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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
Must not have
Active malignancy (other than non-melanoma skin cancer)
Currently taking antiplatelet therapy or anticoagulant medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 2, week 6, week 10
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Pivotal Trial

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.
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.
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 below
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I am 40 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an active cancer other than non-melanoma skin cancer.
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I am currently on medication to prevent blood clots.
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I am currently on medication that suppresses my immune system.
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I have had a heart attack, stroke, or a procedure to open my heart's arteries.
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My blood pressure is not controlled by medication.
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I have not taken oral corticosteroids in the last 6 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 2, week 6, week 10
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 2, week 6, week 10 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in serum thromboxane B2 level
Change in urinary 11-dehydro-thromboxane B2 level
Secondary study objectives
Change in proportion of platelets displaying CD154
Change in proportion of platelets displaying CD62P
Change in proportion of platelets displaying CD63
+1 more

Awards & Highlights

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.

Trial 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
2,326 Previous Clinical Trials
14,874,952 Total Patients Enrolled
35 Trials studying Asthma
82,551 Patients Enrolled for Asthma
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,933 Previous Clinical Trials
47,790,988 Total Patients Enrolled
283 Trials studying Asthma
114,628 Patients Enrolled for Asthma
Ashraf Fawzy, MD, MPHPrincipal InvestigatorJohns Hopkins University

Media Library

Aspirin 162 mg (Antiplatelet Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05265299 — Phase 3
Asthma Research Study Groups: Sequence 4, Sequence 1, Sequence 2, Sequence 6, Sequence 3, Sequence 5
Asthma Clinical Trial 2023: Aspirin 162 mg Highlights & Side Effects. Trial Name: NCT05265299 — Phase 3
Aspirin 162 mg (Antiplatelet Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05265299 — Phase 3
~27 spots leftby Dec 2026
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