Breathe Easier With Tadalafil Therapy for Dyspnea in COPD-PH
Eligible age
35–89 yrs
Accepts
All genders
Locations
5 states
Healthy volunteers
No
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About this study
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.
Sponsor: VA Office of Research and Development
You may qualify if…
- ✓ 1. Outpatients with COPD, defined as airflow limitation with post-bronchodilator obstruction on baseline visit spirometry, identified by FEV1/FVC \< 70% or \< the lower limit of normal (5th percentile of a normal population based on Global Lung Function Initiative reference equations), OR any emphysema on chest CT noted in a clinical radiology report confirmed by study investigator review.
- ✓ 2. Eligible subjects must have PH documented as follows:
- ✓ 1. Main Pulmonary Artery/Ascending Aorta (PA/A) diameter \> 0.90 on clinically available CT scans within 12 months OR
- ✓ 2. Main Pulmonary Artery diameter \> 30.8mm on clinically available CT scans within 12 months OR
- ✓ 3. outpatient echocardiography done within 6 months of enrollment demonstrating PA sys \> 34 mmHg OR
- ✓ 4. Mean Pulmonary Artery Pressure \> 20 on Right Heart Catheterization done within 6 months of enrollment and when Veteran is clinically stable.
- ✓ 3. Eligible subjects must be dyspneic, as quantitated by a score of at least 20 on the baseline UCSD Shortness of Breath Questionnaire, assessed at the time of the baseline visit.
- ✓ 4. Treatment with at least one long-acting bronchodilator for at least 4 weeks, assessed at the time of the baseline visit by chart review and patient interview.
You may not qualify if…
- ✕ 1. Diagnosis of PH in the following subgroups of the updated WHO Clinical Classification:
- ✕ 1. Group 1 (Idiopathic, heritable, drug- or toxin-induced, Pulmonary Arterial Hypertension associated with connective tissue disease, congenital heart disease)
- ✕ 2. Group 2 (left atrial hypertension)
- ✕ 3. Group 3 PH not attributable to COPD
- ✕ 4. Group 4 (chronic thromboembolic PH) or other forms of PH not associated with primary lung disease.
- ✕ 2. 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).
- ✕ 3. Moderate or severe hepatic impairment (Child-Pugh B and C).
- ✕ 4. Severe renal insufficiency (GFR \<30 ml/min/1.73 m2)
Where it's recruiting
Source: ClinicalTrials.gov · NCT05937854 · last updated 2026-05-15