Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_3

Timeline

7mo left

Started May 2023

Typical duration for phase_3

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3.5 years study duration

Study Progress84%

May 2023Dec 2026

First Submitted

Initial submission to the registry

February 22, 2022

Completed

9 days until next milestone

First Posted

Study publicly available on registry

March 3, 2022

Completed

1.2 years until next milestone

Study Start

First participant enrolled

May 16, 2023

Completed

3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

3.5 years

First QC Date

February 22, 2022

Last Update Submit

March 13, 2026

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (2)

Change in urinary 11-dehydro-thromboxane B2 level
Urine 11-dehydro-thromboxane B2 level (pg/mg Creatinine) - a urinary metabolite of thromboxane A2.
Baseline, week 2, week 6, week 10
Change in serum thromboxane B2 level
Serum thromboxane B2
Baseline, week 2, week 6, week 10

Secondary Outcomes (4)

Change in proportion of platelets displaying CD62P
Baseline, 2 weeks, 6 weeks, 10 weeks
Change in proportion of platelets displaying CD63
Baseline, 2 weeks, 6 weeks, 10 weeks
Change in proportion of platelets displaying CD154
Baseline, 2 weeks, 6 weeks, 10 weeks
Change in proportion of platelets displaying PAC1
Baseline, 2 weeks, 6 weeks, 10 weeks