Actively Recruiting

Phase 3
Age: 18Years - 85Years
All Genders
NCT05844462

Tadalafil for Severe Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-01-12

200

Participants Needed

1

Research Sites

186 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Tadalafil for Severe Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 to less than 85 years
  • Dyspnea WHO functional class II to IV
  • Severe precapillary pulmonary hypertension with mean pulmonary artery pressure above 20 mmHg, normal pulmonary artery wedge pressure (≤15 mmHg), and pulmonary vascular resistance above 5 Wood units
  • COPD diagnosis confirmed by airflow limitation with FEV1/FVC ratio less than 0.70 after bronchodilator
  • No previous treatment with PDE5 inhibitors or other specific pulmonary hypertension treatments in the last 3 months
  • Stable COPD treatments for at least 1 month before screening
  • Stable supplemental long-term oxygen therapy if applicable for at least 1 month before screening
  • Ability to understand and follow study instructions and participate throughout the study
  • Written informed consent given prior to study procedures
  • Affiliated with a social security regime
Not Eligible

You will not qualify if you...

  • Any medical disorder or condition that impairs ability to participate or complete the study
  • Underlying medical disorders with life expectancy less than 12 months, including active cancer with localized or metastatic tumors
  • Pulmonary hypertension not caused by chronic respiratory diseases (groups 1, 2, 4, or 5)
  • Other respiratory diseases such as interstitial lung disease, sarcoidosis, lymphangioleiomyomatosis, histiocytosis, or untreated severe sleep apnea
  • Inability to perform or walk less than 50 meters in the 6-minute walk test
  • COPD exacerbation requiring hospitalization within 8 weeks before screening
  • COPD with mild (>80% predicted) or very severe (FEV1 <30% predicted) airflow limitation
  • Listed for lung transplantation at inclusion
  • Systolic left ventricular dysfunction with ejection fraction below 40%
  • Receiving state medical aid (AME)
  • Participation in another clinical trial within 3 months before or during this study
  • Pregnant or breastfeeding women, or women of childbearing potential not using effective contraception
  • Under guardianship or curatorship
  • Contraindications to tadalafil including severe renal failure, severe liver cirrhosis, severe low blood pressure, recent myocardial infarction, history of certain eye disorders, or hypersensitivity
  • Use of potent CYP3A4 inhibitors or inducers, soluble guanylate cyclase stimulators, other PDE5 inhibitors, nitrates, or doxazosin
  • Significant cardiovascular diseases including valve disease, pericardial constriction, cardiomyopathy, left ventricular dysfunction, life-threatening arrhythmias, unstable coronary artery disease, uncontrolled hypertension
  • Penile conditions such as angulation, fibrosis, Peyronie's disease, or history of priapism
  • Recent pulmonary or upper respiratory infection needing antibiotics or pulmonary embolism within 4 weeks before screening
  • Participation in respiratory rehabilitation within 4 weeks before screening or planned during study
  • Right heart failure needing catecholamine support within 4 weeks before screening

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Kremlin Bicêtre

Le Kremlin-Bicêtre, France, France, 94270

Actively Recruiting

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Research Team

D

David Pr MONTANI, PU-PH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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