COPDPhase 2NCT05567562

Anti-Platelets in Chronic Obstructive Pulmonary Disease

A Phase 2 study testing dual anti-platelet therapy in people with COPD and Emphysema, run by Brigham and Women's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a 6 week crossover study in current and former smokers with and without COPD to evaluate whether 2 weeks of dual antiplatelet therapy (aspirin 81mg and clopidogrel 75mg) improves pulmonary perfusion (i.e. blood flow in the lungs measured on a contrast CT scan) compared to placebo. Read more about this study

Who is it for?: Ages 50 to 80 yearsHealthy volunteers can take part
Conditions the study is for: COPD, Emphysema, Emphysema or COPD
What is being tested?: dual anti-platelet therapy
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 15 participants
Where: 1 siteUnited States
Study dates: 27 Mar 2024to 28 Feb 2025
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 50 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

COPD (FEV1/FVC < 0.7, FVC >= LLN), GOLD Stage I/II/III (FEV1 >= 40%)
Current or former smoker of at least 10 pack years
Normal lung function (FEV1/FVC >= 0.7, FEV1 and FVC >= LLN)
Current or former smoker of at least 10 pack years

Who cannot join

Platelet count < 150,000/dL or self-report of a bleeding disorder;
Regular use of aspirin, clopidogrel or another antiplatelet medication;
Allergy to aspirin, clopidogrel, albuterol or iodine/IV contrast;
BMI > 35;
History of intracranial hemorrhage, severe GI bleed or other life-threatening bleed;
Use of blood thinner (e.g. warfarin, lovenox or novel oral anti-coagulants);

Show all 23Show fewer

Continuous use of supplemental oxygen at home;
Regular use of an NSAID;
Daily use of oral steroids, theophylline, roflumilast, or loop diuretics;
History of organ transplant or autoimmune disease on systemic therapy (rheumatoid arthritis, lupus);
Use of a biologic medication with regular injections;
Other current lung disease (interstitial lung disease, idiopathic pulmonary fibrosis, asthma);
IV drug use within the last year;
History of lung surgery to remove part of the lung;
Known bullae or advanced destructive emphysema in more than 1/3 of the lungs;
Treatment for cancer (systemic therapy or surgical/radiation within the thorax) in the last 12 months;
Known diagnosis of pulmonary hypertension;
Known systolic heart failure (RV or LV EF < 40%);
Acute or chronic renal insufficiency (estimated glomerular filtration rate [GFR] <60 mL/min/1.73 m2 or self-report). GFR will be calculated using the CKD-EPI equation;
Current or planned pregnancy in the next year;
Regular marijuana smoking;
Exacerbation of respiratory symptoms within the previous 6 weeks, such as that requiring hospitalization, oral prednisone or antibiotics to control symptoms, or longer and not yet returned to baseline; and
Chest, abdominal or eye surgery, or a heart attack or stroke, within the last 3 months.

Trial locations and contacts

1 site in 1 country.

United States1 site

Brigham and Women's Hospital
Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: Dual Anti-platelet Therapy in Chronic Obstructive Pulmonary Disease Study

Read the detailed description

This is a single-center Phase IIa randomized double-blind crossover study in smokers with and without chronic obstructive pulmonary disease (COPD) to test whether dual antiplatelet therapy (aspirin 81mg and clopidogrel 75mg) improves pulmonary perfusion (i.e. blood flow in the lungs) compared to placebo.

We will enroll 30 subjects (20 with COPD, 10 without) who will each take part for 6 weeks. Participants and researchers will be blinded, they will not know which medications they are on first. Each participant will be asked to take aspirin and clopidogrel together for 2 weeks and also matching placebos for 2 weeks, with a 2 week washout period in between. Pulmonary blood flow will be evaluated with a contrast-enhanced CT scan of the chest two times over the 6 week study.

Conditions: COPD, Emphysema, Emphysema or COPD
Being tested: dual anti-platelet therapy, Placebo
Keywords: Platelet Dysfunction, Pulmonary Blood Vessel Injury, COPD, Emphysema
Medical subject headings: Pulmonary Disease, Chronic Obstructive, Emphysema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

dual anti-platelet therapyCombination product
Also called aspirin 81mg EC tab, clopidogrel 75mg tab
dual anti-platelet therapy
PlaceboDrug
Placebo

