NCT05265299RecruitingPhase 3
Trial to Determine Effective Aspirin Dose in COPD
Randomized Trial to Determine Effective Aspirin Dose in COPD
Source: ClinicalTrials.gov · Last updated 16 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- First submitted
- 22 Feb 2022
- Start date
- May 2023
- Primary completion date
- Dec 2026
- Lead sponsor
- Johns Hopkins University
- Diseases
- COPD
- NCT number
- NCT05265299
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 48
- From May 2023 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently taking antiplatelet therapy (other than aspirin 81mg) or anticoagulant medication
- Oral corticosteroids within the past 6 weeks
- Currently taking immunosuppressant medication
Other illness
- History of myocardial infarction, percutaneous coronary intervention, or stroke
- Active malignancy (other than non-melanoma skin cancer)
- Uncontrolled hypertension
Lab values
- 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)
Other
- Pregnant or planning pregnancy in the next year
- Plans to move residence away from the immediate area within the next 3 months
Who the study is looking for
- 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
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins Bayview Medical Center Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.