular Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014