Study groups in NCT05567562
Study group	Role	What they receive
COPD Cases: Dual antiplatelet therapy first, then placebo	Experimental	Dual antiplatelet therapy (aspirin 81mg and clopidogrel 75mg) will be given for 2 weeks, followed by 2 weeks without intervention, then 2 weeks of placebo Receives: Combination Product: dual anti-platelet therapy; Drug: Placebo
COPD Cases: Placebo first, then dual antiplatelet therapy	Placebo comparator	Placebos for each therapy (2 pills) will be given for 2 weeks, followed by 2 weeks without intervention, then 2 weeks of dual antiplatelet therapy Receives: Combination Product: dual anti-platelet therapy; Drug: Placebo
Controls: Dual antiplatelet therapy first, then placebo	Active comparator	Dual antiplatelet therapy (aspirin 81mg and clopidogrel 75mg) will be given for 2 weeks, followed by 2 weeks without intervention, then 2 weeks of placebo Receives: Combination Product: dual anti-platelet therapy; Drug: Placebo
Controls: Placebo first, then dual antiplatelet therapy	Placebo comparator	Placebos for each therapy (2 pills) will be given for 2 weeks, followed by 2 weeks without intervention, then 2 weeks of dual antiplatelet therapy Receives: Combination Product: dual anti-platelet therapy; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Pulmonary Microvascular Blood Volume, CV
Coefficient of variation (CV) of pulmonary microvascular blood volume on dual energy CT scan, comparing on dual antiplatelet therapy to placebo
Measured: After 2 weeks of therapy

Secondary outcomes (2)

Pulmonary Microvascular Blood Volume
Pulmonary microvascular blood volume on dual energy CT scan, comparing on dual antiplatelet therapy to placebo
Measured: After 2 weeks of therapy
Oxygen Saturation
Resting oxygen saturation
Measured: After 2 weeks of therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Mar 202428 Feb 2025

First posted5 Oct 2022
Study start27 Mar 2024
Primary completion28 Feb 2025
Study completion28 Feb 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for COPDStudies of the same condition, open and under way.
More trials run by Brigham and Women's HospitalThe 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 2
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Model description: Double-blind crossover study is a Phase 2 interventional study to assess whether dual-anti platelet therapy improves pulmonary blood flow compared to placebo
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05567562
Sponsor's protocol ID: 2022P002327
Other IDs: K23HL141651
Status last verified: Apr 2026
First submitted: 3 Oct 2022
Last updated: 14 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: This is a small single-center study, we do not plan to share participant level data

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia

All COPD trials

Study at a glance

From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dual Anti-platelet Therapy in Chronic Obstructive Pulmonary Disease Study
ClinicalTrials.gov ID: NCT05567562
Acronym / sponsor ID: 2022P002327
Conditions: COPD, Emphysema, Emphysema or COPD
Keywords: Platelet Dysfunction, Pulmonary Blood Vessel Injury, COPD, Emphysema
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Brigham and Women's HospitalUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: 27 Mar 2024 (actual)
Primary completion: 28 Feb 2025 (actual)
Study completion: 28 Feb 2025 (actual)
First posted: 5 Oct 2022 (actual)
Results: Posted 14 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4
Model description: Double-blind crossover study is a Phase 2 interventional study to assess whether dual-anti platelet therapy improves pulmonary blood flow compared to placebo

Arm	Type	Receives
COPD Cases: Dual antiplatelet therapy first, then placebo	Experimental	Combination Product: dual anti-platelet therapy, Drug: PlaceboDual antiplatelet therapy (aspirin 81mg and clopidogrel 75mg) will be given for 2 weeks, followed by 2 weeks without intervention, then 2 weeks of placebo
COPD Cases: Placebo first, then dual antiplatelet therapy	Placebo comparator	Combination Product: dual anti-platelet therapy, Drug: PlaceboPlacebos for each therapy (2 pills) will be given for 2 weeks, followed by 2 weeks without intervention, then 2 weeks of dual antiplatelet therapy
Controls: Dual antiplatelet therapy first, then placebo	Active comparator	Combination Product: dual anti-platelet therapy, Drug: PlaceboDual antiplatelet therapy (aspirin 81mg and clopidogrel 75mg) will be given for 2 weeks, followed by 2 weeks without intervention, then 2 weeks of placebo
Controls: Placebo first, then dual antiplatelet therapy	Placebo comparator	Combination Product: dual anti-platelet therapy, Drug: PlaceboPlacebos for each therapy (2 pills) will be given for 2 weeks, followed by 2 weeks without intervention, then 2 weeks of dual antiplatelet therapy

Who may qualify

Ages: 50 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

COPD (FEV1/FVC < 0.7, FVC >= LLN), GOLD Stage I/II/III (FEV1 >= 40%)
Current or former smoker of at least 10 pack years
Normal lung function (FEV1/FVC >= 0.7, FEV1 and FVC >= LLN)
Current or former smoker of at least 10 pack years

