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A Study of Inhaled Atropine Sulfate in Healthy Adults

Primary Purpose

Organophosphorus Poisoning

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
atropine sulfate
atropine sulfate
Sponsored by
MicroDose Defense Products L.L.C.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Organophosphorus Poisoning focused on measuring Atropine, Aerosol, Inhaler, Dry Powder

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Montefiore Hospital Clinical and Translational Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Atropine Dry Powder Inhaler

Atropen Autoinjector

Arm Description

Outcomes

Primary Outcome Measures

To characterize pharmacokinetic endpoints for atropine dry powder inhalation (Cmax, Tmax, AUC) and compare these to intramuscular pharmacokinetics (Atropen autoinjector)

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).

Full Information

First Posted
July 22, 2009
Last Updated
August 10, 2010
Sponsor
MicroDose Defense Products L.L.C.
Collaborators
University of Pittsburgh, U.S. Army Space and Missile Defense Command
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1. Study Identification

Unique Protocol Identification Number
NCT00947596
Brief Title
A Study of Inhaled Atropine Sulfate in Healthy Adults
Official Title
Development of an Inhaled, Dry Powder Delivery System for the Administration of Atropine Sulfate
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
MicroDose Defense Products L.L.C.
Collaborators
University of Pittsburgh, U.S. Army Space and Missile Defense Command

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Organophosphorus Poisoning
Keywords
Atropine, Aerosol, Inhaler, Dry Powder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Atropine Dry Powder Inhaler
Arm Type
Experimental
Arm Title
Atropen Autoinjector
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
atropine sulfate
Other Intervention Name(s)
MicroDose inhaler
Intervention Description
dry powder for inhalation
Intervention Type
Drug
Intervention Name(s)
atropine sulfate
Intervention Description
intramuscular injection
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Donahoe, M.D.
Organizational Affiliation
Division of Pulmonary, Allergy and Critical Care Medicine, University of Pittsburgh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Timothy Corcoran, Ph.D.
Organizational Affiliation
Division of Pulmonary, Allergy and Critical Care Medicine, University of Pittsburgh
Official's Role
Study Director
Facility Information:
Facility Name
Montefiore Hospital Clinical and Translational Research Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Links:
URL
http://mdtx.com/pipeline/proprietary-products/atropine/
Description
Product Description

Learn more about this trial

A Study of Inhaled Atropine Sulfate in Healthy Adults

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