Randomized Trial to Determine Effective Aspirin Dose in COPD

Who is this study for? Patients with Chronic Obstructive Pulmonary Disease
What treatments are being studied? Aspirin
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
United States
Maryland
Johns Hopkins Bayview Medical Center
RECRUITING
Baltimore
Contact Information
Primary
Wendy Lorizio, MD, MPH
wlorizi1@jhmi.edu
410-510-2449
Time Frame
Start Date: 2023-05-16
Estimated Completion Date: 2026-12
Participants
Target number of participants: 48
Treatments
Experimental: Sequence 1
* Week 1-2: aspirin 81mg~* Week 5-6: aspirin 162mg~* Week 9-10: aspirin 325mg
Experimental: Sequence 2
* Week 1-2: aspirin 162mg~* Week 5-6: aspirin 81mg~* Week 9-10: aspirin 325mg
Experimental: Sequence 3
* Week 1-2: aspirin 325mg~* Week 5-6: aspirin 81mg~* Week 9-10: aspirin 162mg
Experimental: Sequence 4
* Week 1-2: aspirin 325mg~* Week 5-6: aspirin 162mg~* Week 9-10: aspirin 81mg
Experimental: Sequence 5
* Week 1-2: aspirin 162mg~* Week 5-6: aspirin 325mg~* Week 9-10: aspirin 81mg
Experimental: Sequence 6
* Week 1-2: aspirin 81mg~* Week 5-6: aspirin 325mg~* Week 9-10: aspirin 162mg
Sponsors
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov