Recruiting
Phase 3

Aspirin

Sponsor:

Johns Hopkins University

Code:

NCT05265299

Conditions

Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Aspirin 81mg

Aspirin 162 mg

Aspirin 325mg

Study Details

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Study ID

NCT05265299

Start date

May 16, 2023

Status verified date

Mar, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥40 years
  • Former smoker
  • At least 10 pack-year smoking history
  • Post-bronchodilator ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) < 0.7

Exclusion Criteria:

  • History of myocardial infarction, percutaneous coronary intervention, or stroke
  • Currently taking antiplatelet therapy (other than aspirin 81mg) or anticoagulant medication
  • Contraindication to aspirin (including low platelet count, hematocrit <25%, known aspirin-exacerbated respiratory disease, bleeding disorder, history of bleeding or gastrointestinal (GI) ulcer, coagulopathy, or major surgery within 6 weeks before randomization)
  • Oral corticosteroids within the past 6 weeks
  • Currently taking immunosuppressant medication
  • Active malignancy (other than non-melanoma skin cancer)
  • Uncontrolled hypertension
  • Pregnant or planning pregnancy in the next year
  • Plans to move residence away from the immediate area within the next 3 months

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Aspirin 81mg

Aspirin 81mg once daily

Aspirin 162 mg

Aspirin 162 mg once daily

Aspirin 325mg

Aspirin 325mg once daily

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Wendy Lorizio, MD, MPH

410-510-2449wlorizi1@jhmi.edu

Locations

Johns Hopkins Bayview Medical Center

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Wendy Lorizio, MD, MPH

410-510-2449wlorizi1@jhmi.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Mar 16, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-03-16.