Organophosphorus PoisoningPhase 1NCT00947596
A Study of Inhaled Atropine Sulfate in Healthy Adults
A Phase 1 study testing atropine sulfate in people with Organophosphorus Poisoning, run by MicroDose Defense Products L.L.C. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Organophosphorus Poisoning
- What is being tested?
- atropine sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Aug 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects will be 18-55 years of age.
- Subjects will be able to read and comprehend the English language.
Who cannot join
- 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.
Show all 24Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Hospital Clinical and Translational Research Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: 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.
- Conditions
- Organophosphorus Poisoning
- Being tested
- atropine sulfate
- Keywords
- Atropine, Aerosol, Inhaler, Dry Powder
- Medical subject headings
- Organophosphate Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atropine sulfateDrug
Also called MicroDose inhaler
dry powder for inhalation
atropine sulfateDrug
intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Atropine Dry Powder Inhaler | Experimental | Not described Receives: Drug: atropine sulfate |
| Atropen Autoinjector | Active comparator | Not described Receives: Drug: atropine sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize pharmacokinetic endpoints for atropine dry powder inhalation (Cmax, Tmax, AUC) and compare these to intramuscular pharmacokinetics (Atropen autoinjector)
Measured: 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).
Measured: up to 36 days (including 14 day screening period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionJul 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organophosphorus PoisoningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MicroDose Defense Products L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Pittsburgh, U.S. Army Space and Missile Defense Command
- Investigators
- Michael Donahoe, M.D., Principal investigator, Division of Pulmonary, Allergy and Critical Care Medicine, University of PittsburghTimothy Corcoran, Ph.D., Study director, Division of Pulmonary, Allergy and Critical Care Medicine, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00947596
- Sponsor's protocol ID
- PRO07030057
- Status last verified
- Aug 2009
- First submitted
- 22 Jul 2009
- Last updated
- 12 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Inhaled, Dry Powder Delivery System for the Administration of Atropine Sulfate
- ClinicalTrials.gov ID
- NCT00947596
- Acronym / sponsor ID
- PRO07030057
- Conditions
- Organophosphorus Poisoning
- Keywords
- Atropine, Aerosol, Inhaler, Dry Powder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- MicroDose Defense Products L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- University of Pittsburgh, U.S. Army Space and Missile Defense Command
- Study start
- Aug 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 28 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atropine Dry Powder Inhaler | Experimental | Drug: atropine sulfate |
| Atropen Autoinjector | Active comparator | Drug: atropine sulfate |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subjects will be 18-55 years of age.
- Subjects will be able to read and comprehend the English language.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| atropine sulfateAlso: MicroDose inhalerdry powder for inhalation | Drug | Atropine Dry Powder Inhaler |
| atropine sulfateintramuscular injection | Drug | Atropen Autoinjector |
Primary outcome
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
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2010.
- Product DescriptionLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Donahoe, M.D. principal investigator
Division of Pulmonary, Allergy and Critical Care Medicine, University of Pittsburgh
Timothy Corcoran, Ph.D. study director
Division of Pulmonary, Allergy and Critical Care Medicine, University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing atropine sulfate in people with Organophosphorus Poisoning, run by MicroDose Defense Products L.L.C. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2010.