Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 40 to 80

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

PhasePhase 3
Study typeInterventional
Ages40 Years to 80 Years
SexAll
Enrollment48 (estimated)
SponsorJohns Hopkins University
Academic / other
Locations1 site (Baltimore, Maryland)
StatusRecruiting
StartedMay 16, 2023
Main results expectedDecember 2026
Study endsDecember 2026
Registry record updatedMarch 16, 2026
Trial IDNCT05265299 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.