A Study of Inhaled Atropine Sulfate in Healthy Adults

August 10, 2010 updated by: MicroDose Defense Products L.L.C.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Montefiore Hospital Clinical and Translational Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Multiple plasma samples collected up to 12 hours post dose

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
up to 36 days (including 14 day screening period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MicroDose Defense Products L.L.C.

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

July 22, 2009

First Submitted That Met QC Criteria

July 27, 2009

First Posted (Estimate)

July 28, 2009

Study Record Updates

Last Update Posted (Estimate)

August 12, 2010

Last Update Submitted That Met QC Criteria

August 10, 2010

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO07030057

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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