Pulmonary Disease, Chronic ObstructivePhase 3NCT05265299
Trial to Determine Effective Aspirin Dose in COPD
A Phase 3 study testing Aspirin 81mg, Aspirin 162 mg and Aspirin 325mg in people with Pulmonary Disease, Chronic Obstructive, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Aspirin 81mg, Aspirin 162 mg and Aspirin 325mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2023to Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- Uncontrolled hypertension
- Pregnant or planning pregnancy in the next year
- Plans to move residence away from the immediate area within the next 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
Wendy Lorizio, MD, MPH, 410-510-2449, wlorizi1@jhmi.edu
About this study
Official title: Randomized Trial to Determine Effective Aspirin Dose in COPD
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.
Read 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 for which the investigators will randomize participants to receive 81mg, 162mg, and 325mg aspirin in one of six pre-specified sequences with a 14-day washout period between doses. Participants will have three follow-up visits after randomization.
Individuals who agree to participate in the clinical trial will be randomized to one of six treatment sequences using a computer algorithm at the baseline study visit. Study drug will be provided by the Johns Hopkins Research Pharmacy and participants instructed to take one pill once per day at the same time. All study drug doses will be compounded to appear identical and placed in identical containers fitted with an electronic cap for monitoring medication adherence. Participants will be scheduled to return for a follow-up visit at two weeks, six weeks, and ten weeks after randomization. Blood and urine samples will be collected at each visit. Data will be collected by the principal investigator or trained study coordinator and will be electronically entered into a database stored on the secure Johns Hopkins servers through an online interface that is password protected. Urine will be collected and analyzed for 11-dehydro-thromboxane B2 at each study visit and constitutes the primary outcome of the study. Secondary outcomes will include measurement of platelet reactivity to U46619, a thromboxane A2 agonist, through identification of platelet surface markers CD62P, CD63, CD154 and PAC1.
The following adherence measurements will also be collected:
- Drug discontinuation rate
- Date and time of each dose of study medication obtained through electronic monitoring to assess adherence
The following clinical data will be collected at randomization:
- Spirometry performed before and after administration of albuterol per American Thoracic Society protocol in a certified laboratory
The following clinical data will be collected at randomization and each subsequent study visit:
- Respiratory symptom and quality of life questionnaires
- Occurrence of COPD flares (exacerbations)
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Aspirin 81mg, Aspirin 162 mg, Aspirin 325mg
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin 81mgDrug
Also called Acetylsalicylic acid
Aspirin 81mg once daily
Aspirin 162 mgDrug
Also called Acetylsalicylic acid
Aspirin 162 mg once daily
Aspirin 325mgDrug
Also called Acetylsalicylic acid
Aspirin 325mg once daily
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | * Week 1-2: aspirin 81mg
* Week 5-6: aspirin 162mg
* Week 9-10: aspirin 325mg Receives: Drug: Aspirin 81mg; Drug: Aspirin 162 mg; Drug: Aspirin 325mg |
| Sequence 2 | Experimental | * Week 1-2: aspirin 162mg
* Week 5-6: aspirin 81mg
* Week 9-10: aspirin 325mg Receives: Drug: Aspirin 81mg; Drug: Aspirin 162 mg; Drug: Aspirin 325mg |
| Sequence 3 | Experimental | * Week 1-2: aspirin 325mg
* Week 5-6: aspirin 81mg
* Week 9-10: aspirin 162mg Receives: Drug: Aspirin 81mg; Drug: Aspirin 162 mg; Drug: Aspirin 325mg |
| Sequence 4 | Experimental | * Week 1-2: aspirin 325mg
* Week 5-6: aspirin 162mg
* Week 9-10: aspirin 81mg Receives: Drug: Aspirin 81mg; Drug: Aspirin 162 mg; Drug: Aspirin 325mg |
| Sequence 5 | Experimental | * Week 1-2: aspirin 162mg
* Week 5-6: aspirin 325mg
* Week 9-10: aspirin 81mg Receives: Drug: Aspirin 81mg; Drug: Aspirin 162 mg; Drug: Aspirin 325mg |
| Sequence 6 | Experimental | * Week 1-2: aspirin 81mg
* Week 5-6: aspirin 325mg
* Week 9-10: aspirin 162mg Receives: Drug: Aspirin 81mg; Drug: Aspirin 162 mg; Drug: Aspirin 325mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in urinary 11-dehydro-thromboxane B2 level
Urine 11-dehydro-thromboxane B2 level (pg/mg Creatinine) - a urinary metabolite of thromboxane A2.
Measured: Baseline, week 2, week 6, week 10
Change in serum thromboxane B2 level
Serum thromboxane B2
Measured: Baseline, week 2, week 6, week 10
Secondary outcomes (4)
Change in proportion of platelets displaying CD62P
Proportion of platelets displaying CD62P (activated platelets) following stimulation with U46619, a thromboxane A2 agonist.
Measured: Baseline, 2 weeks, 6 weeks, 10 weeks
Change in proportion of platelets displaying CD63
Proportion of platelets displaying CD63 (activated platelets) following stimulation with U46619, a thromboxane A2 agonist.
