Actively Recruiting
Effect of PDE5 Inhibitor on Respiratory Symptoms in COPD Complicated by Pulmonary Hypertension
Led by VA Office of Research and Development · Updated on 2026-05-15
126
Participants Needed
5
Research Sites
N/A
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
Researchers are evaluating whether the drug tadalafil can improve shortness of breath in 126 Veterans with Chronic Obstructive Pulmonary Disease (COPD) complicated by pulmonary hypertension (PH). The study focuses on whether tadalafil reduces the severity of dyspnea, a common and debilitating symptom in COPD, and also examines its effects on quality of life, daily physical activity, exercise endurance, frequency of COPD flare-ups, lung blood pressure, and lung function. This is a phase 2, randomized, double-blind, placebo-controlled trial funded by the Department of Veterans Affairs. Participants will be randomly assigned to receive either daily oral tadalafil or an identical inactive placebo capsule for six months. The tadalafil dose will be one or two 20 mg tablets taken once daily. Both groups will continue their usual COPD care. The trial includes scheduled follow-up visits at 1, 2, 3, 4, 5, and 6 months, with assessments at 1, 3, and 6 months including questionnaires on dyspnea and testing of lung blood pressure and lung function. The study aims to determine if tadalafil improves respiratory symptoms more than placebo. During the study, participants will be closely monitored through clinic visits or telephone calls for side effects and safety. Researchers will collect data on patient-reported shortness of breath using a specific questionnaire, physical activity via daily step counts, exercise capacity by a 6-minute walk test, and health-related quality of life. The trial also includes imaging tests like CT scans and echocardiography to explore changes in pulmonary hypertension. Total participation is six months, with ongoing evaluation of lung health and symptom changes.
CONDITIONS
Brief Title
Breathe Easier With Tadalafil Therapy for Dyspnea in COPD-PH
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Outpatients with COPD confirmed by specific lung function tests or emphysema on chest CT
- Pulmonary hypertension documented by specific CT scan or echocardiography measurements or right heart catheterization within defined timeframes
- 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 before baseline
- Age between 35 and 89 years
- Women of childbearing potential must have used effective contraception for the past 3 months and have a negative pregnancy test at study visits
- Women not of childbearing potential must be surgically sterilized or post-menopausal
You will not qualify if you...
- Diagnosis of pulmonary hypertension from causes other than COPD as defined by WHO groups 1, 2, 3 (non-COPD), or 4
- Systemic hypotension with repeated low blood pressure readings
- Moderate or severe liver impairment
- Severe kidney impairment
- Significant heart valve disease or dysfunction as shown on echocardiography
- Any acute or chronic condition limiting ability to follow study requirements
- Recent unstable angina, heart attack, or stroke within 6 months
- Need for nitrate therapy
- Current use of PDE-5 inhibitors or pulmonary vasodilators besides oxygen
- History of certain retinal disorders
- Allergies or contraindications to PDE-5 inhibitors or related conditions
- Use of specific interacting medications
- Pregnancy, breastfeeding, or possible pregnancy
- Pulmonary veno-occlusive disease
- Low oxygen levels despite supplemental oxygen
- Untreated obstructive sleep apnea
- Recent changes in bronchodilator or diuretic therapy or pulmonary rehabilitation
- Employment as student or VA employee, impaired decision-making, illiteracy, non-English speakers, terminal illness
- Recent COPD or congestive heart failure exacerbation
- Current or planned use of doxazosin or similar medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive daily oral tadalafil or placebo for up to 6 months to assess the effect on dyspnea and physical activity.
Regular visits during the 6 months of treatment
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
R
Ronald H Goldstein, MD
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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