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NCT04328883 · ClinicalTrials.gov registry record · Phase 1
Pharmacodynamics and Pharmacokinetics of Aspirin Inhalation Powder With Non-Enteric-Coated Chewable Aspirin
A Phase 1 study, sponsored by Inova Health Care Services.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT04328883: Completed Phase 1 study, sponsored by Inova Health Care Services.
NCT04328883 is a Phase 1 study that has completed, run by Inova Health Care Services. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04328883, a Phase 1 study, has completed, sponsored by Inova Health Care Services.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
ASA inhalation powder is an inhaled nonsteroidal anti-inflammatory drug-device combination that has been developed to reduce the risk of vascular mortality in patients with suspected acute myocardial infarction (MI), an FDA approved indication for oral formulations of aspirin. The primary goal of study OTP-P0-926 is to collect pharmacokinetic (PK)and pharmacodynamics (PD) pilot data to determine onset and extent of aspirin response after administration of varying doses of inhaled ASA (50-100mg) and 162 mg Non-Enteric-Coated Chewable ASA. PD will be assessed using standard methods to measure platelet inhibition by aspirin including platelet aggregation, serum thromboxane,and urinary thromboxane. Furthermore, the pharmacokinetics (PK) of ASA will be determined and compared to PD measurements. Results of this pilot study will guide dosing in a subsequent larger Phase II study.
Primary Outcome
Change from pre-dose in 1mM arachidonic-induced platelet aggregations at 2, 5, 10, 20,30, 40 minutes and 1,4, and 24hours after dosing with 50, 100mg aspirin dry powder inhalation and 162mg chewed non-enteric coated aspirin.
Interventions
- DRUG Aspirin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2019-07-16 |
| Est. Completion | 2019-10-10 |
| Phase | Phase 1 |
What the finished NCT04328883 record still lists
NCT04328883 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 1 intervention - of which Aspirin is the first listed.
NCT04328883 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04328883 about?
NCT04328883 is a clinical study titled "Pharmacodynamics and Pharmacokinetics of Aspirin Inhalation Powder With Non-Enteric-Coated Chewable Aspirin". ASA inhalation powder is an inhaled nonsteroidal anti-inflammatory drug-device combination that has been developed to reduce the risk of vascular mortality in patients with suspected acute myocardial infarction (MI), an FDA approved indication for oral formulations of aspirin. The primary goal of s...
What is the current status of trial NCT04328883?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2019-07-16. Estimated completion is 2019-10-10.
What interventions are being tested in trial NCT04328883?
The interventions under investigation include: Aspirin (DRUG).
Who is sponsoring clinical trial NCT04328883?
This trial is sponsored by Inova Health Care Services, which has 75 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04328883's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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