Measured: Baseline, 2 weeks, 6 weeks, 10 weeks
Change in proportion of platelets displaying CD154
Proportion of platelets displaying CD154 (activated platelets) following stimulation with U46619, a thromboxane A2 agonist
Measured: Baseline, 2 weeks, 6 weeks, 10 weeks
Change in proportion of platelets displaying PAC1
Proportion of platelets displaying PAC1 (activated platelets) following stimulation with U46619, a thromboxane A2 agonist
Measured: Baseline, 2 weeks, 6 weeks, 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start16 May 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 6-sequence, 3-period, 3-treatment sequential crossover trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Ashraf Fawzy, MD, MPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265299
- Sponsor's protocol ID
- IRB00309828
- Other IDs
- 1K23HL151758-01A1
- Status last verified
- Mar 2026
- First submitted
- 22 Feb 2022
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial to Determine Effective Aspirin Dose in COPD
- ClinicalTrials.gov ID
- NCT05265299
- Acronym / sponsor ID
- IRB00309828
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 16 May 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 for which the investigators will randomize participants to receive 81mg, 162mg, and 325mg aspirin in one of six pre-specified sequences with a 14-day washout period between doses. Participants will have three follow-up visits after randomization.
Individuals who agree to participate in the clinical trial will be randomized to one of six treatment sequences using a computer algorithm at the baseline study visit. Study drug will be provided by the Johns Hopkins Research Pharmacy and participants instructed to take one pill once per day at the same time. All study drug doses will be compounded to appear identical and placed in identical containers fitted with an electronic cap for monitoring medication adherence. Participants will be scheduled to return for a follow-up visit at two weeks, six weeks, and ten weeks after randomization. Blood and urine samples will be collected at each visit. Data will be collected by the principal investigator or trained study coordinator and will be electronically entered into a database stored on the secure Johns Hopkins servers through an online interface that is password protected. Urine will be collected and analyzed for 11-dehydro-thromboxane B2 at each study visit and constitutes the primary outcome of the study. Secondary outcomes will include measurement of platelet reactivity to U46619, a thromboxane A2 agonist, through identification of platelet surface markers CD62P, CD63, CD154 and PAC1.
The following adherence measurements will also be collected:
- Drug discontinuation rate
- Date and time of each dose of study medication obtained through electronic monitoring to assess adherence
The following clinical data will be collected at randomization:
- Spirometry performed before and after administration of albuterol per American Thoracic Society protocol in a certified laboratory
The following clinical data will be collected at randomization and each subsequent study visit:
- Respiratory symptom and quality of life questionnaires
- Occurrence of COPD flares (exacerbations)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- 6-sequence, 3-period, 3-treatment sequential crossover trial
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: Aspirin 81mg, Drug: Aspirin 162 mg, Drug: Aspirin 325mg* Week 1-2: aspirin 81mg * Week 5-6: aspirin 162mg * Week 9-10: aspirin 325mg |
| Sequence 2 | Experimental | Drug: Aspirin 81mg, Drug: Aspirin 162 mg, Drug: Aspirin 325mg* Week 1-2: aspirin 162mg * Week 5-6: aspirin 81mg * Week 9-10: aspirin 325mg |
| Sequence 3 | Experimental | Drug: Aspirin 81mg, Drug: Aspirin 162 mg, Drug: Aspirin 325mg* Week 1-2: aspirin 325mg * Week 5-6: aspirin 81mg * Week 9-10: aspirin 162mg |
| Sequence 4 | Experimental | Drug: Aspirin 81mg, Drug: Aspirin 162 mg, Drug: Aspirin 325mg* Week 1-2: aspirin 325mg * Week 5-6: aspirin 162mg * Week 9-10: aspirin 81mg |
| Sequence 5 | Experimental | Drug: Aspirin 81mg, Drug: Aspirin 162 mg, Drug: Aspirin 325mg* Week 1-2: aspirin 162mg * Week 5-6: aspirin 325mg * Week 9-10: aspirin 81mg |
| Sequence 6 | Experimental | Drug: Aspirin 81mg, Drug: Aspirin 162 mg, Drug: Aspirin 325mg* Week 1-2: aspirin 81mg * Week 5-6: aspirin 325mg * Week 9-10: aspirin 162mg |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin 81mgAlso: Acetylsalicylic acidAspirin 81mg once daily | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| Aspirin 162 mgAlso: Acetylsalicylic acidAspirin 162 mg once daily | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| Aspirin 325mgAlso: Acetylsalicylic acidAspirin 325mg once daily | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
Primary outcome
Change in urinary 11-dehydro-thromboxane B2 level
Time frame: Baseline, week 2, week 6, week 10
Urine 11-dehydro-thromboxane B2 level (pg/mg Creatinine) - a urinary metabolite of thromboxane A2.
Change in serum thromboxane B2 level
Time frame: Baseline, week 2, week 6, week 10
Serum thromboxane B2
4 secondary outcomes
Change in proportion of platelets displaying CD62P
Time frame: Baseline, 2 weeks, 6 weeks, 10 weeks
Change in proportion of platelets displaying CD63
Time frame: Baseline, 2 weeks, 6 weeks, 10 weeks
Change in proportion of platelets displaying CD154
Time frame: Baseline, 2 weeks, 6 weeks, 10 weeks
Change in proportion of platelets displaying PAC1
Time frame: Baseline, 2 weeks, 6 weeks, 10 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ashraf Fawzy, MD, MPH principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aspirin 81mg, Aspirin 162 mg and Aspirin 325mg in people with Pulmonary Disease, Chronic Obstructive, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wendy Lorizio, MD, MPH (410-510-2449, wlorizi1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in urinary 11-dehydro-thromboxane B2 level (time frame: Baseline, week 2, week 6, week 10). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.