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

July 22, 2009
August 10, 2010
August 2009
July 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00947596 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
A Study of Inhaled Atropine Sulfate in Healthy Adults
Development of an Inhaled, Dry Powder Delivery System for the Administration of Atropine Sulfate

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Organophosphorus Poisoning
  • Drug: atropine sulfate
    dry powder for inhalation
    Other Name: MicroDose inhaler
  • Drug: atropine sulfate
    intramuscular injection
  • Experimental: Atropine Dry Powder Inhaler
    Intervention: Drug: atropine sulfate
  • Active Comparator: Atropen Autoinjector
    Intervention: Drug: atropine sulfate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
August 2010
July 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00947596
PRO07030057
Yes
Michael Donahoe, MD, University of Pittsburgh Medical Center
MicroDose Defense Products L.L.C.
  • University of Pittsburgh
  • U.S. Army Space and Missile Defense Command, Chemical Biological Medical Systems
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
MicroDose Defense Products L.L.C.
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP