Determining the best aspirin dose for COPD patients
Official title: Randomized Trial to Determine Effective Aspirin Dose in COPD
Run by Johns Hopkins University · NCT05265299 · Data updated 2026-11-12
This study is testing whether different doses of aspirin can help people with COPD breathe better and feel more comfortable.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Enrollment | 48 (estimated) |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Status | Recruiting |
| Started | May 16, 2023 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | March 16, 2026 |
| Trial ID | NCT05265299 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 40 and older with a history of smoking and diagnosed with COPD.
✕Probably not a fit
Patients with a history of cardiovascular events, those currently on antiplatelet therapy, or individuals with contraindications to aspirin will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial aims to evaluate the effectiveness of different doses of aspirin in improving respiratory symptoms in individuals with chronic obstructive pulmonary disease (COPD). Participants will be randomly assigned to receive one of three doses of aspirin (81mg, 162mg, or 325mg) in a crossover design, allowing each participant to experience all treatment doses with a washout period in between. The study will monitor medication adherence and collect blood and urine samples to assess the impact of aspirin on respiratory health. Follow-up visits will occur at two, six, and ten weeks post-randomization to gather comprehensive data on outcomes.
Why it matters
Potential benefit: If successful, this study could lead to improved respiratory health and reduced symptoms for COPD patients through optimized aspirin dosing.
How similar studies have gone: Previous studies have indicated that aspirin may improve respiratory symptoms in COPD, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States Recruiting
Study contacts
- Principal investigator: Ashraf Fawzy, MD, MPH — Johns Hopkins University
- Study coordinator: Wendy Lorizio, MD, MPH
- Email: wlorizi1@jhmi.edu
- Phone: 410-510-2449
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.