A Study of Inhaled Atropine Sulfate in Healthy Adults

NCT00947596 | Completed Phase 1 DMC

• 1 other identifier: PRO07030057
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Organophosphorus Poisoning

Keywords

Atropine; Aerosol; Inhaler; Dry Powder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Study Arms (2)

Atropine Dry Powder Inhaler

EXPERIMENTAL

Drug: atropine sulfate

Atropen Autoinjector

ACTIVE COMPARATOR

Drug: atropine sulfate

Interventions

atropine sulfate DRUG

dry powder for inhalation

Also known as: MicroDose inhaler

Atropine Dry Powder Inhaler

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Montefiore Hospital Clinical and Translational Research Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Links

• Product Description

MeSH Terms

Conditions

Organophosphate Poisoning

Interventions

Atropine

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Michael Donahoe, M.D.

  Division of Pulmonary, Allergy and Critical Care Medicine, University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Timothy Corcoran, Ph.D.

  Division of Pulmonary, Allergy and Critical Care Medicine, University of Pittsburgh

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 22, 2009
• First Posted: July 28, 2009
• Study Start: August 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: August 1, 2010
• Last Updated: August 12, 2010

Record last verified: 2009-08

Locations

US (1)