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Trial to Determine Effective Aspirin Dose in COPD

Randomized Trial to Determine Effective Aspirin Dose in COPD

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Urine samples, Pills, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Study drug will be provided by the Johns Hopkins Research Pharmacy and participants instructed to take one pill once per day at the same time."
  • "Blood and urine samples will be collected at each visit."
  • "Respiratory symptom and quality of life questionnaires 2."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests which daily aspirin dose best blocks the activity of platelets, small blood cells that help blood clot. It is for adults age 40 or older with COPD, a lung disease that makes breathing hard, who used to smoke. Researchers will also study blood and urine tests to learn how people respond to aspirin.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 40 or older.
  • Used to smoke but have quit.
  • Smoked at least 10 pack-years, such as 1 pack a day for 10 years.
  • A breathing test after medicine to open the airways shows an FEV1/FVC ratio below 0.7. This compares the air you blow out in the first second with the total air you blow out.

Who can't join

  • Have had a heart attack, stroke, or a procedure to open a blocked heart artery.
  • Take medicine that blocks platelets, other than aspirin 81 mg, or take other blood-thinning medicine.
  • Cannot safely take aspirin because of low platelets, a low red blood cell level (hematocrit below 25%), breathing problems caused by aspirin, a bleeding or clotting disorder, past bleeding, a stomach or intestinal ulcer, or major surgery within 6 weeks before study group assignment.
  • Took steroid medicine by mouth in the past 6 weeks, or currently take medicine that weakens the immune system.
  • Have active cancer, except non-melanoma skin cancer.
  • Have high blood pressure that is not controlled.
  • Are pregnant or plan to become pregnant in the next year.
  • Plan to move away from the local area within the next 3 months.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

MD