Efficacy of Phosphodiesterase Type 5 Inhibitors in Severe Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease
ERASE PH-COPD is a randomized double-blind study, with 2 parallel groups. Patients with severe pulmonary hypertension due to chronic obstructive pulmonary disease, will be randomly assigned to receive Tadalafil orally or placebo.
• Patients ≥ 18 and \<85 years at inclusion,
• Dyspnea WHO functional class II to IV,
• Severe precapillary pulmonary hypertension defined by :
‣ a mean pulmonary artery pressure (mPAP) \>20
⁃ associated with normal pulmonary artery wedge pressure (PawP ≤15 mmHg)
⁃ and pulmonary vascular resistance (PVR) \>5 WU
• COPD diagnosed according to current international recommendation with persistent airflow limitation defined by post-bronchodilatator Forced expiratory volume in 1 second (FEV1) / forced vital capacity (FVC): FEV1/FVC \< 0.70,
• Naive patients from PDE5i (sildenafil, tadalafil) PH treatments and who did not receive other specific PH treatment in the last 3 months (bosentan, ambrisentan, macitentan, riociguat, epoprostenol, treprostinil, iloprost),
• Treatments for COPD need to be stable for at least 1 month before screening visit,
• Patients who fulfill criteria for a supplemental long-term oxygen therapy need to be supplied sufficiently before study entry. The amount of supplemental oxygen and the delivery method need to be stable for at least 1 month before screening visit,
• Patients who are able to understand and follow instructions and who are able to participate in the study for the entire period,
• Patients must have given their written informed consent to participate in the study after having received adequate previous information and prior to any study-specific procedures,
• Affiliation to a social security regime,