Breathe Easier With Tadalafil Therapy for Dyspnea in COPD-PH (NCT05937854)
🩺 Plain-English Summary (8th-Grade Level)
The investigators will study whether the drug tadalafil improves shortness of breath in 126 Veterans with Chronic Obstructive Pulmonary Disease (COPD) and high blood pressure in the lungs. The investigators will also assess whether tadalafil improves quality of life, home daily physical activity, exercise endurance, the frequency of acute flares of COPD, blood pressure in the lungs, and lung function. Veterans who enroll in the trial will be allocated by chance to either active tadalafil or an inactive identical capsule (placebo). Neither the Veteran nor the investigator will know whether the Veteran is taking tadalafil or placebo. Veterans will be followed closely in clinic or by telephone at 1, 2, 3, 4, 5, and 6 months, with attention to side effects and safety. At 1,3, and 6 months the investigators will repeat the questionnaires and testing of blood pressures in the lung and lung function. The investigators anticipate that the results of this study will determine whether tadalafil improves shortness of breath when added to usual medications for COPD.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (16 items) and avoid the listed exclusions (25 items).
Location: Rocky Mountain Regional VA Medical Center, Aurora, CO — Aurora, Colorado
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Diagnosis of PH in the following subgroups of the updated WHO Clinical Classification:
- Group 1 (Idiopathic, heritable, drug- or toxin-induced, Pulmonary Arterial Hypertension associated with connective tissue disease, congenital heart disease)
- Group 2 (left atrial hypertension)
- Group 3 PH not attributable to COPD
- Group 4 (chronic thromboembolic PH) or other forms of PH not associated with primary lung disease.
- Systemic hypotension in the ambulatory setting (at least 3 reproducible measurements of systolic BP \<89 mmHg, recorded by a health care provider over 1 week).
- Moderate or severe hepatic impairment (Child-Pugh B and C).
- Severe renal insufficiency (GFR \<30 ml/min/1.73 m2)
- Echocardiography within 6 months showing greater than moderate aortic stenosis (aortic valve area \<1.0 cm2), greater than moderate mitral regurgitation, or diastolic dysfunction (Any two of the following: Average E/e' \>14, Septal e' velocity \< 7 or lateral e' velocity \<10, LA volume index \> 34 ml/m2). LVEF \< 50%. Any aortic or mitral valve replacement.
- Any acute or chronic impairment (other than dyspnea) that limits ability to comply with the study requirements.
- Current unstable angina, myocardial infarction or stroke within 6 months.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (5 Sites)
- Rocky Mountain Regional VA Medical Center, Aurora, CO — Aurora, Colorado
- Atlanta VA Medical and Rehab Center, Decatur, GA — Decatur, Georgia
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA — Boston, Massachusetts
- Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE — Omaha, Nebraska
- Providence VA Medical Center, Providence, RI — Providence, Rhode Island
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.