RECRUITING

Trial to Determine Effective Aspirin Dose in COPD

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Randomized Trial to Determine Effective Aspirin Dose in COPD

Quick Facts

Study Start:2023-05-16
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05265299

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥40 years
  2. * Former smoker
  3. * At least 10 pack-year smoking history
  4. * Post-bronchodilator ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) \< 0.7
  1. * History of myocardial infarction, percutaneous coronary intervention, or stroke
  2. * Presence of coronary artery calcification on computed tomography (CT) scan by visual assessment
  3. * Currently taking antiplatelet therapy or anticoagulant medication
  4. * 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)
  5. * Oral corticosteroids within the past 6 weeks
  6. * Currently taking immunosuppressant medication
  7. * Active malignancy (other than non-melanoma skin cancer)
  8. * Uncontrolled hypertension
  9. * Pregnant or planning pregnancy in the next year
  10. * Plans to move residence away from the immediate area within the next 3 months

Contacts and Locations

Study Contact

Wendy Lorizio, MD, MPH
CONTACT
410-510-2449
wlorizi1@jhmi.edu

Principal Investigator

Ashraf Fawzy, MD, MPH
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Ashraf Fawzy, MD, MPH, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-16
Study Completion Date2026-12

Study Record Updates

Study Start Date2023-05-16
Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

  • Pulmonary Disease, Chronic Obstructive