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NCT05265299 · ClinicalTrials.gov registry record · Phase 3
Trial to Determine Effective Aspirin Dose in COPD
A Phase 3 study of Pulmonary Disease, Chronic Obstructive, sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT05265299 is a Phase 3 study of Pulmonary Disease, Chronic Obstructive that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 48 participants, below the 1,043-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05265299, a Phase 3 study of Pulmonary Disease, Chronic Obstructive, is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death in the United States. Current treatments for COPD focus on inhaler therapies that do not address manifestations of the disease on other organ systems. Platelets, which are small blood cells that typically help with clotting, are also involved in generalized inflammation and dysfunctionality of immune cells when these cells become activated. Activated platelets have long been known to play a role in the development of cardiovascular disease. However, there is recent evidence that activated platelets may be involved in worse respiratory symptoms in COPD independent of cardiovascular disease. Individuals with COPD who are taking aspirin, which is an antiplatelet agent that blocks activation of platelets, have been shown to have improved respiratory symptoms, fewer COPD flares, and lower mortality. The investigators' ultimate goal is to study whether aspirin use improves respiratory symptoms independent of cardiovascular disease. The investigators are conducting the current pilot trial to determine the optimal dose of aspirin that blocks platelet activation in this population and investigate whether there are any blood or urine tests that can help with understanding response to therapy. The results will inform the design of a larger trial investigating clinical outcomes. The investigators hypothesize that daily low-dose aspirin will not be sufficient to adequately suppress platelet activation and that an aspirin dose of at least 162mg daily will be necessary.
Conditions Studied
Interventions
- DRUG Aspirin 325mg
- DRUG Aspirin 162 mg
- DRUG Aspirin 81mg
Study Locations (1)
Maryland
- Johns Hopkins Bayview Medical Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2023-05-16 |
| Est. Completion | 2026-12 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05265299
The ClinicalTrials.gov registry entry for NCT05265299 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,043-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (95% lower). The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pulmonary Disease, Chronic Obstructive appearing as the primary indexed condition, and to 3 interventions - of which Aspirin 325mg is the first listed.
NCT05265299 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT05265299 about?
NCT05265299 is a clinical study titled "Trial to Determine Effective Aspirin Dose in COPD". Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death in the United States. Current treatments for COPD focus on inhaler therapies that do not address manifestations of the disease on other organ systems. Platelets, which are small blood cells that typically help with clo...
What is the current status of trial NCT05265299?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 48 participants. The study started on 2023-05-16. Estimated completion is 2026-12.
What conditions does trial NCT05265299 study?
This clinical trial studies the following conditions: Pulmonary Disease, Chronic Obstructive.
What interventions are being tested in trial NCT05265299?
The interventions under investigation include: Aspirin 325mg (DRUG), Aspirin 162 mg (DRUG), Aspirin 81mg (DRUG).
Who is sponsoring clinical trial NCT05265299?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05265299 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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