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An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Sponsor: Insmed Incorporated
Summary
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 INS1009-211 (NCT05176951) and other lead-in studies of TPIP in participants with PH-ILD.
Official title: An Open-Label Extension Study to Assess the Safety, Tolerability, and Effectiveness of the Long-Term Use of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
31
Start Date
2023-05-11
Completion Date
2026-03-14
Last Updated
2026-02-27
Healthy Volunteers
No
Interventions
Treprostinil Palmitil Inhalation Powder
Oral inhalation using a capsule-based dry powder inhaler device.
Placebo
Oral placebo inhalation using a capsule-based dry powder inhaler device.
Locations (22)
ARG003
Autonomus City of Buenos Aires, Buenos Aires, Argentina
ARG001
Rosario, Santa Fe Province, Argentina
AUS005
Macquarie Park, New South Wales, Australia
BEL002
Liège, Belgium
GER006
Heidelberg, Baden-Wurttemberg, Germany
GER004
München, Bavaria, Germany
GER010
Giessen, Hesse, Germany
GER003
Essen, North Rhine-Westphalia, Germany
GER001
Dresden, Saxony, Germany
GER002
Berlin, Germany
GER012
Berlin, Germany
ITA004
Milan, Lombardy, Italy
ITA002
Monza, Lombardy, Italy
ITA001
Palermo, Sicily, Italy
ITA003
Naples, Italy
ESP003
Palma, Balearic Islands, Spain
ESP009
Santiago de Compostela, Galicia, Spain
ESP007
Oviedo, Principality of Asturias, Spain
ESP005
Barcelona, Spain
ESP010
Barcelona, Spain
GBR003
Clydebank, Glasgow, United Kingdom
GBR001
Sheffield, South Yorkshire, United Kingdom