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ACTIVE NOT RECRUITING
NCT05649722
PHASE2/PHASE3

An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

Sponsor: Insmed Incorporated

View on ClinicalTrials.gov

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

DRUG

Treprostinil Palmitil Inhalation Powder

Oral inhalation using a capsule-based dry powder inhaler device.

DRUG

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