A Study of Inhaled Atropine Sulfate in Healthy Adults
This study has been completed.
Sponsor:
MicroDose Defense Products L.L.C.
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
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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
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 Substance-Related 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 May 22, 2013