Key exclusion criteria (23 listed)

Platelet count < 150,000/dL or self-report of a bleeding disorder;
Regular use of aspirin, clopidogrel or another antiplatelet medication;
Allergy to aspirin, clopidogrel, albuterol or iodine/IV contrast;
BMI > 35;
History of intracranial hemorrhage, severe GI bleed or other life-threatening bleed;

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
dual anti-platelet therapyAlso: aspirin 81mg EC tab, clopidogrel 75mg tabdual anti-platelet therapy	Combination product	COPD Cases: Dual antiplatelet therapy first, then placebo, COPD Cases: Placebo first, then dual antiplatelet therapy, Controls: Dual antiplatelet therapy first, then placebo, Controls: Placebo first, then dual antiplatelet therapy
PlaceboPlacebo	Drug	COPD Cases: Dual antiplatelet therapy first, then placebo, COPD Cases: Placebo first, then dual antiplatelet therapy, Controls: Dual antiplatelet therapy first, then placebo, Controls: Placebo first, then dual antiplatelet therapy

Primary outcome

Pulmonary Microvascular Blood Volume, CV
Time frame: After 2 weeks of therapy
Coefficient of variation (CV) of pulmonary microvascular blood volume on dual energy CT scan, comparing on dual antiplatelet therapy to placebo

2 secondary outcomes

Pulmonary Microvascular Blood Volume
Time frame: After 2 weeks of therapy
Oxygen Saturation
Time frame: After 2 weeks of therapy

Results and safety

Results posted to the registry on 14 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
COPD Cases: On Dual Antiplatelet Therapy First	5	5
COPD Cases: On Placebo First	5	5
Controls: On Dual Antiplatelet Therapy First	3	2
Controls: On Placebo First	2	2

Primary outcome: Pulmonary Microvascular Blood Volume, CV

Time frame: After 2 weeks of therapy. Mean (Standard Deviation). Unit: CV

Measure	On Dual Anti-platelet Therapy n = 14	On Placebo n = 14	On Dual Anti-platelet Therapy, COPD n = 10	On Placebo, COPD n = 10	On Dual Anti-platelet Therapy, Controls n = 4	On Placebo, Controls n = 4
Value	0.89 (0.079)	0.88 (0.072)	0.92 (0.064)	0.91 (0.052)	0.81 (0.051)	0.80 (0.042)

On Dual Anti-platelet Therapy vs On Placebo: p = 0.84, Wilcoxon (Mann-Whitney)
On Dual Anti-platelet Therapy, COPD vs On Placebo, COPD: p = 0.74, Wilcoxon (Mann-Whitney)
On Dual Anti-platelet Therapy, Controls vs On Placebo, Controls: p = 0.89, Wilcoxon (Mann-Whitney)

Population analysed: This is a crossover study and each participant received each treatment. The analyses presented are 1) All subjects comparing the outcome measures on and off treatment (N=14), 2) COPD subjects comparing the outcome measures on and off treatment (N=10), and 3) Control subjects comparing the outcome measures on and off treatment (N=4).

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were attributed to a study arm from the time they started the intervention until 2 weeks after the last dose, typically 8 weeks with a maximum of 10 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
COPD on Dual Anti-platelet Therapy	0 of 10 (0%)	5 of 10 (50%)	0 of 10
COPD on Placebo	0 of 10 (0%)	2 of 10 (20%)	0 of 10
Control Subjects on Dual Anti-platelet Therapy	0 of 4 (0%)	2 of 4 (50%)	0 of 4
Control Subjects on Placebo	0 of 5 (0%)	0 of 5 (0%)	0 of 5

Limitations and caveats (from the sponsor): We had a lower total number of participants due to difficulty recruiting and time constraints, thus we have lower power than expected. For AEs: 2 subjects (1 COPD, 1 control) had lung nodules on CT after dual antiplatelet therapy (1st trt) that were not seen after placebo (2nd trt). They did not get any antibiotics. 2 subjects with COPD had infiltrates on CT after dual antiplatelet therapy (1st trt) and were treated with azithro, 1 improved and 1 did not, both still seen on placebo (2nd trt).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. This is a small single-center study, we do not plan to share participant level data

Related trials for COPD

Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia

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. This study is not recruiting at the moment.

Carrie L Pistenmaa, MD, MS principal investigator

Brigham and Women's Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing dual anti-platelet therapy in people with COPD and Emphysema, run by Brigham and Women's Hospital 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 23 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: finished, as of the sponsor's last update on 14 May 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pulmonary Microvascular Blood Volume, CV (time frame: After 2 weeks of therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05567562.

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 14 May 2026.