Kusterdingen

Researchers are evaluating the effects of Treprostinil Palmitil Inhalation Powder TPIP on adults with pulmonary hypertension associated with interstitial lung disease PH-ILD. The study aims to compare 24 weeks of once-daily TPIP treatment versus placebo to assess changes in exercise capacity and other health measures. This phase 3, randomized, double-blind, placebo-controlled trial seeks to better understand the treatments impact on this condition. Participants will be randomly assigned to receive either TPIP starting at 80 micrograms daily, with doses increased up to a maximum tolerated dose of 1280 micrograms, or a placebo inhaled once daily for 24 weeks. Both treatments are delivered via a capsule-based dry powder inhaler device. The study is conducted across multiple centers and includes careful monitoring of drug levels and health outcomes over the treatment period. During the study, participants will undergo assessments including the six-minute walk distance test to measure exercise capacity, blood tests to evaluate heart strain markers, and symptom questionnaires related to pulmonary fibrosis. Researchers will monitor safety, treatment adherence, and clinical events throughout the 24 weeks. The trial will also track time to clinical worsening and major health events, with detailed evaluations at baseline and regular intervals until the study ends.