Phase 2
N=15
Anti-Platelets in Chronic Obstructive Pulmonary Disease
COPD · Emphysema · Emphysema or COPD
Bottom Line
View on ClinicalTrials.gov: NCT05567562 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Pulmonary Microvascular Blood Volume, CV — 0.89; 0.88; 0.92; 0.91 CV — p=0.84
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- dual anti-platelet therapy (Combination_product); Placebo (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Feb 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pulmonary Microvascular Blood Volume, CV |
0.89; 0.88; 0.92; 0.91; 0.81; 0.80 | 0.84 |
| SECONDARY Pulmonary Microvascular Blood Volume |
602.8; 595.0; 581.7; 592.9; 655.5; 600.2 | 0.98 |
| SECONDARY Oxygen Saturation |
95.64; 95.71; 94.9; 95.5; 97.5; 96.25 | 0.75 |
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.
Eligibility Criteria
Inclusion Criteria - COPD Cases:
- COPD (FEV1/FVC = LLN), GOLD Stage I/II/III (FEV1 >= 40%)
- Current or former smoker of at least 10 pack years
Inclusion Criteria - Controls:
- Normal lung function (FEV1/FVC >= 0.7, FEV1 and FVC >= LLN)
- Current or former smoker of at least 10 pack years
Exclusion Criteria
- Platelet count 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);
- 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.
Data sourced from ClinicalTrials.gov (NCT05567562). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.