Actively Recruiting
Breathe Easier With Tadalafil Therapy for Dyspnea in COPD-PH
Led by VA Office of Research and Development · Updated on 2026-05-14
126
Participants Needed
5
Research Sites
256 weeks
Total Duration
On this page
Sponsors
V
VA Office of Research and Development
Lead Sponsor
V
VA Boston Healthcare System
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Breathe Easier With Tadalafil Therapy for Dyspnea in COPD-PH
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Outpatients with COPD defined by airflow limitation on spirometry or emphysema on chest CT confirmed by study review
- Documented pulmonary hypertension by specific CT scan or echocardiography or right heart catheterization criteria
- Dyspnea with a score of at least 20 on the UCSD Shortness of Breath Questionnaire at baseline
- Treatment with at least one long-acting bronchodilator for at least 4 weeks
- Age between 35 and 89 years
- Women of childbearing potential must use contraception or meet specified criteria and have a negative pregnancy test at baseline
- Women not of childbearing potential must have surgical sterilization or be post-menopausal
You will not qualify if you...
- Diagnosis of pulmonary hypertension from groups other than COPD-related (WHO Group 1, 2, 3 not due to COPD, 4, or other forms)
- Systemic hypotension with repeated systolic blood pressure below 89 mmHg
- Moderate or severe liver impairment (Child-Pugh B or C)
- Severe kidney impairment (GFR below 30 ml/min/1.73 m2)
- Significant heart valve disease or dysfunction on echocardiography
- Any acute or chronic condition limiting study compliance
- Unstable angina, recent heart attack or stroke within 6 months
- Need for nitrate therapy
- Use of other PDE-5 inhibitors or pulmonary vasodilators except oxygen
- History of certain retinal disorders
- Allergy to PDE-5 inhibitors or contraindications like sickle cell anemia or bleeding disorders
- Use of specific interacting medications (e.g., rifampin, antifungal azoles, protease inhibitors)
- Pregnancy or breastfeeding
- Pulmonary veno-occlusive disease
- Hypoxia with oxygen saturation below 90% on supplemental oxygen
- Untreated obstructive sleep apnea
- Recent changes in bronchodilator, diuretic therapy, or pulmonary rehabilitation
- Students, VA employees, those with impaired decision-making, illiterate or non-English speakers, and terminally ill patients
- Recent COPD or heart failure exacerbation within 4 weeks
- Ongoing doxazosin therapy or planned use during the trial
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States, 30033-4004
Actively Recruiting
3
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130-4817
Actively Recruiting
4
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Omaha, Nebraska, United States, 68105-1850
Actively Recruiting
5
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, United States, 02908-4734
Actively Recruiting
Research Team
S
Sharon I Rounds, MD
CONTACT
R
Ronald H Goldstein, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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