RecruitingPhase 3NCT05265299

Trial to Determine Effective Aspirin Dose in COPD

Randomized Trial to Determine Effective Aspirin Dose in COPD


Sponsor

Johns Hopkins University

Enrollment

48 participants

Start Date

May 16, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 40 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing different doses of aspirin in people with COPD (chronic obstructive pulmonary disease) to find the most effective dose at reducing inflammation and protecting the lungs, while minimizing side effects. Aspirin has shown promise in reducing lung flare-ups, but the ideal dose is unknown. **You may be eligible if...** - You are 40 years or older - You are a former smoker with at least a 10 pack-year smoking history (e.g., 1 pack/day for 10 years) - You have been diagnosed with COPD (confirmed by a breathing test showing FEV1/FVC below 0.7) **You may NOT be eligible if...** - You have had a heart attack, stroke, or coronary procedure in the past - You are currently taking blood thinners or antiplatelet drugs (other than 81 mg aspirin) - You have a bleeding disorder, stomach ulcer, or are allergic to aspirin - You have taken oral steroids in the past 6 weeks - You are currently on immunosuppressant medications - You have active cancer (other than non-melanoma skin cancer) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAspirin 81mg

Aspirin 81mg once daily

DRUGAspirin 162 mg

Aspirin 162 mg once daily

DRUGAspirin 325mg

Aspirin 325mg once daily


Locations(1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

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NCT05265299


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