Efficacy of Phosphodiesterase Type 5 Inhibitors in Severe Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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,

Locations
Other Locations
France
Kremlin Bicêtre
RECRUITING
Le Kremlin-bicêtre
Contact Information
Primary
David Pr MONTANI, PU-PH
david.montani@aphp.fr
01 45 21 78 85
Time Frame
Start Date: 2024-02-01
Estimated Completion Date: 2026-09
Participants
Target number of participants: 200
Treatments
Experimental: Experimental arm
Oral Tadalafil 40 mg or Tadalafil 20 mg \[(mild or moderate chronic renal failure or liver cirrhosis (Child-Pugh A or B)\].
Placebo_comparator: Control arm
Oral Placebo 40 mg or Placebo 20 mg \[(mild or moderate chronic renal failure or liver cirrhosis (Child-Pugh A or B)\].
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov