NCT05265299 Trial to Determine Effective Aspirin Dose in COPD
| NCT ID | NCT05265299 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Johns Hopkins University |
| Condition | Pulmonary Disease, Chronic Obstructive |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2023-05-16 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 48 participants in total. It began in 2023-05-16 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Ashraf Fawzy, MD, MPH
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT05265299 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 80 Years, studying Pulmonary Disease, Chronic Obstructive. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05265299 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 48 participants.
Is NCT05265299 currently recruiting?
Yes, NCT05265299 is actively recruiting participants. Contact the research team at wlorizi1@jhmi.edu for enrollment information.
Where is the NCT05265299 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT05265299 clinical trial?
NCT05265299 is sponsored by Johns Hopkins University. The principal investigator is Ashraf Fawzy, MD, MPH at Johns Hopkins University. The trial plans to enroll 48 participants.