Long-term study of an inhaled drug for lung high blood pressure
Tests an inhaled drug long term in adults with lung high blood pressure.
Plain-language title generated from the registry record
Registry title: An Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Key facts
- Where
- Narita and Yokohama, JapanSee the 2 sites
- Phase
- Phase 3
Where in Japan
- JPN004Narita, JapanTaking people
- JPN007Yokohama, JapanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Insmed Incorporated
- Trial code
- NCT07234032EU 2025-521769-29-00
- Record updated
- 10 November 2026
- Original description
The primary objective of this study is to evaluate the safety and tolerability of the long-term use of TPIP in participants with PH-ILD from Study INS1009-311 (NCT07179380).Read full original descriptionShow less
A Long-term Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder for Treatment of Pulmonary Hypertension Associated With Interstitial Lung Disease
The primary objective of this study is to evaluate the safety and tolerability of the long-term use of TPIP in participants with PH-ILD from Study INS1009-311 (NCT07179380).
Inclusion: Participants who have completed the lead-in PH-ILD TPIP Study INS1009-311 (NCT07179380); Capable of giving signed informed consent that includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol; Agree not to participate in any other interventional trials or use investigational drugs or devices while participating in the INS1009-312 study.
Exclusion: Current use or expected need for pulmonary arterial hypertension (PAH)-approved therapy, including prostacyclin, prostacyclin analogues or other prostacyclin receptor agonists, endothelin receptor antagonists, and/or soluble guanylate cyclase stimulator, or any PH-ILD approved treprostinil therapy. Use of phosphodiesterase 5 inhibitors in line with applicable guidelines is allowed; Diagnosis of Pulmonary Hypertension World Health Organisation (WHO) Groups 1, 2, 4, or 5, or subtypes of PH WHO Group 3 other than interstitial lung disease (including combined pulmonary fibrosis and emphysema); Known hypersensitivity or contraindication to treprostinil or TPIP or TPIP formulation excipients (eg, mannitol, leucine); Note: Other protocol-defined inclusion/exclusion criteria may apply; Evidence of left ventricular failure, heart failure with preserved ejection fraction (HFpEF) or postcapillary PH; Participants who experienced any adverse events (AEs) evaluated as causally related to TPIP by the Investigator in a lead-in study, which in the opinion of the Investigator, could pose an unreasonable risk of continued treatments for the participant.