No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
40 – 80
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
48 (estimated)
Sponsor
Johns Hopkins University · Other
Who this trial is looking for
This trial is looking for former smokers aged 40 and older who have been diagnosed with chronic obstructive pulmonary disease (COPD). Participants will take aspirin to see if it helps improve breathing symptoms and reduce flare-ups.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 40 years old
I am a former smoker
I have a history of smoking for at least 10 years
I have been diagnosed with COPD
You may not be able to join if
I have had a heart attack or stroke
I am currently taking any antiplatelet drugs or blood thinners
I have a medical reason that prevents me from taking aspirin
I have used oral steroids in the last 6 weeks
I am taking immunosuppressant medications
I have an active cancer diagnosis
I have high blood pressure that is not under control
I am pregnant or planning to become pregnant within the next year
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
Trial Locations
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Status
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…
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
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