RecruitingPhase 2NCT05937854

Breathe Easier With Tadalafil Therapy for Dyspnea in COPD-PH

Effect of PDE5 Inhibitor on Respiratory Symptoms in COPD Complicated by Pulmonary Hypertension

Sponsor

VA Office of Research and Development

Enrollment

126 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Chronic Obstructive Pulmonary Disease Dyspnea Pulmonary Hypertension

Summary

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.

Eligibility

Min Age: 35 YearsMax Age: 89 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether tadalafil (a medication that relaxes blood vessels, commonly known as Cialis) can reduce breathlessness in people who have both COPD (a chronic lung condition) and high blood pressure in the lungs. **You may be eligible if...** - You are between 35 and 89 years old - You have been diagnosed with COPD (confirmed by breathing tests or chest CT scan) - You have elevated pressure in the blood vessels of your lungs (confirmed by scan, echocardiogram, or heart catheterization) - You feel significantly short of breath in daily life - You have been on a long-acting bronchodilator (inhaler) for at least 4 weeks **You may NOT be eligible if...** - You have severe heart failure or unstable heart conditions - You take nitrate medications (like nitroglycerin) - You are currently using other pulmonary hypertension medications - You are pregnant or could become pregnant and are not using contraception - You have severe kidney or liver disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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