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Antiplatelet Agent
Aspirin Dosing for COPD
Phase 3
Recruiting
Led By Ashraf Fawzy, MD, MPH
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥40 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 2, week 6, week 10
Awards & highlights
Study Summary
This trial looks at how taking aspirin may help people with COPD by blocking platelet activation, which can lead to fewer COPD flare-ups & lower mortality.
Who is the study for?
This trial is for individuals over 40 years old with a history of smoking and diagnosed COPD, indicated by specific lung function tests. It's not suitable for those who've had recent heart problems or strokes, are pregnant or planning to be, have certain heart findings on CT scans, bleeding disorders, uncontrolled high blood pressure, or are on immunosuppressants.Check my eligibility
What is being tested?
The study aims to find the best aspirin dose (81mg, 162mg, or 325mg) for reducing platelet activation in COPD patients without cardiovascular disease. This could lead to fewer respiratory symptoms and flares. The results will help design larger trials focused on clinical outcomes.See study design
What are the potential side effects?
Aspirin may cause side effects like gastrointestinal issues such as stomach pain and ulcers; bleeding problems; allergic reactions including breathing difficulties if one has an aspirin allergy; and possibly increased bruising due to its blood-thinning properties.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 40 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 2, week 6, week 10
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 2, week 6, week 10
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in serum thromboxane B2 level
Change in urinary 11-dehydro-thromboxane B2 level
Secondary outcome measures
Change in proportion of platelets displaying CD154
Change in proportion of platelets displaying CD62P
Change in proportion of platelets displaying CD63
+1 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: Sequence 6Experimental Treatment3 Interventions
Week 1-2: aspirin 81mg
Week 5-6: aspirin 325mg
Week 9-10: aspirin 162mg
Group II: Sequence 5Experimental Treatment3 Interventions
Week 1-2: aspirin 162mg
Week 5-6: aspirin 325mg
Week 9-10: aspirin 81mg
Group III: Sequence 4Experimental Treatment3 Interventions
Week 1-2: aspirin 325mg
Week 5-6: aspirin 162mg
Week 9-10: aspirin 81mg
Group IV: Sequence 3Experimental Treatment3 Interventions
Week 1-2: aspirin 325mg
Week 5-6: aspirin 81mg
Week 9-10: aspirin 162mg
Group V: Sequence 2Experimental Treatment3 Interventions
Week 1-2: aspirin 162mg
Week 5-6: aspirin 81mg
Week 9-10: aspirin 325mg
Group VI: Sequence 1Experimental Treatment3 Interventions
Week 1-2: aspirin 81mg
Week 5-6: aspirin 162mg
Week 9-10: aspirin 325mg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetylsalicylic acid
FDA approved
Acetylsalicylic acid
FDA approved
Find a Location
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,266 Previous Clinical Trials
14,837,449 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,840 Previous Clinical Trials
47,852,076 Total Patients Enrolled
Ashraf Fawzy, MD, MPHPrincipal InvestigatorJohns Hopkins University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an active cancer other than non-melanoma skin cancer.I cannot take aspirin due to a health condition or recent major surgery.Your breathing test shows that you have trouble exhaling air from your lungs.I am currently on medication to prevent blood clots.I am 40 years old or older.I am currently on medication that suppresses my immune system.You are planning to move away from the area within the next 3 months.You have smoked the equivalent of at least 10 packs of cigarettes per year for multiple years.I have had a heart attack, stroke, or a procedure to open my heart's arteries.You used to smoke cigarettes.You have signs of calcium buildup in your heart's blood vessels on a CT scan.My blood pressure is not controlled by medication.I have not taken oral corticosteroids in the last 6 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Sequence 4
- Group 2: Sequence 1
- Group 3: Sequence 2
- Group 4: Sequence 6
- Group 5: Sequence 3
- Group 6: Sequence 5
Awards:
This trial has 4 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What level of hazard might individuals face when exposed to Sequence 5?
"Our analysts at Power have awarded Sequence 5 a score of 3 as it has reached Phase 3 and there is ample evidence supporting its efficacy and safety."
Answered by AI
Are there any openings remaining for those seeking to join this experiment?
"As per the clinicaltrials.gov listing, this trial is currently enrolling patients. First posted on May 16th 2023 and last updated on the same day, it seeks volunteers to participate in its research."
Answered by AI
How many volunteers have agreed to take part in this trial?
"Correct. According to clinicaltrials.gov, this research project is actively enrolling individuals after first being posted on May 16th 2023 and lastly updated on the same date. The study seeks 48 participants from a single site location."
Answered by AI
What is the main purpose of this experimental research?
"This clinical trial's primary objective is to track the alteration of serum thromboxane B2 levels over a period spanning from Baseline to Week 10. Secondary endpoints involve assessing the proportion of platelets displaying CD63, CD154 and PAC1 following stimulation with U46619, a thromboxane A2 agonist."
Answered by AI
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