Tadalafil for Severe Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease (ERASE PH-COPD)

August 19, 2026 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Pulmonary hypertension (PH) is a frequent complication of chronic parenchymal lung diseases particularly in chronic obstructive pulmonary disease (COPD) and represents one of the major cause of all causes of PH. When present, PH contributes to more severe symptoms; exercise intolerance and can lead to right heart failure, which portends a worse prognosis and an increased mortality. Mechanisms of severe PH in chronic respiratory diseases are complex and include rarefaction of vascular bed, endothelial dysfunction and exaggerated pulmonary arterial remodeling. In patients with idiopathic pulmonary arterial hypertension (PAH), targeted medical therapies, including oral phosphodiesterase type 5 inhibitors (PDE5i), improve endothelial cell dysfunction, have vasodilatory and anti-proliferative effects on the pulmonary vasculature, reduce the right ventricular afterload and improve symptoms, exercise capacity, and clinical outcomes in randomized trials. Several studies suggested a potential effect of PDE5i in COPD on dyspnea, exertional capacity and quality of life. However, these results were based on including small number of patients with heterogenous severity of lung disease and usually without complete hemodynamic evaluation. Data are lacking regarding the benefit/risk ratio of these treatments in the context of severe PH due to COPD. The main objective to this randomized controlled trial (16 weeks) is to evaluate the efficacy and safety of an oral PDE5i, tadalafil, in patients with severe PH due to COPD.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
    • France
      • Le Kremlin-Bicêtre, France, France, 94270
        • Recruiting
        • Kremlin Bicêtre
        • Contact:
          • David Pr MONTANI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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,

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)].
Drug: Tadalafil
Oral Tadalafil
Other Names:
  • ADCIRCA
  • Talmanco
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)].
Drug: Placebo
Oral Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
6 minute Walk
Time Frame: 16 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 25, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • APHP211052

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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