Trial to Determine Effective Aspirin Dose in COPD

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT05265299
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Aspirin 81mg — DRUG
    Aspirin 81mg once daily
  • Aspirin 162 mg — DRUG
    Aspirin 162 mg once daily
  • Aspirin 325mg — DRUG
    Aspirin 325mg once daily

Study Details

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.

Key Dates

Start date
May 16, 2023
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Sequence 1
    * Week 1-2: aspirin 81mg * Week 5-6: aspirin 162mg * Week 9-10: aspirin 325mg
  • Experimental: Sequence 2
    * Week 1-2: aspirin 162mg * Week 5-6: aspirin 81mg * Week 9-10: aspirin 325mg
  • Experimental: Sequence 3
    * Week 1-2: aspirin 325mg * Week 5-6: aspirin 81mg * Week 9-10: aspirin 162mg
  • Experimental: Sequence 4
    * Week 1-2: aspirin 325mg * Week 5-6: aspirin 162mg * Week 9-10: aspirin 81mg
  • Experimental: Sequence 5
    * Week 1-2: aspirin 162mg * Week 5-6: aspirin 325mg * Week 9-10: aspirin 81mg
  • Experimental: Sequence 6
    * Week 1-2: aspirin 81mg * Week 5-6: aspirin 325mg * Week 9-10: aspirin 162mg

Primary Outcome Measure

Change in urinary 11-dehydro-thromboxane B2 level [ Time Frame: Baseline, week 2, week 6, week 10 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins Bayview Medical CenterBaltimoreMaryland21224
Wendy Lorizio, MD, MPH
[email protected]
410-510-2449

Find similar trials in Baltimore, MD

By condition
COPD
By specialty
PulmonologyLung disease
By research site
Johns Hopkins Bayview Medical Center· Baltimore, MD

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