Tadalafil for Severe Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease

NCT05844462 | Recruiting Phase 3 DMC

• 1 other identifier: APHP211052
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Hypertension; Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 6 minute Walk

  The distance cover in meter during a 6-minute walk at week 16 post-randomization for patients treated with tadalafil compared to placebo

  16 weeks

Study Arms (2)

Experimental arm

EXPERIMENTAL

Oral Tadalafil 40 mg or Tadalafil 20 mg \[(mild or moderate chronic renal failure or liver cirrhosis (Child-Pugh A or B)\].

Drug: Tadalafil

Control arm

PLACEBO COMPARATOR

Oral Placebo 40 mg or Placebo 20 mg \[(mild or moderate chronic renal failure or liver cirrhosis (Child-Pugh A or B)\].

Drug: Placebo

Interventions

Tadalafil DRUG

Oral Tadalafil

Also known as: Talmanco

Experimental arm

Placebo DRUG

Oral Placebo

Control arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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,
• 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,
• 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
• Contraindication to tadalafil:
• Severe renal failure (creatinine clearance \< 30 mL/min/1,73 m2)
• Severe liver cirrhosis Child-Plugh C

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Kremlin Bicêtre

Le Kremlin-Bicêtre, France, 94270, France

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary; Pulmonary Disease, Chronic Obstructive

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Central Study Contacts

David Pr MONTANI, PU-PH

CONTACT

01 45 21 78 85; david.montani@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 6, 2023
• Study Start: February 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

FR (1)