a study to evaluate the safety and tolerability of treprostinil palmitil inhalation powder in participants with pulmonary hypertension associated with interstitial lung disease

Conditions: Pulmonary Hypertension

Summary: the primary objective of this study is to evaluate the safety and tolerability of treprostinil palmitil inhalation powder (tpip) compared with placebo


Eligibility criteria:
inclusion criteria: * males and females must be ≥ 18 to ≤ 80 years of age at the time of signing the informed consent form (icf). * diagnosis of pulmonary hypertension (ph) associated with interstitial lung disease (ild) (including idiopathic interstitial pneumonia \[iip\], idiopathic pulmonary fibrosis \[ipf\], connective tissue disease \[ctd\], sarcoidosis). * male and female participants must use contraceptives that are consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * male participants: male participants who are not sterile, with female partners of childbearing potential, must be using effective contraception from day 1 to at least 90 days after the last dose of study drug. male participants with women of child bearing potential (wocbp) partner must use a condom in order to avoid potential exposure to embryo/fetus. - female participants: women must be postmenopausal (defined as no menses for 12 months without an alternative medical cause), surgically sterile, (ie,hysterectomy and/or bilateral salpingo-oophorectomy) or using highly effective contraception methods (ie, methods that alone or in combination achieve \<1% unintended pregnancy rates per year when used consistently and correctly) from day 1 to at least 90 days after the last dose of study drug. - capable of giving signed informed consent that includes compliance with the requirements and restrictions listed in the icf and in this protocol. exclusion criteria: * primary diagnosis of chronic obstructive pulmonary disease (copd). * allergy, or documented hypersensitivity or contraindication to tpip or treprostinil (tre) or mannitol (an excipient of the tpip formulation). * received or currently treated with riociguat, endothelin receptor antagonists, selexipag, phosphodiesterase 5 (pde5) inhibitors and/or prostacyclin analogues within 30 days prior to screening. * started therapy with pirfenidone or nintedanib \< 90 days prior to screening, or, if already receiving either medication, there is a dose change within 30 days of screening visit. * any known ventricular or supraventricular tachyarrhythmia (except for paroxysmal atrial fibrillation), and/or any symptomatic bradycardia. * history of heart disease including left ventricular ejection fraction (lvef) ≤ 40% or clinically significant valvular, constrictive, or symptomatic atherosclerotic heart disease (eg, stable angina, myocardial infarction, etc). * participation in a cardiopulmonary rehabilitation program within 30 days of the first screening visit. participation in the maintenance program of a cardiopulmonary rehabilitation program is allowed. * acutely decompensated heart failure within 30 days of screening visit. * active and current symptomatic coronavirus disease 2019 (covid-19) and/or previous diagnosis of moderate to severe disease, or hospitalization due to covid-19. * supplemental oxygen requirement \> 10l/min at rest at screening. * exacerbation of underlying lung disease or active pulmonary or upper respiratory infection within 30 days of the first dose of study drug (may be rescreened at appropriate time). * current or recent (past 30 days) lower respiratory tract infection (may be rescreened at appropriate time). * any form of congenital heart disease or congenital heart defect (repaired or unrepaired) other than a patent foramen ovale. * history of alcohol or drug abuse within 6 months prior to screening. * current use of cigarettes (as defined by center for disease control (cdc)) or e-cigarettes: an adult who has smoked at least 100 cigarettes in his or her lifetime and who currently smokes either every day or some days. * participants who currently inhale marijuana (recreational or medical). * acute or chronic impairment (other than dyspnea), limiting the ability to comply with study requirements, in particular with 6-minute walk test (6mwt) (eg, angina pectoris, claudication, musculoskeletal disorder, need for walking aids).

Keywords: pulmonary hypertension interstitial lung disease treprostinil palmitil