A study to evaluate Treprostinil Palmitil Inhalation Powder in Pulmonary Hypertension with ILD
Research type
Research Study
Full title
A Phase 2, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Safety and Tolerability of Treprostinil Palmitil Inhalation Powder in Participants with Pulmonary Hypertension Associated with Interstitial Lung Disease
IRAS ID
1005248
Contact name
Colin Urquhart
Contact email
Sponsor organisation
Insmed Incorporated
Eudract number
2021-003294-66
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to evaluate the safety and tolerability of Treprostinil Palmitil Inhalation Powder (TPIP), an experimental drug, in the treatment of Pulmonary Hypertension (PH) associated with Interstitial Lung Disease (ILD), and to learn more about TPIP and how it works in the human body. Approximately 32 men and women from the ages of 18 to 75 years, inclusive, with diagnosed PH-ILD are expected to participate in this study. The study is being conducted at centres in the United Kingdom and in countries around the world. Participants will be randomly assigned to receive either the study drug TPIP or placebo.
This is a double blind study, meaning that neither the study participants, the study doctor, nor the study staff will know what study drug (TPIP or placebo) participants have received until the study is completed.
All participants in the study will complete the same study procedures. The study will last approximately 24 weeks from the Screening Visit (Visit 1) to the end of the Follow-Up Visit/Phone Call (Visit 8/Day 140). There will be at least 8 visits at the study clinic (possibly more, depending on the number of visits required for Screening), including a Screening Period (occurring up to 30 days before participants receive the first dose of study drug), 6 Study Treatment Period Visits (Visits 2 through 7/Days 1 through 112), and 1 Follow-Up Visit/Phone Call (Visit 8/Day 140). The Follow-Up Visit may be either at the study clinic or conducted by telephone.REC name
South Central - Oxford A Research Ethics Committee
REC reference
22/SC/0180
Date of REC Opinion
25 Aug 2022
REC opinion
Further Information Unfavourable Opinion