Determining the best aspirin dose for COPD patients
Randomized Trial to Determine Effective Aspirin Dose in COPD
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 |
| Enrollment | 48 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05265299 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40 and older with a history of smoking and diagnosed with COPD.
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.
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 performed: Previous studies have indicated that aspirin may improve respiratory symptoms in COPD, suggesting potential success for this approach.
Eligibility criteria
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 this trial is running
Baltimore, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.