A Study to Evaluate the Safety and Tolerability of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease

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).