Informations générales (source: ClinicalTrials.gov)
Efficacy of Phosphodiesterase Type 5 Inhibitors in Severe Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease
Interventional
Phase 3
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
février 2024
septembre 2026
18 septembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP Assistance publique - Hôpitaux de Paris | 13/12/2025 07:34:44 | Contacter | |||
| AP-HP - Hôpital Bicêtre | |||||
| AP-HP - Hôpital Bichat | |||||
| AP-HP - Hôpital Europeen Georges Pompidou | |||||
Critères
Tous
Inclusion Criteria:
- 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,
- 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,
- Patients with a medical disorder, condition, or history of such that would impair
the patient's ability to participate or complete this study in the opinion of the
investigator,
- Patients with underlying medical disorders and anticipated life expectancy below 12
months (eg active cancer disease with localized and/or metastasized tumor mass),
- PH not due to chronic respiratory diseases (group 1, 2, 4 or 5 of the clinical
classification of PH),
- Other respiratory diseases: interstitial lung disease, sarcoidosis,
lymphangioleiomyomatosis, histiocytosis, or untreated severe sleep apnea disorders,
- 6-minutes walk distance < 50 m or patients unable to perform the 6-minutes walk
test,
- Exacerbation of the COPD requiring hospitalization in the last 8 weeks before
screening,
- COPD with mild (> 80% predicted value) or severe (FEV1 <30% predicted value) airflow
limitation,
- Patients listed for lung transplantation at the time of inclusion,
- Systolic left ventricular dysfunction with left ventricular ejection fraction <40%
on echocardiography,
- Patient on AME (state medical aid),
- Participation in another clinical trial during the preceding 3 months and during the
study,
- Pregnant women, or breast-feeding women, or women with childbearing potential not
using a combination of condoms and a safe and highly effective contraception method
(hormonal contraception with implants or oral contraceptives, or intrauterine
devices) and one month after the end of the study, WOCBP include any woman who has
experienced menarche and who has not undergone successful surgical sterilization
(hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not
postmenopausal [defined as amenorrhea ≥ 12 consecutive months; or women on hormone
replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH)
level > 35 mIU/mL],
- Patient under guardianship or curatorship
Non-inclusion criteria related to treatment by tadalafil:
- Contraindication to tadalafil:
- Severe renal failure (creatinine clearance < 30 mL/min/1,73 m2)
- Severe liver cirrhosis Child-Plugh C
- Severe systemic hypotension <90/50
- Recent myocardial infarction <90 days
- Medical history of anterior ischemic optic neuropathy
- Hypersensitivity to tadalafil or any of the excipients
- Concomitant use of potent CYP3A4 inhibitors or inducers, soluble guanylate cyclase
stimulator (riociguat), other PDE5 inhibitors or nitrates or doxazosin
- Cardiovascular diseases:
- Clinically significant aortic and mitral valve disease
- Pericardial constriction
- Restrictive or congestive cardiomyopathy
- Significant left ventricular dysfunction
- Life-threatening arrhythmias
- Symptomatic coronary artery disease
- Uncontrolled hypertension.
- Angulation of the penis, cavernosal fibrosis, Peyronie's disease or history of
priapism
- Pulmonary or upper respiratory infection requiring antibiotics, or pulmonary
embolism in the last 4 weeks before screening
- Participation in a respiratory rehabilitation program within the 4 weeks prior to
screening or scheduled during the study period
- Right heart failure necessitating catecholamine support within the 4 weeks prior to
screening.