Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2009-08-31
2010-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparative Pharmacokinetics and Pharmacodynamics of Tiotropium With Ipratropium or Placebo After 19 Days of Tiotropium Treatment
NCT02172781
Pharmacokinetic Study Comparing Tiotropium Easyhaler and Spiriva Handihaler
NCT03400241
The Safety, Feasibility, and Repeatability of Inhaled ATP Cough Challenges
NCT07085975
Evaluation of Tiotropium 5 µg/Day Delivered Via the Respimat® Inhaler Over 48 Weeks in Patients With Severe Persistent Asthma on Top of Usual Care (Study II)
NCT00776984
Explorative Clinical Investigation to Investigate the Ability of PreciseInhale to Direct Regional Lung Targeting and Reduce the Degree of Throat Deposition and Subsequent Gastrointestinal Absorption in Healthy Volunteers After Inhalation of Test Drug Substances Via the PreciseInhale System
NCT04946630
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Atropine Dry Powder Inhaler
atropine sulfate
dry powder for inhalation
Atropen Autoinjector
atropine sulfate
intramuscular injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
atropine sulfate
dry powder for inhalation
atropine sulfate
intramuscular injection
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subjects will be able to read and comprehend the English language.
Exclusion Criteria
* 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.
18 Years
55 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Pittsburgh
OTHER
U.S. Army Space and Missile Defense Command
FED
MicroDose Defense Products L.L.C.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
University of Pittsburgh Medical Center
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michael Donahoe, M.D.
Role: PRINCIPAL_INVESTIGATOR
Division of Pulmonary, Allergy and Critical Care Medicine, University of Pittsburgh
Timothy Corcoran, Ph.D.
Role: STUDY_DIRECTOR
Division of Pulmonary, Allergy and Critical Care Medicine, University of Pittsburgh
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Montefiore Hospital Clinical and Translational Research Center
Pittsburgh, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Product Description
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PRO07030057
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.