Status:
RECRUITING
Trial to Determine Effective Aspirin Dose in COPD
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40-80 years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
The trial will enroll individuals with chronic obstructive pulmonary disease (COPD). The primary design will be a randomized double-blind 6-sequence, 3-period, 3-treatment sequential crossover trial f...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT05265299
Start Date
May 16 2023
End Date
December 1 2026
Last Update
March 14 2025
Active Locations (1)
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1
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224