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New treatment option for Pulmonary Hypertension
Official title Tadalafil for Severe Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease
ClinicalTrials.gov ID: NCT05844462
What this study is testing
What is Tadalafil?
Tadalafil is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for pulmonary hypertension.
Also referred to as Talmanco.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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)
You likely can't join 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...
- Patients with underlying medical disorders and anticipated life expectancy below 12 months (eg active cancer disease with localized and/or...
- 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...
- 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,
See the full eligibility 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 \<...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Le Kremlin-Bicêtre, France, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Le Kremlin-Bicêtre, France, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.